Target date to recruit patients agreed? Target range minimum. Target range maximum. Agreed 1 1 Agreed 01/01/ /01/2016 Recruitment Finished

Transcription

1 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 at agreed target date study actually closed to recruitment at STH Reason for closure to recruitment at STH A Compassionate Use Open-Label Study of Anti IL-5 (Mepolizumab) Treatment in Subjects with 1 10/H1307/ Hypereosinophilic Syndrome An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme Sponsored Studies of 2 09/H1211/ Aletmuzumab Agreed 1 1 Agreed 01/01/ /01/2016 Recruitment Finished Agreed Agreed 01/08/ /08/2015 Recruitment Finished 3 11/LO/ LUXHead & Neck 2; A randomised, doubleblind, placebo controlled, phase III study to evaluate the efficacy and safety of afatinib (BIBW 2992) as adjuvant therapy after chemoradiotherapy in primary unresected patients with stage III, IVa, or IVb locoregionally advanced head and neck squamous cell carcinoma. Agreed 5 5 Agreed 26/01/ /11/2015 Recruitment Finished A randomised, double-blind, placebo controlled, multicentre trial to measure the oral corticosteroidsparing effect of lebrikizumab in patients with severe corticosteroid 4 13/NI/ dependent asthma - VOCALS 5 12/NW/ Efficacy, safety, and tolerability of oral GRT6005 versus morphine sulfate PR in subjects with chronic moderate to severe pain related to cancer. Agreed 7 7 Agreed 02/02/ /02/2016 Recruitment Finished Agreed 4 4 Agreed 29/01/ /08/2015 Recruitment Finished

2 6 12/LO/ A randomised, multicentre, openlabel Phase III study to evaluate the efficacy and safety of Trastuzumab Emtansine versus Trastuzumab as adjuvant therapy for patients with HER2-positive primary breast cancer who have residual tumour present pathologically in the breast or axillary lymph nodes following preoperative therapy. KATHERINE Agreed 3 3 Agreed 30/04/ /01/2016 Recruitment Finished 7 13/LO/ /LO/ GS6624 in Subjects with Idiopathic Pulmonary Fibrosis (RAINIER) International non-randomized, single arm, long-term follow-up study of patients with uncontrolled hypertension Agreed 5 5 Agreed 30/06/ /08/2015 Recruitment Finished Agreed Agreed 31/01/ /08/2015 Recruitment Finished 9 12/WS/ A randomised, double blind, placebo controlled, parallel group study to evaluate the effect of SAR236553/REGN727 on the occurrence of cardiovascular events in patients who have recently experienced an acute coronary syndrome Agreed Agreed 01/12/ /12/2015 Recruitment Finished 10 14/LO/ A Phase 3, Randomized, Open Label Study Investigating the Efficacy of the BiTE? Antibody Blinatumomab Versus Standard of Care Chemotherapy in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) (TOWER Study) Agreed 1 5 Agreed 01/03/ /09/2015 Recruitment Finished

3 A randomized, double-blind, parallel-group, placebo and active controlled, multicenter study to evaluate the efficacy, safety and tolerability of combinations of solifenacin succinate 5mg and mirabegron 25 and 50mg compared to slifenacin succinate and mirabegron monotherapy in 11 13/LO/ the treatment of overactive bladder. Agreed 8 8 Agreed 13/03/ /02/2016 Recruitment Finished 12 13/SC/ /WM/ A Phase III randomized, 3-arm, open label, multicenter study of LGX818 plus MEK162 and LGX818 monotherapy compared with vemurafenib in patients with unresectable or metastatic BRAF V600 mutant melanoma Agreed 3 3 Agreed 31/03/ /10/2015 Recruitment Finished A multinational, randomised, double blind, placebo controlled trial to evaluate the effect of ticagrelor 90mg twice daily on the incidence of cardiovascular death, myocardial infarction or stroke in patients with type 2 diabetes mellitus. (THEMIS) Agreed Agreed 03/06/ /05/2016 Withdrawn By Sponsor 14 14/WS/ A phase 3, multicentre, open label, randomised trial of nab-paclitaxel plus Gemcitabine versus Gemcitabine alone as adjuvant therapy in subjects with surgically resected pancreatic adenocarcinoma Agreed Agreed 30/06/ /03/2016 Recruitment Finished

4 15 14/LO/0362 Prospective, randomized, placebocontrolled, double-blind, multicenter, parallel-group, 24- week study to assess the efficacy, safety and tolerability of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) Agreed 2 2 Agreed 18/03/ /03/2016 Recruitment Finished 16 14/NW/ /LO/ /LO/ Comparative testing of Transfix Vacuum blood collection tubes and Cytochex blood collection tubes for FDA 510 (k) submission A Prospective, Interventional Pharmacokinetic and Safety Study of DTG/ABC/3TC in Pregnant Women A Multicenter Phase 3 Randomized, Open-Label Study of Bosutinib versus Imatinib in Adult Patients with Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia BFORE Agreed Agreed 25/02/ /02/2016 Recruitment Finished Agreed 0 0 Agreed 30/09/ /09/2015 Recruitment Finished Agreed 3 3 Agreed 31/08/ /08/2015 Recruitment Finished Study : Albiglutide versus Placebo in Subjects with new /LO/ onset type 1 diabetes mellitus 20 14/LO/ GS-US : A Randomized, Open Label, Phase 4 Study Evaluating the Renal Effect of Elvitegravir/Cobicistat/Emtricitabine /Tenofovir DF or other Tenofovir DF-containing Regimens (Ritonavirboosted Atazanavir plus Agreed 3 3 Agreed 26/05/ /05/2016 Recruitment Finished Agreed 1 3 Agreed 29/12/ /07/2015 Recruitment Finished

5 A Phase 2, Randomized, Placebo Controlled, Double Blind, Proof of concept Study of the Efficacy and Safety of PF in Subjects 21 14/YH/ with Huntington s disease Agreed 4 10 Agreed 19/02/ /03/2016 Recruitment Finished 22 14/SS/ A Phase 3b, Multi-center, Randomized-withdrawal, Placebocontrolled, Double-blind, Parallelgroup Trial to Compare the Efficacy and Safety of Tolvaptan (45 to 120 mg/day, split dose) in Subjects with Chronic Kidney Disease Between Late Stage 2 to Early Stage 4 Due Not to Autosomal Dominant Polycystic Available / Kidney Disease Agreed 5 5 Not Agreed 3 28/01/2016 Recruitment Finished 23 15/YH/ Acceptability study on Nutricomp Drink Plus in adult patients Agreed Agreed 31/10/ /10/2015 Recruitment Finished 24 14/SC/ /EM/ A phase 3 randomized, doubleblind study assessing the efficacy and safety of pf and adalimumab in combination with methotrexate in subjects with moderately to severely active rheumatoid arthritis who have had an inadequate response to methotrexate A Phase II Randomised, Double Blind, Placebo Controlled, Multicentre Study of VS-6063 in Subjects With Malignant Pleural Mesothelioma Agreed 1 4 Agreed 28/02/ /02/2016 Recruitment Finished Agreed 1 1 Agreed 30/09/ /09/2015 Withdrawn By Sponsor

6 A Phase 3, Randomized, Placebo- Controlled, Double-Blind Study of Oral MLN9708 Maintenance Therapy in Patients with Multiple Myeloma Following Autologous 26 14/LO/ Stem Cell Transplant - Millennium Agreed 3 3 Agreed 01/12/ /03/2016 Recruitment Finished 27 14/SC/ /EM/ A Multicenter, Randomized, Double Blind, Placebo controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Dapagliflozin as an Add on to Insulin Therapy in Subjects with Type 1 Diabetes Mellitus An open-label, multicenter study to provide patients with chronic heart failure and reduced ejection fraction access to LCZ696 following participation in PARADIGM-HF Agreed 5 5 Agreed 31/10/ /04/2016 Recruitment Finished Agreed 2 2 Agreed 29/02/ /02/2016 Recruitment Finished 29 14/EE/ /SS/ TOPAZ: A long-term follow-up study for Multiple Sclerosis patients who have completed the alemtuzumab Extension Study (CAMMS03409 STH15866) Agreed 0 16 Agreed 01/07/ /08/2015 Recruitment Finished A Phase 2, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Study of GS in Subjects with Pulmonary Arterial Hypertension Agreed 2 2 Agreed 03/02/ /10/2015 Recruitment Finished 31 14/NW/ A 4 week phase 2a, multicentre, randomised, doubleblind, placebocontrolled add-on study into safety, tolerability andefficacy of 200 mg t.i.d. of PL37 in patients with peripheral neuropathic pain of diabetic origin treated with pregabalin or gabapentin Agreed 7 7 Agreed 15/03/ /03/2016 Recruitment Finished

7 32 15/LO/ /YH/ /LO/ A Phase 3 Multicenter, Double- Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Doravirine (MK-1439) 100 mg Once Daily Versus Darunavir 800 mg Once Daily plus Ritonavir 100 mg Once Daily, Each in Combination with TRUVADA or EPZICOM/KIVEXA, in Treatment- Naïve HIV-1 Infected Subjects A phase 3, randomized, doubleblind, placebo-controlled study investigating the efficacy and safety of multiple Dupilumab dose regimens administered as monotherapy for maintaining treatment response in patients with atopic dermatitis. 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 the Treatment of Stage IIIb/IV SqNSCLC Agreed 1 4 Agreed 30/09/ /09/2015 Recruitment Finished Agreed 0 5 Agreed 01/12/ /12/2015 Recruitment Finished Agreed 9 9 Agreed 15/06/ /06/2016 Recruitment Finished 35 15/NW/ A Phase 3, Randomized, Doubleblind, Placebo-controlled, Parallel- Group, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of LX4211 as Adjunct Therapy in Adults Patients with Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control with Insulin Therapy. Agreed 5 8 Agreed 30/04/ /04/2016 Recruitment Finished

8 36 15/LO/ /SC/ An open-label, multi-center, nonrandomized Phase Ib study to investigate safety and tolerability of radium Ra 223 dichloride (BAY ) administered in combination with paclitaxel in cancer subjects with bone lesions. Agreed 2 4 Agreed 28/02/ /02/2016 Recruitment Finished A randomised, double-blind, placebo-controlled, phase 3 trial of doxorubicin plus olaratumab versus doxorubicin plus placebo in patients with advanced or metastatic soft tissue sarcoma. Agreed Agreed 30/06/ /05/2016 Withdrawn By Sponsor