TARGET Clinical Trial Identifier: NCT American College of Rheumatology Annual Meeting; November 7-11, 2015; San Francisco, CA
|
|
- Dwayne Hugh Short
- 5 years ago
- Views:
Transcription
1 Efficacy and Safety of Sarilumab in Combination With csdmards in Patients With Active Rheumatoid Arthritis Who Were Inadequate Responders or Intolerant of Anti-TNF Therapy: Results From a Phase 3 Study Roy Fleischmann, 1 Geraldo da Rocha Castelar-Pinheiro, 2 Jan Brzezicki, 3 Pawel Hrycaj, 4 Yong Lin, 5 Janet van Adelsberg, 6 Neil M.H. Graham, 6 Hubert van Hoogstraten, 5 Deborah Bauer, 5 Gerd R. Burmester 7 1 Metroplex Clinical Research Center, Dallas, TX, USA; 2 Discipline of Rheumatology, Rio de Janeiro State University, Rio de Janeiro, Brazil; 3 Centrum Kliniczno-Badawcze, Elblag, Poland; 4 Department of Rheumatology and Clinical Immunology, Poznań University of Medical Sciences, Poznań, Poland; 5 Sanofi, Bridgewater, NJ, USA; 6 Regeneron Pharmaceuticals, Inc, Tarrytown, NY, USA; 7 Department of Rheumatology and Clinical Immunology, Charité University Medicine, Berlin, Germany TARGET Clinical Trial Identifier: NCT
2 Disclosures Roy Fleischmann has received research grants from AbbVie, Amgen, Ardea, AstraZeneca, BMS, Celgene, GSK, Janssen, Eli Lilly, Merck, Pfizer, Roche, Sanofi Aventis, and UCB; and has received consulting fees from AbbVie, Akros, Amgen, AstraZeneca, BMS, Janssen, Eli Lilly, Pfizer, Roche, and UCB Geraldo da Rocha Castelar-Pinheiro has received consulting fees from AbbVie, AstraZeneca, GSK, Hospira, Janssen, Pfizer, Roche, RuiYi, and Sanofi Jan Brzezicki and Pawel Hrycaj have nothing to disclose Yong Lin is an employee of Sanofi and may hold stock and/or stock options in the company Janet van Adelsberg and Neil M.H. Graham are employees of Regeneron Pharmaceuticals, Inc, and may hold stock and/or stock options in the company Hubert van Hoogstraten and Deborah Bauer are employees of Sanofi and may hold stock and/or stock options in the company Gerd R. Burmester has received research grants from AbbVie, Pfizer, UCB, and Roche; has received consulting fees from AbbVie, BMS, Pfizer, Merck, MedImmune, UCB, and Roche; and has served on speakers bureaus for AbbVie, BMS, Pfizer, Merck, UCB, and Roche This study was sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. Presentation development support was provided by Kristi Porter, PhD, MedThink SciCom, and funded by Sanofi and Regeneron Pharmaceuticals, Inc 2
3 Background Sarilumab is an investigational human monoclonal antibody directed against the interleukin 6 receptor Sarilumab + MTX has previously demonstrated efficacy and safety in patients with active, moderate-to-severe RA 1 The TARGET study (NCT ) evaluated the efficacy and safety of sarilumab + csdmards in adults with active, moderate-to-severe RA with inadequate response to or intolerance of 1 TNF inhibitor(s) csdmard, conventional synthetic disease-modifying antirheumatic drug; MTX, methotrexate; RA, rheumatoid arthritis; TNF, tumor necrosis factor. 1. Genovese et al. Arthritis Rheumatol. 2015;67:
4 TARGET Study Design 12 weeks (rescue a ) 24 weeks N=546 randomized Sarilumab 200 mg q2w + csdmards (n=184) Inadequate response or intolerance to anti-tnf R Sarilumab 150 mg q2w + csdmards Placebo q2w + csdmards 1 EP HAQ-DI 1 EP ACR20 EXTEND a Patients with <20% improvement from baseline in either SJC or TJC for 2 consecutive assessments were eligible for rescue at week 12 with open-label sarilumab 200 mg q2w in the long-term safety study EXTEND. csdmards: methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine. csdmard, conventional synthetic disease-modifying antirheumatic drug; EP, endpoint; HAQ-DI, Health Assessment Questionnaire Disability Index; q2w, every 2 weeks; SJC, swollen joint count; TJC, tender joint count; TNF, tumor necrosis factor. 4
5 TARGET Inclusion and Exclusion Criteria Inclusion criteria DX of RA 6 months by ACR/EULAR criteria Prior anti-tnf therapy failure and/or intolerance to 1 anti-tnf drug (defined by the investigator) Active disease, defined as 6 of 66 swollen joints and 8 of 68 tender joints hs-crp 8 mg/l at screening Continuous treatment for 12 weeks before BL with 1 csdmards (stable dose for 6 weeks before screening) MTX: mg/week or per local labeling requirements, if the dose range differs Leflunomide: mg daily Sulfasalazine: mg daily Hydroxychloroquine: mg daily Key exclusion criteria Rx with anti-tnf agents within ~5 half-lives Prior treatment with any cell-depleting agents unless normal lymphocyte and CD 19+ lymphocyte count Prior treatment with anti IL-6 or anti IL-6 receptor antagonist therapies Oral glucocorticoid > prednisone 10 mg per day or equivalent per day, or a change in dosage within 4 weeks before randomization Any parenteral or intra-articular glucocorticoid injection within 4 weeks before baseline Active infection BL, baseline; csdmard, conventional synthetic disease-modifying antirheumatic drug; EULAR, European League Against Rheumatism; hs-crp, high-sensitivity C-reactive protein; IL-6, interleukin 6; MTX, methotrexate; RA, rheumatoid arthritis; TNF, tumor necrosis factor. 5
6 TARGET: Primary and Main Secondary Efficacy Endpoints Coprimary efficacy endpoints ACR20 response at week 24 Change from baseline in HAQ-DI at week 12 Secondary efficacy endpoints Change from baseline in DAS28-CRP at week 24 ACR50/70 at week 24 DAS28-CRP <2.6 at week 24 Change from baseline in CDAI at week 24 Change from baseline in HAQ-DI at week 24 Other secondary endpoints SF-36 at week 24; FACIT Fatigue at week 24; Morning stiffness at week 24; WPS-RA at week 24; RAID at week 24; EQ-5D-3L at week 24 CDAI, clinical disease activity index; DAS28-CRP, disease activity score in 28 joints using C-reactive protein; FACIT, Functional Assessment of Chronic Illness Therapy; HAQ-DI, Health Assessment Questionnaire Disability Index; RAID, Rheumatoid Arthritis Impact of Disease; SF-36, Short-Form-36; WPS-RA, Work Productivity Survey Rheumatoid Arthritis. 6
7 Baseline Demographics and Disease Activity Placebo + csdmard Sarilumab 150 mg q2w + csdmard Sarilumab 200 mg q2w + csdmard (n=184) Age, mean, y Female, % Caucasian, % Region, % Region Region Region RA duration, mean, y >1 prior anti-tnfs, % RF positive, % Anti-CCP antibody positive, % Tender joint count (68 assessed), mean Swollen joint count (66 assessed), mean CRP, mean, mg/l HAQ-DI (0-3), mean DAS28-CRP, mean CCP, citrullinated peptide antibody; CRP, C-reactive protein; csdmard, conventional synthetic disease-modifying antirheumatic drug; DAS28-CRP, disease activity score in 28 joints using CRP; HAQ-DI, Health Assessment Questionnaire Disability Index; q2w, every 2 weeks; RA, rheumatoid arthritis; RF, rheumatoid factor; TNF, tumor necrosis factor. Region 1: Australia, Canada, Czech Republic, Germany, Greece, Hungary, Israel, Italy, New Zealand, Portugal, Spain, United States. Region 2: Argentina, Brazil, Chile, Colombia, Ecuador, Guatemala, Mexico, Peru. Region 3: Lithuania, Poland, Russia, South Korea, Taiwan, Thailand, Turkey, Ukraine. 7
8 TARGET Patient Disposition Screened (n=1224) Randomized (n=546) Placebo n=181 patients Sarilumab 150 mg q2w n=181 patients Sarilumab 200 mg q2w n=184 patients 17 discontinued - 9 AE - 5 lack of efficacy - 1 poor compliance - 2 other reasons 31 discontinued - 18 AE - 4 lack of efficacy - 2 poor compliance - 7 other reasons 25 discontinued - 17 AE - 2 lack of efficacy - 1 poor compliance - 5 other reasons 63 rescued 25 rescued 26 rescued 101 patients completed the study - 94 rolled over to EXTEND 125 patients completed the study rolled over to EXTEND 133 patients completed the study rolled over to EXTEND Efficacy population included the intent-to-treat population, which consisted of all randomized patients. Safety population included all randomized patients who received 1 dose of the study medication. AE, adverse event; q2w, every 2 weeks. 8
9 ACR response, % ACR response, % ACR response, % ACR20/50/70 Responses at Week ACR20 Primary EP 100 ACR ACR * * * * *P< P= P= vs placebo + csdmard. Placebo + csdmard Sarilumab 150 mg q2w + csdmard Sarilumab 200 mg q2w + csdmard (n=184) csdmards: methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine. Data analyzed by and evaluated using the 2-sided Cochran-Mantel-Haenszel test stratified by prior biologic use and region. Patients are considered nonresponders from the time they started rescue medication or discontinued study medication. csdmard, conventional synthetic diseasemodifying antirheumatic drug; q2w, every 2 wks. 9
10 Mean change from baseline Improvement in HAQ-DI Scores at Week * Placebo + csdmard Sarilumab 150 mg q2w + csdmard Sarilumab 200 mg q2w + csdmard (n=184) *P= P= vs placebo + csdmard. csdmards: methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine. Data analyzed using a mixed model for repeated measures, which includes baseline, treatment, number of previous anti-tnfs, region, visit, and treatment-by-visit interaction. csdmard, conventional synthetic disease-modifying antirheumatic drug; HAQ-DI, Health Assessment Questionnaire Disability Index; q2w, every 2 weeks. 10
11 Change from baseline, mean Proportion of patients, % Change from baseline, mean Change from baseline, mean TARGET Selected Secondary Endpoints: CDAI, DAS28-CRP, HAQ-DI From Baseline to Week BL CDAI BL DAS28- CRP n=172 n=164 n=170 n=100 n=127 n= n=168 n=163 n=169 n=99 n=126 n= BL HAQ-DI n=170 n=165 n=171 n=101 n=127 n=136 DAS28-CRP <2.6 and 2.6 DAS28-CRP CDAI, clinical disease activity index; DAS28-CRP, disease activity score in 28 joints using C-reactive protein; HAQ-DI, Health Assessment Questionnaire Disability Index; q2w, every 2 weeks DAS28-CRP 3.2 DAS28-CRP <2.6 11
12 Overview of Safety Patients, n (%) Placebo + csdmard Sarilumab + csdmard 150 mg q2w 200 mg q2w (n=184) TEAE 90 (49.7) 119 (65.7) 120 (65.2) Treatment-emergent SAE, n (%) 6 (3.3) 6 (3.3) 10 (5.4) SIE, n (%) 2 (1.1) 1 (0.6) 2 (1.1) TEAE leading to death, n (%) 1 (0.6) a 0 0 Treatment discontinuation due to TEAE, n (%) 8 (4.4) 14 (7.7) 17 (9.2) csdmards: methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine. csdmard, conventional synthetic disease-modifying antirheumatic drug; q2w, every 2 weeks; SAE; serious adverse event; SIE, serious infectious event; TEAE, treatment-emergent adverse event. n (%) is the number and percentage of patients with at least 1 TEAE. a One death in the placebo group was a result of a motor vehicle accident. 12
13 Most Frequently Reported TEAEs ( 5%) Frequent TEAEs by SOC, n (%) Placebo + csdmard Sarilumab + csdmard 150 mg q2w 200 mg q2w (n=184) All TEAEs 90 (49.7) 119 (65.7) 120 (65.2) Infections and infestations 48 (26.5) 40 (22.1) 56 (30.4) Urinary tract infection 12 (6.6) 6 (3.3) 13 (7.1) Nasopharyngitis 9 (5.0) 11 (6.1) 7 (3.8) Blood and lymphatic system disorders 9 (5.0) 25 (13.8) 29 (15.8) Neutropenia 2 (1.1) 23 (12.7) 23 (12.5) Metabolism and nutrition disorders 7 (3.9) 21 (11.6) 15 (8.2) Hypertriglyceridemia 3 (1.7) 11 (6.1) 5 (2.7) Administration site conditions 10 (5.5) 24 (13.3) 22 (12.0) Injection site erythema 0 11 (6.1) 7 (3.8) Investigations 8 (4.4) 19 (10.5) 30 (16.3) ALT increased 2 (1.1) 5 (2.8) 10 (5.4) csdmards: methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine. ALT, alanine aminotransferase; csdmard, conventional synthetic disease-modifying antirheumatic drug; q2w, every 2 weeks; SOC, system organ class. TEAE: treatment-emergent adverse event reported by investigators. 13
14 Laboratory Abnormalities Through Week 24 Patients, n (%) Absolute neutrophil count Placebo + csdmard Sarilumab + csdmard 150 mg q2w 200 mg q2w (n=184) 0.5 to 1.0 Giga/L (grade 3) 1 (0.6) 10 (5.5) 16 (8.7) <0.5 Giga/L (grade 4) 0 4 (2.2) 2 (1.1) Alanine aminotransferase >ULN to 3 ULN 46 (25.4) 76 (42.0) 80 (43.5) >3 ULN to 5 ULN 2 (1.1) 4 (2.2) 7 (3.8) >5 ULN Platelet count 50 to 100 Giga/L (2.7) <50 Giga/L (0.5) csdmard, conventional synthetic disease-modifying antirheumatic drug; HDL, high-density lipoprotein; LDL, low-density lipoprotein; q2w, every 2 weeks; ULN, upper limit of normal. 14
15 Improvements in Laboratory Parameters at Week 24 Sarilumab + csdmard Laboratory parameters Placebo + csdmard 150 mg q2w 200 mg q2w (n=184) Hemoglobin, mean change from BL, g/l Patients with AE of anemia, n (%) 5 (2.8) 0 1 (0.5) CRP, mean change from BL, mg/l Albumin, mean change from BL, g/l csdmards: methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine. AE, adverse event; BL, baseline; CRP, C-reactive protein; csdmard, conventional synthetic disease-modifying antirheumatic drug; q2w, every 2 weeks. 15
16 Conclusions Sarilumab 150 and 200 mg q2w + csdmard demonstrated clinical efficacy and improvement in physical function versus placebo + csdmard in patients with active RA who were inadequate responders to or intolerant of anti-tnfs TEAEs leading to treatment discontinuation and SAEs (200 mg only) were more frequent in the sarilumab-treated groups compared with placebo each with concomitant csdmard Serious infections were infrequent, and the incidence was similar between sarilumab-treated and placebo groups Adverse events and laboratory changes were consistent with IL-6 blockade and observations from the MOBILITY study Neutropenia was among the most frequent TEAEs in the sarilumab + csdmard treatment groups csdmard, conventional synthetic disease-modifying antirheumatic drug; IL-6, interleukin 6; q2w, every 2 weeks; RA, rheumatoid arthritis; SAE, serious adverse event; TEAE, treatment-emergent adverse event; TNF, tumor necrosis factor. 16
17 Acknowledgments The authors would like to thank the patients and investigators whose participation and contributions made this study possible The authors acknowledge Kristi Porter, PhD (MedThink SciCom), whose work was funded by Sanofi and Regeneron Pharmaceuticals, Inc, for medical writing assistance with this presentation 17
18 Backup Slides 18
19 Mean change from baseline Mean change from baseline HAQ-DI at Week 12 0 ITT population (n=546) 0 By geographic region Region 1 (n=208) Region 2 (n=209) Region 3 (n=89) *P= **P= vs placebo + csdmards Placebo + csdmard Region 2 had a placebo response greater than the mcid at week 12, but the treatment benefit with sarilumab was consistent across all regions Sarilumab 150 mg q2w + csdmard P value for interaction = Sarilumab 200 mg q2w + csdmard (n=184) Change from baseline in HAQ-DI at week 12 was analyzed using a mixed model for repeated measures adjusted for prior biologic use, region, and baseline HAQ-DI score as covariate. csdmard, non-biologic disease-modifying antirheumatic drug; HAQ-DI, Health Assessment Questionnaire Disability Index; ITT, intent-to-treat; mcid, minimally clinically important difference; q2w, every 2 weeks. 19
20 HAQ-DI response, % HAQ-DI response, % HAQ-DI Responders at Week HAQ-DI improvement * *P= P< vs placebo + csdmard HAQ-DI improvement 0.30 * *P= P= vs placebo + csdmard Placebo + csdmard Sarilumab 150 mg q2w + csdmard Sarilumab 200 mg q2w + csdmard (n=184) csdmards: methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine. csdmard, conventional synthetic disease-modifying antirheumatic drug; HAQ-DI, Health Assessment Questionnaire Disability Index; q2w, every 2 weeks. 20
21 Number (%) of Patients With TEAEs of Special Interest a Placebo + Sarilumab + csdmard TEAEs of special interest (MedDRA PT level), n (%) csdmard 150 mg q2w 200 mg q2w (n=184) Infections 48 (26.5) 40 (22.1) 56 (30.4) Serious infections 2 (1.1) 1 (0.6) 2 (1.1) Herpes Zoster 1 (0.6) 0 2 (1.1) Tuberculosis Leukopenia 3 (1.7) 26 (14.4) 26 (14.1) Thrombocytopenia 0 1 (0.6) 5 (2.7) Hepatic disorders b 4 (2.2) 8 (4.4) 19 (10.3) Diverticulitis/Potential GI perforations GI ulcerations 0 1 (0.6) 0 Elevations in lipids 5 (2.8) 21 (11.6) 15 (8.2) Hypersensitivity 7 (3.9) 10 (5.5) 11 (6.0) Anaphylaxis Injection site reactions 2 (1.1) 13 (7.2) 15 (8.2) Malignancy 1 (0.6) 1 (0.6) 1 (0.5) Malignancy excluding NMSC 1 (0.6) 1 (0.6) 0 Lupus-like syndrome Demyelinating disorders csdmards: methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine. csdmard, conventional synthetic disease-modifying antirheumatic drug; GI, gastrointestinal; MedDRA, Medical Dictionary of Regulatory Activities; NMSC, nonmetastatic squamous cell; PT, preferred term; q2w, every 2 weeks; TEAE, treatment-emergent adverse event. a TEAEs of special interest as reported by investigator. b Hepatic disorders were generally nonserious elevations in transaminases. 21
22 Serious Adverse Events by Primary System Organ Class and Preferred Term Safety Population (I) Placebo Sarilumab + csdmard Serious adverse events, n (%) a + csdmard (N=181) 150 mg q2w (N=181) 200 mg q2w (N=184) Any class 6 (3.3) 6 (3.3) 10 (5.4) Infections and infestations 2 (1.1) 1 (0.6) 2 (1.1) Cellulitis 1 (0.6) 1 (0.6) 1 (0.5) Pneumonia (0.5) Bacteremia 1 (0.6) 0 0 Bronchitis 1 (0.6) 0 0 Osteomyelitis 0 1 (0.6) 0 Neoplasms benign, malignant and unspecified (including cysts and polyps) 1 (0.6) 0 0 Ureteric cancer 1 (0.6) 0 0 Blood and lymphatic system disorders 1 (0.6) 1 (0.6) 1 (0.5) Neutropenia 0 1 (0.6) 1 (0.5) Anemia 1 (0.6) 0 0 Nervous system disorders 0 1 (0.6) 1 (0.5) Ischemic stroke (0.5) Syncope 0 1 (0.6) 0 Cardiac disorders (1.1) Acute myocardial infarction (0.5) Atrioventricular block second degree (0.5) Endocarditis noninfective (0.5) csdmards: methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine. csdmard, conventional synthetic disease-modifying antirheumatic drug; q2w, every 2 weeks. a SAEs, treatment-emergent serious adverse events as reported by investigator. 22
23 Serious Adverse Events by Primary System Organ Class and Preferred Term Safety Population (II) Placebo Sarilumab + csdmard Serious adverse events, n (%) a + csdmard (N=181) 150 mg q2w (N=181) 200 mg q2w (N=184) Vascular disorders (0.5) Venous thrombosis limb (0.5) Respiratory, thoracic and mediastinal disorders 0 1 (0.6) 0 Pulmonary embolism 0 1 (0.6) 0 Gastrointestinal disorders 0 1 (0.6) 1 (0.5) Inguinal hernia (0.5) Gastric ulcer hemorrhage 0 1 (0.6) 0 Hepatobiliary disorders 1 (0.6) 0 0 Mixed liver injury 1 (0.6) 0 0 Musculoskeletal and connective tissue disorders 1 (0.6) 1 (0.6) 1 (0.5) Intervertebral disc disorder (0.5) Intervertebral disc protrusion 0 1 (0.6) 0 Rheumatoid arthritis 1 (0.6) 0 0 Investigations (1.1) Neutrophil count decreased (0.5) Transaminases increased (0.5) Injury, poisoning and procedural complications 2 (1.1) 0 1 (0.5) Post-procedural hemorrhage (0.5) Ankle fracture 1 (0.6) 0 0 Road traffic accident 1 (0.6) 0 0 csdmards: methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine. csdmard, conventional synthetic disease-modifying antirheumatic drug; q2w, every 2 weeks. a SAEs, treatment-emergent serious adverse events as reported by investigator. 23
24 Laboratory Abnormalities Through Week 24 Patients, n (%) Total cholesterol Placebo + csdmard Sarilumab + csdmard 150 mg q2w 200 mg q2w (n=184) 6.2 mmol/l (239 mg/dl) 44/181 (24.3) 83/180 (46.1) 81/182 (44.5) 7.74 mmol/l (299 mg/dl) 7/181 (3.9) 20/180 (11.1) 23/182 (12.6) LDL 4.1 mmol/l (158 mg/dl) 27/181 (14.9) 56/179 (31.3) 58/182 (31.9) 4.9 mmol/l (189 mg/dl) 11/181 (6.1) 19/179 (10.6) 28/182 (15.4) Triglycerides 4.6 mmol/l (407 mg/dl) 2/181 (1.1) 13/180 (7.2) 8/182 (4.4) 5.6 mmol/l (496 mg/dl) 1/181 (0.6) 11/180 (6.1) 5/182 (2.7) Lipid levels, no./total (%) Increase in LDL-C from <160 mg/dl to 160 mg/dl a 16/169 (9.5) 48/170 (28.2) 44/172 (25.6) Increase in HDL-C from <60 mg/dl to 60 mg/dl b 32/109 (29.4) 42/106 (39.6) 38/105 (36.2) Statins were initiated in 7 (3.9%) patients in the sarilumab 150 mg q2w group and 8 (4.3%) patients in the sarilumab 200 mg q2w group during the study. No patient in the placebo group initiated statins during the study. csdmard, conventional synthetic disease-modifying antirheumatic drug; HDL, high-density lipoprotein; LDL, low-density lipoprotein; q2w, every 2 weeks; ULN, upper limit of normal. asample size: placebo + csdmard, n=169; sarilumab 150 mg + csdmard, n=170; sarilumab 200 mg + csdmard, n=172. bsample size: placebo + csdmard, n=109; sarilumab 150 mg + csdmard, n=106; sarilumab 200 mg + csdmard, n=
25 Mean hemoglobin, g/ml Increase in Hemoglobin Over Time in the Safety Population Placebo + csdmard Sarilumab 150 mg q2w + csdmard Sarilumab 200 mg q2w + csdmard BL Week csdmard, conventional synthetic disease-modifying antirheumatic drug; q2w, every 2 weeks. 25
26 Mean albumin, g/l Increase in Albumin Over Time in the Safety Population Placebo + csdmard Sarilumab 150 mg q2w + csdmard Sarilumab 200 mg q2w + csdmard BL Week csdmard, conventional synthetic disease-modifying antirheumatic drug; q2w, every 2 weeks. 26
27 Mean HDL, mmol/l Mean triglycerides, mmol/l Mean cholesterol, mmol/l Mean LDL, mmol/l Mean Total Cholesterol, HDL, LDL, and Total Triglycerides During the TEAE Period in the Safety Population Mean cholesterol Mean LDL BL Week 2.6 BL Week Mean HDL Mean triglycerides BL Week 1.35 BL Week csdmard, conventional synthetic disease-modifying antirheumatic drug; HDL, high-density lipoprotein; LDL, low-density lipoprotein; q2w, every 2 weeks; TEAE, treatment-emergent adverse event. 27
28 Number (%) of Patients With TEAEs by Primary SOC and PT ( 2% in at Least 1 Treatment Group) Placebo Sarilumab + csdmard TEAE, n (%) + csdmard (N=181) 150 mg q2w (N=181) 200 mg q2w (N=184) Any class 90 (49.7) 119 (65.7) 120 (65.2) Infections and infestations 48 (26.5) 40 (22.1) 56 (30.4) Urinary tract infection 12 (6.6) 6 (3.3) 13 (7.1) Nasopharyngitis 9 (5.0) 11 (6.1) 7 (3.8) Pharyngitis 3 (1.7) 2 (1.1) 6 (3.3) Upper respiratory tract infection 6 (3.3) 4 (2.2) 6 (3.3) Influenza 2 (1.1) 2 (1.1) 5 (2.7) Sinusitis 4 (2.2) 3 (1.7) 5 (2.7) Gastroenteritis 3 (1.7) 2 (1.1) 4 (2.2) Cellulitis 1 (0.6) 3 (1.7) 3 (1.6) Oral herpes (1.6) Pneumonia 0 2 (1.1) 3 (1.6) Conjunctivitis 2 (1.1) 0 2 (1.1) Fungal skin infection (1.1) Rhinitis 2 (1.1) 1 (0.6) 0 Blood and lymphatic system disorders 9 (5.0) 25 (13.8) 29 (15.8) Neutopenia 2 (1.1) 23 (12.7) 23 (12.5) Thrombocytopenia (2.7) Leukopenia 0 2 (1.1) 3 (1.6) Anemia 5 (2.8) 0 1 (0.5) csdmard, conventional synthetic disease-modifying antirheumatic drug; PT, preferred term; q2w, every 2 weeks; SOC, system organ class; TEAE, treatment-emergent adverse event. 28
29 Number (%) of Patients With TEAEs by Primary SOC and PT ( 2% in at Least 1 Treatment Group) (cont) Placebo Sarilumab + csdmard TEAE, n (%) + csdmard (N=181) 150 mg q2w (N=181) 200 mg q2w (N=184) Metabolism and nutrition disorders 7 (3.9) 21 (11.6) 15 (8.2) Hypertriglyceridemia 3 (1.7) 11 ( 6.1) 5 (2.7) Hypercholesterolemia 0 6 (3.3) 4 (2.2) Hyperlipidemia 1 (0.6) 2 (1.1) 3 (1.6) Dyslipidemia 0 4 (2.2) 2 (1.1) Hypokalemia (1.1) Nervous system disorders 15 (8.3) 12 (6.6) 10 (5.4) Headache 7 (3.9) 5 (2.8) 6 (3.3) Dizziness 4 (2.2) 2 (1.1) 2 (1.1) Convulsion 0 2 (1.1) 0 Paresthesia 0 2 (1.1) 0 Eye disorders 1 (0.6) 5 (2.8) 4 (2.2) Cataract 0 1 (0.6) 2 (1.1) Vascular disorders 8 (4.4) 4 (2.2) 10 (5.4) Hypertension 4 (2.2) 3 (1.7) 8 (4.3) Hot flush 2 (1.1) 0 1 (0.5) Respiratory, thoracic and mediastinal disorders 7 (3.9) 8 (4.4) 13 (7.1) Rhinitis allergic (1.1) Sinus congestion 2 (1.1) 0 1 (0.5) Gastrointestinal disorders 16 (8.8) 10 (5.5) 26 (14.1) Diarrhea 7 (3.9) 2 (1.1) 6 (3.3) Abdominal distension (1.6) Aphthous stomatitis 1 (0.6) 0 3 (1.6) Abdominal discomfort (1.1) Food poisoning (1.1) Gastritis 0 2 (1.1) 2 (1.1) Mouth ulceration (1.1) Nausea 3 (1.7) 1 (0.6) 2 (1.1) Abdominal pain 1 (0.6) 3 (1.7) 0 Hemorrhoids 2 (1.1) 0 0 Hepatobiliary disorders 1 (0.6) 1 (0.6) 4 (2.2) Hepatic steatosis (1.1) Skin and subcutaneous tissue disorders 11 (6.1) 15 (8.3) 11 (6.0) Pruritus generalized 0 1 (0.6) 3 (1.6) Pruritus 0 3 (1.7) 1 (0.5) Dermatitis allergic 0 2 (1.1) 0 Erythema 0 3 (1.7) 0 csdmard, conventional synthetic disease-modifying antirheumatic drug; PT, preferred term; q2w, every 2 weeks; SOC, system organ class; TEAE, treatmentemergent adverse event. 29
30 Number (%) of Patients With TEAEs by Primary SOC and PT ( 2% in at Least 1 Treatment Group) (cont) Placebo Sarilumab + csdmard TEAE, n (%) + csdmard (N=181) 150 mg q2w (N=181) 200 mg q2w (N=184) Musculoskeletal and connective tissue disorders 22 (12.2) 18 (9.9) 15 (8.2) Rheumatoid arthritis 8 (4.4) 3 (1.7) 4 (2.2) Back pain 1 (0.6) 2 (1.1) 3 (1.6) Arthralgia 0 1 (0.6) 2 (1.1) Musculoskeletal pain 0 1 (0.6) 2 (1.1) Bursitis 2 (1.1) 0 1 (0.5) Intervertebral disc protrusion 0 3 (1.7) 0 Joint swelling 2 (1.1) 1 (0.6) 0 Muscle spasms 3 (1.7) 1 (0.6) 0 Pain in extremity 3 (1.7) 1 (0.6) 0 Renal and urinary disorders 3 (1.7) 3 (1.7) 0 Hematuria 0 2 (1.1) 0 Nephrolithiasis 0 2 (1.1) 0 Reproductive system and breast disorders 5 (2.8) 3 (1.7) 1 (0.5) Metrorrhagia 2 (1.1) 0 0 General disorders and administration site conditions 10 (5.5) 24 (13.3) 22 (12.0) Injection site erythema 0 11 (6.1) 7 (3.8) Injection site pruritus 0 4 (2.2) 5 (2.7) Injection site rash 1 (0.6) 1 (0.6) 3 (1.6) Edema peripheral 1 (0.6) 3 (1.7) 3 (1.6) Pyrexia 0 1 (0.6) 2 (1.1) Investigations 8 (4.4) 19 (10.5) 30 (16.3) Alanine aminotransferase increased 2 (1.1) 5 (2.8) 10 (5.4) Aspartate aminotransferase increased 0 2 (1.1) 6 (3.3) Transaminases increased 0 2 (1.1) 3 (1.6) Blood pressure increased 0 1 (0.6) 2 (1.1) Hepatic enzyme increased (1.1) Neutrophil count decreased 0 3 (1.7) 2 (1.1) Blood triglycerides increased 0 2 (1.1) 1 (0.5) Injury, poisoning and procedural complications 15 (8.3) 16 (8.8) 15 (8.2) Accidental overdose 5 (2.8) 7 (3.9) 9 (4.9) Arthropod bite 0 2 (1.1) 0 Fall 3 (1.7) 1 (0.6) 0 Ligament sprain 0 2 (1.1) 0 csdmard, conventional synthetic disease-modifying antirheumatic drug; PT, preferred term; q2w, every 2 weeks; SOC, system organ class; TEAE, treatmentemergent adverse event. 30
Charité - University Hospital, Free University and Humboldt University of Berlin, Berlin, Germany; 2 Sanofi Genzyme, Bridgewater, NJ, USA; 3
Efficacy and Safety of Sarilumab Versus Adalimumab in a Phase 3, Randomized, Double-blind, Monotherapy Study in Patients With Active Rheumatoid Arthritis With Intolerance or Inadequate Response to Methotrexate
More informationNew Evidence reports on presentations given at EULAR Safety and Efficacy of Tocilizumab as Monotherapy and in Combination with Methotrexate
New Evidence reports on presentations given at EULAR 2009 Safety and Efficacy of Tocilizumab as Monotherapy and in Combination with Methotrexate Report on EULAR 2009 presentations Tocilizumab inhibits
More informationWARNING: RISK OF SERIOUS INFECTIONS
RA PROGRESSION INTERRUPTED 1 DOSAGE AND ADMINISTRATION GUIDE No structural damage progression was observed at week 52 in 55.6% and in 47.8% of patients receiving KEVZARA 200 mg + MTX or 150 mg + MTX, compared
More informationSynopsis Style Clinical Study Report SAR ACT sarilumab Version number : 1 (electronic 1.0)
SYNOPSIS Title of the study: A randomized, double-blind, parallel-group, placebo- and active calibrator-controlled study assessing the clinical benefit of SAR153191 subcutaneous (SC) on top of methotrexate
More information2.0 Synopsis. Adalimumab (HUMIRA ) W Clinical Study Report R&D/15/0629. Individual Study Table Referring to Part of Dossier: Volume:
2.0 Synopsis AbbVie Inc. Name of Study Drug: Adalimumab / HUMIRA Name of Active Ingredient: Adalimumab Individual Study Table Referring to Part of Dossier: Volume: Page: (For National Authority Use Only)
More informationIndividual Study Table Referring to Part of Dossier: Use Only) Name of Study Drug:
2.0 Synopsis AbbVie Inc. Individual Study Table Referring to Part of Dossier: (For National Authority Use Only) Name of Study Drug: Volume: Adalimumab (Humira ) Page: Name of Active Ingredient: Adalimumab
More informationWARNING: RISK OF SERIOUS INFECTIONS
DOSAGE AND ADMINISTRATION GUIDE RA PROGRESSION INTERRUPTED 1 No structural damage progression was observed at week 52 in 55.6% and in 47.8% of patients receiving KEVZARA 200 mg + MTX or 150 mg + MTX, compared
More informationYoshiya Tanaka 1*, Kazuteru Wada 2, Yoshinori Takahashi 2, Owen Hagino 3, Hubert van Hoogstraten 4, Neil M. H. Graham 5 and Hideto Kameda 6
Tanaka et al. Arthritis Research & Therapy (2019) 21:79 https://doi.org/10.1186/s13075-019-1856-4 RESEARCH Open Access Sarilumab plus methotrexate in patients with active rheumatoid arthritis and inadequate
More informationClinicalTrials.gov Protocol Registration and Results System (PRS) Receipt Release Date: 01/19/2016. ClinicalTrials.gov ID: NCT
ClinicalTrials.gov Protocol Registration and Results System (PRS) Receipt Release Date: 01/19/2016 ClinicalTrials.gov ID: NCT00595413 Study Identification Unique Protocol ID: 27905 Brief Title: Atacicept
More informationEXECUTIVE SUMMARY. Date of Report: 25-Mar Database as of: 05-Mar-2008
EXECUTIVE SUMMARY Date of Report: 25-Mar-2008 Database as of: 05-Mar-2008 Title of Study: Protocol : A Phase II, Multi-center, Randomized, Double-Blind, Placebo Controlled, Dose-Response Study to Evaluate
More information10/28/2013. Disclosures. Objectives. Background. Study Design. Key Inclusion Criteria
Randomization (1:1:1:1) /28/13 Tocilizumab in Combination Therapy and Monotherapy Versus Methotrexate in Methotrexate-Naive Patients With Early Rheumatoid Arthritis: Clinical and Radiographic Outcomes
More information2.0 Synopsis. Adalimumab M Clinical Study Report Final R&D/15/1093. (For National Authority Use Only)
2.0 Synopsis AbbVie Inc. Name of Study Drug: Adalimumab Name of Active Ingredient: Adalimumab Individual Study Table Referring to Part of Dossier: Volume: Page: (For National Authority Use Only) Title
More informationUniversity of California, San Diego, School of Medicine, La Jolla, CA, USA; 2
2194 Long-term (104-Week) Efficacy and Safety Profile of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, in Patients With Psoriatic Arthritis: Results From a Phase III, Randomized, Controlled Trial
More informationKevzara (sarilumab) NEW PRODUCT SLIDESHOW
Kevzara (sarilumab) NEW PRODUCT SLIDESHOW Introduction Brand name: Kevzara Generic name: Sarilumab Pharmacological class: Interleukin-6 antagonist Strength and Formulation: 150mg/1.14mL, 200mg/1.14mL;
More informationIndustry Relationships and Institutional Affiliations
Efficacy and safety of alirocumab in high cardiovascular risk patients with inadequately controlled hypercholesterolaemia on maximally tolerated daily statin: results from the ODYSSEY COMBO II study Christopher
More informationSYNOPSIS. Clinical Study Report IM Double-blind Period
Name of Sponsor/Company: Bristol-Myers Squibb Name of Finished Product: Abatacept () Name of Active Ingredient: Abatacept () Individual Study Table Referring to the Dossier SYNOPSIS (For National Authority
More informationSponsor Novartis. Generic Drug Name Vildagliptin/Metformin. Therapeutic Area of Trial Type 2 diabetes. Approved Indication Type 2 diabetes
Clinical Trial Results Database Page 1 Sponsor Novartis Generic Drug Name Vildagliptin/Metformin Therapeutic Area of Trial Type 2 diabetes Approved Indication Type 2 diabetes Study Number CLMF237A2309
More informationgolimumab Principal Investigator(s): Principal Investigator: Michael E. Weinblatt, MD Brigham and Women s
Module 5.3.5.1 Rheumatoid Arthritis IV (24-Week submission) 24-Week CNTO148ART3001Clinical Study Report SYNOPSIS Issue Date: 07 Nov 2011 Document No.: EDMS-ERI-22836553 Name of Sponsor/Company Name of
More informationStudy synopsis of the global non-interventional study SWITCH-RA
Study synopsis of the global non-interventional study SWITCH-RA Protocol number: MA22401 Title of Study: A global multi-centre observational study in RA patients who are non-responders or intolerant to
More informationEfficacy and Safety of Tocilizumab in the Treatment of Rheumatoid Arthritis and Juvenile Idiopathic Arthritis
New Evidence reports on presentations given at EULAR 2010 Efficacy and Safety of Tocilizumab in the Treatment of Rheumatoid Arthritis and Juvenile Idiopathic Arthritis Report on EULAR 2010 presentations
More informationPFIZER INC. These results are supplied for informational purposes only.
PFIZER INC. These results are supplied for informational purposes only. COMPOUND NUMBER: PF-05212374 PROTOCOL NO.: 3206K1-2203 (B2051001) PROTOCOL TITLE: A Randomized, Parallel, Double-Blind, Placebo-Controlled
More information2.0 Synopsis. Adalimumab DE019 OLE (5-year) Clinical Study Report Amendment 1 R&D/06/095. (For National Authority Use Only)
2.0 Synopsis Abbott Laboratories Name of Study Drug: Humira Name of Active Ingredient: Adalimumab Individual Study Table Referring to Part of Dossier: Volume: Page: (For National Authority Use Only) Title
More informationKenneth W. Mahaffey, MD and Keith AA Fox, MB ChB
Once-daily oral direct factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation Kenneth W. Mahaffey, MD and Keith AA Fox, MB ChB on behalf
More informationSYNOPSIS 2/198 CSR_BDY-EFC5825-EN-E02. Name of company: TABULAR FORMAT (For National Authority Use only)
SYNOPSIS Title of the study: A randomized, double-blind, placebo-controlled, parallel-group, fixed-dose (rimonabant 20 mg) multicenter study of long-term glycemic control with rimonabant in treatment-naïve
More informationSupplementary Online Content
Supplementary Online Content Chawla SP, Papai Z, Mukhametshina G, et al. First-line aldoxorubicin vs doxorubicin in metastatic or locally advanced unresectable soft-tissue sarcoma: a phase 2b randomized
More informationEfficacy Study of Zoledronic Acid and Teriparatide Combination Therapy in Women With Osteoporosis
A service of the U.S. National Institutes of Health Trial record 1 of 1 for: CZOL446H2409 Previous Study Return to List Next Study Efficacy Study of Zoledronic Acid and Combination Therapy in Women With
More informationEarly and late responses to tocilizumab in RA / T. Dörner et al. SUPPLEMENTARY APPENDIX. Supplementary appendix 1: Selection criteria
SUPPLEMENTARY APPENDIX Supplementary appendix 1: Selection criteria Inclusion criteria included Active rheumatoid arthritis (RA) of 6 months duration at baseline, Disease Activity Score using 28 joints
More informationFull Novartis CTRD Results Template
Full Novartis CTRD Results Template Sponsor Novartis Generic Drug Name vildagliptin Therapeutic Area of Trial Type 2 diabetes Approved Indication Type 2 diabetes Protocol Number CLAF237A23138E1 Title A
More informationPRODUCT MONOGRAPH. Pr XELJANZ. tofacitinib, tablets, oral 5 mg tofacitinib (as tofacitinib citrate) 10 mg tofacitinib (as tofacitinib citrate)
PRODUCT MONOGRAPH Pr XELJANZ tofacitinib, tablets, oral 5 mg tofacitinib (as tofacitinib citrate) 10 mg tofacitinib (as tofacitinib citrate) XELJANZ XR tofacitinib extended-release, tablets, oral 11 mg
More informationPFIZER INC. These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert.
PFIZER INC. These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert. PROPRIETARY DRUG NAME / GENERIC DRUG NAME: Caduet / Amlodipine
More informationSupplementary Online Content
Supplementary Online Content Lind M, Polonsky W, Hirsch IB, et al. Effect of continuous glucose monitoring vs conventional therapy on glycemic control among patients type 1 diabetes treated multiple daily
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationLong-term safety, tolerability and efficacy of alirocumab in high cardiovascular risk patients: ODYSSEY LONG TERM
Long-term safety, tolerability and efficacy of alirocumab in high cardiovascular risk patients: ODYSSEY LONG TERM Efficacy by subgroup, and safety when LDL-C
More informationSynopsis. Adalimumab M Clinical Study Report R&D/09/060. (For National Authority Use Only) to Part of Dossier: Name of Study Drug:
Synopsis Abbott Laboratories Name of Study Drug: Individual Study Table Referring to Part of Dossier: Volume: (For National Authority Use Only) Name of Active Ingredient: Page: Title of Study: A Multi-Center,
More informationClinialTrials.gov Identifier: sanofi-aventis. Sponsor/company: 07/November/2008
These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription Sponsor/company: sanofi-aventis ClinialTrials.gov
More informationSponsor. Novartis. Generic Drug Name. Vildagliptin. Therapeutic Area of Trial. Type 2 diabetes. Approved Indication. Type 2 diabetes.
Sponsor Page 1 Novartis Generic Drug Name Vildagliptin Therapeutic Area of Trial Type 2 diabetes Approved Indication Type 2 diabetes Study Number CLAF237A2308 Title A multicenter, randomized, double-blind,
More informationAlirocumab Treatment Effect Did Not Differ Between Patients With and Without Low HDL-C or High Triglyceride Levels in Phase 3 trials
Alirocumab Treatment Effect Did Not Differ Between Patients With and Without Low HDL-C or High Triglyceride Levels in Phase 3 trials G. Kees Hovingh, 1 Richard Ceska, 2 Michael Louie, 3 Pascal Minini,
More informationRandomized Comparison of the Safety, Tolerability, and Efficacy of Long-term Administration of AMG 145: 52-Week Results From the OSLER Study
Randomized Comparison of the Safety, Tolerability, and Efficacy of Long-term Administration of AMG 145: 52-Week Results From the OSLER Study Michael J Koren 1, Robert P Giugliano 2, Frederick Raal 3, David
More informationSponsor Novartis. Generic Drug Name Pasireotide. Therapeutic Area of Trial Cushing s disease. Protocol Number CSOM230B2208E1
Sponsor Novartis Generic Drug Name Pasireotide Therapeutic Area of Trial Cushing s disease Protocol Number CSOM230B2208E1 Title Extension to a multicenter, open-label study to assess the safety and efficacy
More informationNilotinib AEs (adverse events) in CML population:
Nilotinib AEs (adverse events) in CML population: The percentages below were taken from a randomized trial of nilotinib 300mg BID in newly diagnosed Ph+ CML patients (N=279) taken from the Tasigna 2017
More informationABSTRACT ORIGINAL RESEARCH. Alan Kivitz. Thomas Wallace. Ewa Olech. Michael Borofsky. Jenny Devenport. Jinglan Pei. Margaret Michalska
Rheumatol Ther (2016) 3:291 304 DOI 10.1007/s40744-016-0043-1 ORIGINAL RESEARCH Long-Term Safety and Efficacy of Subcutaneously Administered Tocilizumab for Adult Rheumatoid Arthritis: A Multicenter Phase
More informationSponsor. Generic Drug Name. Trial Indications. Protocol Number. Protocol Title. Clinical Trial Phase. Study Start/End Dates. Reason for Termination
Sponsor Alcon Research, Ltd. Generic Drug Name Travoprost/timolol maleate Trial Indications Open-angle glaucoma or ocular hypertension Protocol Number C-09-007 Protocol Title An Evaluation of Patient Reported
More informationThe study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationAdalimumab M Clinical Study Report Final R&D/14/1263. Page:
Synopsis AbbVie Inc. Name of Study Drug: Adalimumab Name of Active Ingredient: Adalimumab Individual Study Table Referring to Part of Dossier: Volume: Page: (For National Authority Use Only) Title of Study:
More informationEfficacy and Safety of Alirocumab in Patients with Hypercholesterolemia not on Statin Therapy: the ODYSSEY CHOICE II Study
Efficacy and Safety of Alirocumab in Patients with Hypercholesterolemia not on Statin Therapy: the ODYSSEY CHOICE II Study Erik Stroes, 1 John Guyton, 2 Michel Farnier, 3 Norman Lepor, 4 Fernando Civeira,
More informationNew Evidence reports on presentations given at EULAR Tocilizumab for the Treatment of Rheumatoid Arthritis and Juvenile Idiopathic Arthritis
New Evidence reports on presentations given at EULAR 2011 Tocilizumab for the Treatment of Rheumatoid Arthritis and Juvenile Idiopathic Arthritis Report on EULAR 2011 presentations Benefit of continuing
More informationStudy No.: Title: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationSynopsis Style Clinical Study Report SR EFC10139 Version number: 1 (electronic 2.0)
SYNOPSIS Title of the study: A randomized, double-blind, parallel-group, multicenter, multinational study to assess the long-term effect, over 1 year, of rimonabant 10 mg in comparison with rimonabant
More informationClinical Trial Synopsis TL-OPI-525, NCT#
Clinical Trial Synopsis, NCT#00762736 Title of Study: A Phase II, Double-Blind, Randomized, Placebo-Controlled, Proof-of-Concept Study of the Efficacy, Safety, and Tolerability of Pioglitazone HCl (ACTOS
More informationACTEMRA (tocilizumab) injection, for intravenous use injection, for subcutaneous use Initial U.S. Approval: 2010
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ACTEMRA safely and effectively. See full prescribing information for ACTEMRA. ACTEMRA (tocilizumab)
More informationSupplemental Table 1. Key Inclusion Criteria Inclusion Criterion OPTIMA PREMIER 18 years old with RA (per 1987 revised American College of General
Supplemental Table 1. Key Inclusion Criteria Inclusion Criterion OPTIMA PREMIER 18 years old with RA (per 1987 revised American College of General Rheumatology classification criteria) 34 ; erythrocyte
More informationNew Evidence reports on presentations given at ACR Improving Radiographic, Clinical, and Patient-Reported Outcomes with Rituximab
New Evidence reports on presentations given at ACR 2009 Improving Radiographic, Clinical, and Patient-Reported Outcomes with Rituximab From ACR 2009: Rituximab Rituximab in combination with methotrexate
More informationLondon, 1 June 2006 Product name: REMICADE Procedure number: Remicade-H-240-II-73-AR SCIENTIFIC DISCUSSION 1/8
London, 1 June 2006 Product name: REMICADE Procedure number: Remicade-H-240-II-73-AR SCIENTIFIC DISCUSSION 1/8 1. Introduction Infliximab is a chimeric human-murine IgG1κ monoclonal antibody, which binds
More informationSecondary efficacy endpoints for Part 2, the Eltrombopag-Only Period, included the proportion of subjects who
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationThe study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationFull Novartis CTRD Results Template
Full Novartis CTRD Results Template Sponsor Novartis Generic Drug Name vildagliptin Therapeutic Area of Trial Type 2 diabetes Approved Indication Type 2 diabetes Protocol Number CLAF237A23137E1 Title A
More informationThe Medical Letter. on Drugs and Therapeutics
The Medical Letter publications are protected by US and international copyright laws. Forwarding, copying or any other distribution of this material is strictly prohibited. For further information call:
More informationACTEMRA Risk Mitigation Strategy Presenter Name, Degree
ACTEMRA Risk Mitigation Strategy Presenter Name, Degree Medical Science Liaison Genentech, Inc. 1 Indications and Dosage Rheumatoid Arthritis (RA) (1 of 2) Indication in RA ACTEMRA (tocilizumab) is indicated
More informationStudy Code: Date: 27 July 2007
These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription Sponsor/company: Generic drug name:
More informationPFIZER INC. These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert.
PFIZER INC. These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert. GENERIC DRUG NAME / COMPOUND NUMBER: Tofacitinib / CP-690,550
More informationAnnual Rheumatology & Therapeutics Review for Organizations & Societies
Annual Rheumatology & Therapeutics Review for Organizations & Societies Comparative Effectiveness Studies of Biologics Learning Objectives Understand the motivation for comparative effectiveness research
More informationTocilizumab F. Hoffmann-La Roche Ltd. Protocol MA 27950, Version 3.0 1
Protocol MA 27950, Version 3.0 1 Protocol MA 27950, Version 3.0 2 TABLE OF CONTENTS PROTOCOL ACCEPTANCE FORM... 8 PROTOCOL SYNOPSIS... 9 1. BACKGROUND... 15 1.1 Background on Rheumatoid Arthritis... 15
More informationSCIENTIFIC DISCUSSION. London, 27 April 2006 Product name: HUMIRA/TRUDEXA Procedure number: EMEA/H/C/ /II/26
SCIENTIFIC DISCUSSION London, 27 April 2006 Product name: HUMIRA/TRUDEXA Procedure number: EMEA/H/C/481-482/II/26 3.1. Introduction Adalimumab is a recombinant human immunoglobulin (IgG 1 ) monoclonal
More informationNew Evidence reports on presentations given at EULAR Tocilizumab for the Treatment of Rheumatoid Arthritis
New Evidence reports on presentations given at EULAR 2012 Tocilizumab for the Treatment of Rheumatoid Arthritis Report on EULAR 2012 presentations Tocilizumab monotherapy is superior to adalimumab monotherapy
More informationEfficacy, Safety and Tolerability of 150 mg Q2W Dose of the PCSK9 mab REGN727/SAR236553: Data from Three Phase 2 Studies
Efficacy, Safety and Tolerability of 150 mg Q2W Dose of the PCSK9 mab REGN727/SAR236553: Data from Three Phase 2 Studies Michael J. Koren, 1 Evan A. Stein, 2 Eli M. Roth, 3 James M. McKenney, 4 Dan Gipe,
More informationThe study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationClinicalTrials.gov Protocol Registration and Results System (PRS) Receipt Release Date: 10/11/2013. ClinicalTrials.gov ID: NCT
ClinicalTrials.gov Protocol Registration and Results System (PRS) Receipt Release Date: 10/11/2013 ClinicalTrials.gov ID: NCT00168454 Study Identification Unique Protocol ID: 191622-077 Brief Title: A
More information2.0 Synopsis. Adalimumab DE018 OLE (5 year) Clinical Study Report R&D/06/369. (For National Authority Use Only) to Part of Dossier: Volume:
2.0 Synopsis Abbott Laboratories Name of Study Drug: Name of Active Ingredient: Individual Study Table Referring to Part of Dossier: Volume: Page: (For National Authority Use Only) Title of Study: A Multi-center
More informationPRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION KEVZARA. sarilumab
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr KEVZARA sarilumab solution for subcutaneous injection 150 mg/1.14 ml or 200 mg/1.14 ml solution in a single-dose pre-filled syringe interleukin-6
More informationSynopsis (C0743T10) CNTO 1275 Module 5.3 C0743T10. Associated with Module 5.3 of the Dossier
Module 5.3 Protocol: EudraCT No.: 2005-003525-92 Title of the study: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of, a Fully Human Anti-IL-12 Monoclonal Antibody, Administered
More informationAdalimumab M Clinical Study Report Final R&D/13/224
Diagnosis and Main Criteria for Inclusion: A parent or guardian had voluntarily signed and dated an informed consent form, approved by an institutional review board/independent ethics committee, after
More informationHIGHLIGHTS OF PRESCRIBING INFORMATION
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use safely and effectively. See full prescribing information for. (sarilumab) injection, for subcutaneous
More informationThe New and Emerging Agents: Dermatology
Psoriasis Treatment 2013: What is New and on the Horizon? Neil J Korman, MD, PhD Professor of Dermatology University Hospitals Case Medical Center Clinical Director Murdough Family Center for Psoriasis
More informationGSK Medicine: Study Number: Title: Rationale: Phase: Study Period: Study Design: Centers: Indication: Treatment: Objective:
GSK Medicine: abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) Study Number: 201147 Title: A IIIb, randomized, open-label study of the safety, efficacy, and tolerability of switching to a fixed-dose
More informationSYNOPSIS. Issue Date: 17 Jan 2013
STELARA (ustekinumab) Clinical Study Report CNTO1275PSA3002 24-Week CSR SYNOPSIS Issue Date: 17 Jan 2013 Name of Sponsor/Company Name of Finished Product Name of Active Ingredient(s) Janssen Research &
More information- Clinical Background, Motivation and my Experience at F2F meeting
Predicting randomized clinical trial results with realworld evidence: A case study in the comparative safety of tofacitinib, adalimumab and etanercept in patients with rheumatoid arthritis - Clinical Background,
More information1 Research grants; 2 Consulting fees; 3 Employee; 4 Speakers bureau; 5 Stocks, stock options, or bond holdings.
Screening & Randomization 11/7/211 1 2 Disclosures: This study was funded by Roche Efficacy and Safety of Tocilizumab in Patients With Systemic Juvenile Idiopathic Arthritis: 2-Year Data From a Phase III
More informationCimzia (certolizumab pegol) Data Showed Broad and Rapid Relief From Burden of Symptoms In Rheumatoid Arthritis Patients
Cimzia (certolizumab pegol) Data Showed Broad and Rapid Relief From Burden of Symptoms In Rheumatoid Arthritis Patients Rapid, sustained and clinically meaningful improvement in wideranging patient-reported
More informationTHERAPEUTIC AREA AND FDA APPROVED INDICATIONS: See USPI.
PFIZER INC. These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert. For publications based on this study, see associated bibliography.
More informationANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT RoActemra 20 mg/ml concentrate for solution for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml concentrate contains
More informationPage: 17 December 2012 (Study M13-692) 22 October 2013 (Study M13-692)
2.0 Synopsis AbbVie Inc. Name of Study Drug: Adalimumab Name of Active Ingredient: D2E7 Individual Study Table Referring to Part of Dossier: Volume: Page: (For National Authority Use Only) Title of Studies:
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationACTEMRA SC formulation is not intended for intravenous administration.
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ACTEMRA safely and effectively. See full prescribing information for ACTEMRA. ACTEMRA (tocilizumab)
More informationABSTRACT Objective: To evaluate effects of the anti-interleukin-6 receptor monoclonal antibody sarilumab administered
To cite: Strand V, Reaney M, Chen C-I, et al. Sarilumab improves patient-reported outcomes in rheumatoid arthritis patients with inadequate response/ intolerance to tumour necrosis factor inhibitors. RMD
More informationPfizer Announces Modification To Ongoing Tofacitinib FDA Post- Marketing Requirement Study In Patients With Rheumatoid Arthritis
February 19, 2019 Media Contact: Neha Wadhwa M: +1 212-733-2835 E: Neha.Wadhwa@pfizer.com Investor Contact: Charles Triano O: +1 212-733-3901 E: Charles.E.Triano@pfizer.com Pfizer Announces Modification
More information1.0 Abstract. Title. Keywords. Adalimumab, Rheumatoid Arthritis, Effectiveness, Safety. Rationale and Background
1.0 Abstract Title Assessment of the safety of adalimumab in rheumatoid arthritis (RA) patients showing rapid progression of structural damage of the joints, who have no prior history of treatment with
More informationSponsor. Novartis Pharmaceuticals Corporation Generic Drug Name. Agomelatine Therapeutic Area of Trial. Major depressive disorder Approved Indication
Clinical Trial Results Database Page 1 Sponsor Novartis Pharmaceuticals Corporation Generic Drug Name Therapeutic Area of Trial Major depressive disorder Approved Indication Investigational drug Study
More informationClinical Trial Synopsis TL-OPI-518, NCT#
Clinical Trial Synopsis, NCT# 00225264 Title of Study: A Double-Blind, Randomized, Comparator-Controlled Study in Subjects With Type 2 Diabetes Mellitus Comparing the Effects of Pioglitazone HCl vs Glimepiride
More informationGSK Medicine: Study Number: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationGSK 165: anti-gm-csf antibody
GSK 165: anti-gm-csf antibody A novel mechanism with potentially differentiated impact on pain in the treatment of Rheumatoid Arthritis 23 October 2018 Cautionary statement regarding forward-looking statements
More informationACTEMRA can be used alone following discontinuation of glucocorticoids.
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use safely and effectively. See full prescribing information for. (tocilizumab) injection, for intravenous
More information24-Week CNTO1275PSA3001 Clinical Study Report
24-Week CNTO1275PSA3001 Clinical Study Report SYNOPSIS Issue Date: 17 Jan 2013 Name of Sponsor/Company Name of Finished Product Name of Active Ingredient(s) Janssen Research & Development, Inc Ustekinumab
More informationEfficacy and Safety of Rituximab in the Treatment of Rheumatoid Arthritis and ANCA-associated Vasculitis
New Evidence reports on presentations given at ACR/ARHP 2010 Efficacy and Safety of Rituximab in the Treatment of Rheumatoid Arthritis and ANCA-associated Vasculitis Report on ACR/ARHP 2010 presentations
More informationStudy No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:
The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.
More informationCriteria Inclusion criteria Exclusion criteria. despite treatment with csdmards, NSAIDs, and/or previous anti-tnf therapy and/or
Supplementary Material Table S1 Eligibility criteria (PICOS) for the SLR Criteria Inclusion criteria Exclusion criteria Population Adults (aged 18 years) with active PsA despite treatment with csdmards,
More informationOlumiant (baricitinib) NEW PRODUCT SLIDESHOW
Olumiant (baricitinib) NEW PRODUCT SLIDESHOW Introduction Brand name: Olumiant Generic name: Baricitinib Pharmacological class: Janus kinase (JAK) inhibitor Strength and Formulation: 2mg; tabs Manufacturer:
More informationCanadian Society of Internal Medicine Annual Meeting 2016 Montreal, QC
Canadian Society of Internal Medicine Annual Meeting 2016 Montreal, QC Update on the Treatment of Rheumatoid Arthritis Sabrina Fallavollita MDCM McGill University Canadian Society of Internal Medicine
More information