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1 be 12/SC/ A PHASE III PROSPECTIVE, TWO-COHORT NON-RANDOMIZED, MULTI- CENTRE, MULTINATIONAL, OPEN LABEL STUDY TO ASSESS THE SAFETY OF ASSISTED- AND SELF-ADMINISTERED SUBCUTANEOUS TRASTUZUMAB AS ADJUVANT THERAPY IN PATIENTS WITH OPERABLE HER2-POSITIVE EARLY BREAS 24/05/ /05/2016 Finished 13/SC/ Phase III Placebo controlled study using siponimod (BAF132) in secondary progressive multiple sclerosis (CCRN 1056) /04/ /04/2016 Y Finished 12/LO/ NCRN422 ALCANZA - brentuximab vedotin vs investigator's choice in CD30+ cutaneous T-cell lymphoma /05/ /05/2016 N Finished 12/LO/ CCRN 829 (SURTAVI) /05/ /05/2016 N Finished REC NCRN /02/ /02/2016 Y Finished 12/LO/ ECHELON-1 (Millenium C25003) /04/ /04/2016 Y Finished 13/NW/ A randomized, double-blind, placebo-controlled, phase 3 study of brentuximab vedotin and CHP (A+CHP) versus CHOP in the frontline treatment of patients with CD30-positive mature T-cell lymphomas /11/ /11/2016 N Finished 13/NW/ A multicenter, international, randomized, parallel group, double blind, placebo-controlled CArdiovascular Safety & Renal Microvascular outcome with LINAgliptin, 5 mg once daily in patients with type 2 diabetes mellitus at /07/ /07/2016 Y Finished high vascular risk. CARMELIN 13/NI/ OCS Sparing Study /05/ /05/2016 Y Finished 13/EE/ CCRN SIGNATURE /04/ /04/2016 Y Finished 13/EM/ RELAX 2 - Serelaxin when added to standard therapy in acute heart failure /08/ /08/2016 Y Finished 13/SC/ A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO- CONTROLLED STUDY TO ASSESS THE EFFICACY, SAFETY, AND TOLERABILITY OF LEBRIKIZUMAB IN ADOLESCENT PATIENTS WITH SEVERE UNCONTROLLED ASTHMA WHO ARE ON INHALED CORTICOSTEROIDS AND A SECOND CONTROLLER MEDICAT /06/ /06/2016 N Finished 14/NE/ A Phase 3, Randomized, Double-blind Active-controlled Study Evaluating Momelotinib vs. Ruxolitinib in Subjects with Primary Myelofibrosis (PMF) or Post-Polycythemia Vera or Post- Essential Thrombocythemia Myelofibrosis (Post-PV/ET MF) /02/ /02/2016 Y Finished 13/EM/ NCRN552 - oral LDK378 versus standard chemotherapy in ALK- rearranged (ALK-positive) NSCLC /04/ /04/2016 Y Finished 14/SC/ MCRN3165 (SD744) Cubist PSI Osteomyelitis /07/ /07/2016 N Finished 14/SC/ Extension Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Subjects with Moderate to Severe Endometriosis- Associated Pain 01/02/ /02/2016 Finished 13/LO/ Phase 3, Randomized, Open Label, Active-Controlled Study to Evaluate the Efficacy and Safety of FG4592 in the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis /07/ /07/2016 Y Finished 14/LO/ /LO/ Phase 3, Randomised, Placebo-Controlled Double-Blind Study of Oral Ixazomib Citrate (MLN9708) Maintenance Therapy in patients with Multiple Myeloma Following Autologous Stem Cell Transplant NCRN Bosutinib vs Imatinib in Chronic Phase Philadelphia Chromosome Positive CML /03/ /03/2016 N Finished /04/ /04/2016 Y Finished
2 be 14/NE/ A randomised, double-blind, placebo-controlled, parallel group, multicentre, phase III study to evaluate the efficacy and safety of 2 doses of benralizumab (MEDI-563) in patients with severe to very severe Chronic Obstructive Pulmonary Disease (COPD) /11/ /11/2016 Y Finished 14/WM/ A Phase 3, Randomized Study To Evaluate the Efficacy of Momelotinib Versus Best Available Therapy in Anemic or Thrombocytopenic Subjects with Primary Myelofibrosis, Post- polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis /01/ /01/2016 N Finished 14/EM/ PERSIST 2 - A Randomised Controlled Phase III Study Of Oral Pacritinib Versus Best Available Therapy In Patients With Thrombocytopenia And Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Or Post-Essential Thrombocythemia Myelofibrosis /04/ /04/2016 Y Finished 14/LO/ DUAL antithrombotic therapy with dabigatran etexilate (RE-DUAL PCI) /10/ /10/2016 N Finished 14/EM/ RENA3444 (BRIGHT-SC) /04/ /04/2016 Y Finished 14/NE/ A Phase II, Randomised, Double Blind, Placebo-controlled Bronscoscopy study to evaluate the effects of Lebrikizumab on airway eosinophilic inflammation in patients with uncontrolled asthma on inhaled corticosteroids and a second controller medication /08/ /08/2016 Y Finished 14/LO/ A PHASE II, OPEN-LABEL STUDY EVALUATING THE SAFETY AND EFFICACY OF GDC-0199 (ABT-199) PLUS BENDAMUSTINE PLUS RITUXIMAB (BR) IN COMPARISON WITH BR ALONE OR GDC-0199 PLUS RITUXIMAB (R) IN PATIENTS WITH RELAPSED AND REFRACTORY FOLLICULAR NON HODGKIN'S L /03/ /03/2016 Y Finished 14/LO/ CARD STRENGTH /08/ /08/2016 N Finished 14/WS/ CANC /04/ /04/2016 Finished 14/LO/ A Phase III open-label multicenter randomised study to investigate the efficacy and safety of MPDL3280A (Anti-PD-L1 antibody) compared to chemotherapy in patients with locally advanced or metastatic bladder cancer after the failure with platinum-cont /05/ /05/2016 Y Finished 14/LO/ NCRN Unresected Stage IIIB - IVM1a Melanoma Treated with Talimogene Laherparepvec /06/ /06/2016 N Finished 14/NE/ ABBVIE - M /07/ /07/2016 Y Finished 15/LO/ CHIL3887 mepolizumab in children from 6 to 11 years of age with severe eosinophilic asthma /06/ /06/2016 N Finished 14/WS/ Multicenter, randomised, double-blind, double-dummy, active- comparator event-driven, superiority phase III study of secondary prevention of stroke and prevention of systemic embolism in patients with a recent Embolic Stroke of Undetermined Source (ES /12/ /12/2016 N Finished 14/LO/ A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate the Efficacy and Safety of Roxadustat in the Maintenance Treatment of Anemia in End Stage Renal Disease Subjects on Stable Dialysis /01/ /01/2016 Y Finished 14/SS/ A Phase 3b, Multicenter, Randomized-withdrawal, Placebo- controlled, Double- blind, Parallel-group Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day, Splitdose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to Earl /03/ /03/2016 Y Finished
3 be 15/LO/ /NW/ PLAIT - A Pivotal Multicenter Trial of Moxetumomab Pasudotox in Relapsed/Refractory Hairy Cell Leukemia /05/ /05/2016 N Finished Treatment of Chronic Idiopathic Cough (CIC) and Chronic Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF) with PA /05/ /05/2016 Y Finished 15/SC/ CheckMate A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy with Nivolumab versus Ipilimumab after Complete Resection of Stage IIIb/c or Stage IV Melanoma in Subjects who are at High Risk for Recurrence (CheckMate 238: CHECKpo /03/ /03/2016 Y Finished 15/LO/ Checkmate 171: An Open-Label, Multicenter Clinical Trial with Nivolumab (BMS ) Monotherapy in Subjects with Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC) who Have Received at Least One Prior Systemic Regimen for t /07/ /07/2016 Y Finished 15/WM/ A Phase 3, Randomised, Controlled, Open-label Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination with VMP (D-VMP), in Subjects with Previously Untreated Multiple Myeloma who are Ineligible for High- dose Th /07/ /07/2016 N Finished 15/EE/ A Phase III, randomised, double blind, placebo-controlled, parallel group, efficacy, safety and tolerability trial of Empagliflozin as Adjunctive to insulin over 52 weeks in patients with Type 1 DiabeteS MEllitus (EASE-2) /09/ /09/2016 Y Finished 15/NW/ A phase 3. randomized, double-blind,placebo-group, multicenter study to evaluate the efficacy, safety, and tolerability of LX4211 as adjunct therapy in adult patients with type 1 diabetes mellitus who have inadequate glycemic control with insulin the /04/ /04/2016 N Finished 15/WM/ An open-label Phase 1b study of ACP-196 in subjects with multiple myeloma /03/ /03/2016 N Finished 12/LO/ BEECH /04/ /04/2016 N Finished 15/SC/ An Open-Label, Randomized Phase 3 Trial of Nivolumab and Nivolumab plus Ipilimumab versus Platinum Doublet Chemotherapy in Patients with Chemotherapy-Na?ve Stage IV or Recurrent Non-Small Cell Lung Cancer 19/12/ /12/2016 Finished (NSCLC) 12/SC/ SafeHer: Safety study with subcutaneous Trastuzumab in breast cancer /09/ /05/2016 N Finished 12/EM/ Safety and tolerability of ONO-4059 in patients with NHL & CLL /06/ /06/2016 N Finished 14/SW/ ACP-196 in subjects with Relapsed or Refractory de Novo ABC DLBCL /01/ /01/2016 N Finished 14/LO/ VS Phase 1 study in relapsed malignant mesothelioma /04/ /03/2016 N Finished 15/ES/ Open Label, Multinational, Multicenter, Real World Treatment Study of Single Agent AZD9291 for Patients with Advanced/Metastatic Epidermal Growth Factor Receptor (EGFR) T790M Mutation Positive Non Small Cell Lung Cancer (NSCLC) Who Have Received Prio 01/09/ /09/2016 Finished 15/LO/ An Open-label, Randomized, Phase 3 Study of Nivolumab or Chemotherapy in Subjects with Relapsed Small-cell Lung Cancer after Platinum based First Line Chemotherapy (Checkmate 331) 26/09/ /09/2016 Finished
4 be 15/WS/ /NW/ /EE/ A Phase 1b Dose Escalation and Dose Expansion Study of ONO/GS in Combination with other Targeted Anti-cancer Therapies in Subjects with B- cell Malignancies GLYCEMIC CONTROL AND TREATMENT SATISFACTION USING FINESSE VERSUS PEN FOR INITIATING BOLUS INSULIN DOSING IN TYPE 2 DIABETES MELLITUS PATIENTS NOT ACHIEVING GLYCEMIC TARGETS ON BASAL INSULIN WITH/WITHOUT ANTI- HYPERGLYCEMIC AGENTS Multi-arm, non-randomised, open-label phase 1B study to evaluate GSK in combination with paclitaxel and carboplatin, or docetaxel or as single agent in subjects with solid malignancies and deregulated FGF pathway signalling /11/ /11/2016 Y Finished /08/ /08/2016 N Finished 02/08/ /08/2016 Finished 14/EM/ LCZ696 in patients from Paradigm HF study /07/ /07/2016 Y Finished 15/LO/ RESP /12/ /12/2016 Y Finished 15/LO/ Drug-drug interaction study with nintedanib and pirfenidone /12/ /12/2016 N Finished 16/LO/ DIAB 5013 A real-world, point of care, randomized, 2-arm, open, 52-week study to evaluate the effect of a digital disease management support tool in patients with type 2 diabetes mellitus /10/ /10/2016 N Finished 15/LO/ A Multiarm-arm Phase 3 Randomized Placebo Controlled Double Blind Clinical Trial to Investigate the Efficacy and Safety of BMS in Heavily Treatment Experienced Subjects Infected with Multi-drug Resistant HIV /12/ /12/2016 N Finished 15/NW/ A Phase 3, Randomized, Double-blind, Placebocontrolled, Parallel- group, Multicenter Study to Evaluate the Net Clinical Benefit of Sotagliflozin as Adjunct to Insulin Therapy in Type 1 Diabetes /08/ /08/2016 N Finished 15/NW/ FUTURE 5: A phase III, randomised, double-blind, placebo controlled multicentre study of subcutaenous secukinumab (150 mg and 300 mg) in prefilled syringe to demonstrate efficiency (including inhibition of structural damage), safety and tolerability /09/ /09/2016 N Finished 15/SC/ Clinical Study Protocol M A Phase 3, Randomized, Double- Blind Study Comparing ABT-494 to Placebo in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti- Rheum /12/ /12/2016 N Finished 15/WM/ An Open-label Study to Assess the Long-term Safety and Efficacy of ONO/GS in Subjects with Relapsed/Refractory B-cell malignancies 01/04/ /04/2016 Finished 15/SC/ NJ002 25/05/ /05/2016 Finished 15/LO/ : Efficacy And Long-Term Safety Of Oral Semaglutide Versus Sitagliptin In Subjects With Type 2 Diabetes Mellitus. A 78-Week, Randomised, Double- Blind, Double-Dummy, Active-Controlled, Parallel-Group, Multi-Centre, Multi- National, Four-Armed Tria /07/ /07/2016 Y Finished 15/EE/ A Phase III, randomised, double blind, placebo-controlled,parallel group, efficacy, safety and tolerability trial of once daily, oral doses of Empagliflozin as Adjunctive to insulin therapy over 26 weeks in patients with Type 1 Diabetes Mellitus (EAS /12/ /12/2016 N Finished 15/EM/ Effect of Tralokinumab on Airway Inflammation in Asthma /11/ /11/2016 Y Finished
5 be 16/EM/ A 24 week, Multicentre, Randomized, Open Label, 2 ARm Parallel- group study evaluating the Efficacy and Safety of Patient - versus Physicianmanaged Titration of Insulin Glargine U300 in Type 2 Diabetes Mellitus /12/ /12/2016 N Finished 16/NE/ AF : A 12-Week Study to Assess the Efficacy and Safety of AF-219 in Subjects with Treatment Refractory Chronic Cough /07/ /07/2016 Y Finished 13/LO/ CCRN A Phase 2, Randomized, Double-Blind, Placebo- Controlled, Event-Driven, Multi-Center study to Assess the Efficacy and Safety of GS-6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER) CCRN /05/ /12/2016 N Finished 14/EM/ A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo- Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura /05/ /05/2016 Y Finished 13/NW/ SEVERE SEPSIS / COAGULOPATHY TRIAL ART /05/ /05/2016 N Finished
Target date to recruit patients agreed? Target range minimum. Target range maximum. Agreed 1 1 Agreed 01/01/ /01/2016 Recruitment Finished
No REC Reference IRAS No Title Target number of patients agreed? Target range minimum Target range maximum Target date to recruit patients agreed? Planned Recruitment end date No of patients recruited
More informationTarget date to recruit patients agreed? Target range. maximum. minimum. Date. 5 Agreed 26/01/ /11/2015 Recruitment Finished.
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