PERFORMANCE IN DELIVERING CLINICAL RESEARCH Q4 (2014-2015)

Research Ethics Committee Reference Number / Name of Trial / Target Recruitment / Date Agreed to Recruit Target Number / Trial Status / Target Met Within Agreed Time
14/EM/1059 / 047 FIT - C-935788-047 A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura / 3 / 15/06/2015 / OPEN / N/A
14/NW/0130 / RESPONSE: A randomised, double blind, multi-center, placebo-controlled study to evaluate the efficacy, safety, and tolerability of NT100 in pregnant women with a history of unexplained recurrent pregnancy loss (RPL) / 7 / 31/03/2015 / CLOSED AT SITE / NO
13/NW/0858 / Assessment of an Education and Guidance programme for Eliquis Adherence in Non-Valvular Atrial Fibrillation (AEGEAN) / 12 / 31/03/2015 / CLOSED - In Follow-up / NO
14/EE/0102 / ENSURE in AF (atrial fibrillation) study. A prospective, randomized, openlabel, blinded endpoint evaluation (PROBE) parallel group study comparing edoxaban (DU176b) with enoxaparin/warfarin followed by warfarin alone in subjects undergoing planned electrical cardioversion of nonvalvular atrial fibrillation / 9 / 01/05/2015 / OPEN / N/A
14/WS/0004 / Open-Label Extension Study of EFC12492, R727-CL-1112, EFC12732, & LTS11717
Studies to Assess the Long-Term Safety and Efficacy of Alirocumab in Patients
with Heterozygous Familial Hypercholesterolemia ODYSSEY OLE / 4 / 31/12/2014 / CLOSED / NO
14/EE/0059 / Post-Market Multicentric Evaluation of the AQUESYS XEN Implant in Moderate Primary Open Angle Glaucoma Subjects. MS-001 Study / 10 / 02/02/2015 / CLOSED - In Follow-up / NO
14/EE/0102 / SPIRE 2: B1481038 Phase 3 multi-center, double-blind, randomized, Placebo-controlled, parallel group evaluation of the Efficacy, safety, and tolerability of pf-04950615, in reducing the Occurrence of major cardiovascular events in high risk Subjects / 2 / 01/10/2015 / OPEN / N/A
14/SC/0032 / Phase 3, Multi-Centre, Double-Blind, Randomised, Placebo-controlled, Parallel Group Evaluation of the Efficacy, Safety and Tolerability of PF-04950615, in reducing the occurrence of major cardiovascular events in high risk subjects. SPIRE 1. / 5 / 31/10/2014 / OPEN / N/A
14/SC/0100 / Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion / 6 / 31/03/2015 / CLOSED - In Follow-up / YES
13/LO/1320 / A Phase III, Multi-National, Multi-Center, Randomized, Masked, Controlled, Safety and Efficacy Study of a Fluocinolone Acetonide Intravitreal (FAI) Insert in Subjects with Chronic Non-Infectious Uveitis Affecting the Posterior Segment of the Eye (pSivida) / 2 / 31/03/2015 / CLOSED - In Follow-up / YES
13/NE/0269 / PR-30-5011-C - A Phase 3 Randomized Double-Blind Trial of Maintenance with Niraparib Versus Placebo in Patients with Platinum Sensitive Ovarian Cancer / 2 / 30/09/2015 / OPEN / YES
13/EE/0241 / SIGNATURE. Secukinumab In patients with moderate to severe active, chronic plaque psoriasis who have failed on TNFα antaGoNists: A clinical Trial EvalUating Treatment REsults / 2 / 01/02/2015 / CLOSED - In Follow-up / YES
14/WM/003 / HYDRUS V: A Prospective, Multicentre, Randomised, Comparison of the Hydrus™ to the iStent™ for Lowering Intraocular Pressure in Primary Open Angle Glaucoma / 10 / 28/04/2015 / OPEN / N/A
13/SC/0423 / Spock - A dose finding study to assess the safety and efficacy of K-877 in patients with statin-controlled LDL-C but abnormal lipid levels / 2 / 15/05/2014 / CLOSED - In Follow-up / YES
09/H0301/5 / THE CONTINUUM TRIAL. A Phase 3, Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel-group study of the Efficacy and Safety of Lenalidomide (Revlimid®) as Maintenance Therapy for Patients with B-Cell Chronic Lymphocytic Leukaemia following Second-line Therapy / 5 / 31/08/2015 / OPEN / N/A
13/LO/1264 / SOLO2. A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed BRCA Mutated Ovarian Cancer Patients who are in Complete or Partial Response Following Platinum based Chemotherapy / 6 / 08/01/2015 / CLOSED - In Follow-up / NO
13/EM/0254 / PROMETHEUS . A 12-month, randomized, double-masked, sham-controlled, multicenter study to evaluate the efficacy and safety of 0.5mg ranibizumab intravitreal injections in patients with visual impairment due to vascular endothelial growth factor (VEGF) driven macular edema (ME) / 2 / 06/08/2014 / CLOSED - In Follow-up / YES
13/WM/0208 / A Randomised, Double-blind, Placebo-controlled, Multiple Dose, Parallel, Multiple Dose-Level Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effect of AMG 557 in Systemic Lupus Erythematosus (SLE) Subjects with Active Lupus Arthritis / 3 / 30/05/2015 / OPEN / N/A
13/NE/0201 / SOLO 1. A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Patients with BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian Cancer following First Line Patinum Based Chemotherapy. / 4 / 08/01/2015 / CLOSED / NO
11/LO/1658 / LUMIGAN 056. A Multicenter, Double-masked, Randomized, Active-controlled, Parallel Study of the Safety and Efficacy of Once-daily Bimatoprost Preservative-free Ophthalmic Solution Compared to Twice-daily Timolol Ophthalmic Solution in Paediatric Patients With Glaucoma / 2 / 01/09/2014 / CLOSED / NO
12/LO/0984 / A Randomised, Open-Label, Phase 2 Study of the IDO Inhibitor INCB024360 (I) Versus Tamoxifen (C) for Subjects with Biochemical-recurrent-only Epithelial ovarian cancer, Primary Peritoneal Carcinoma or Fallopian Tube Cancer (P) Following Complete Remission with First-line Chemotherapy. / 4 / 01/08/2014 / CLOSED - In Follow-up / 0
13/NW/0363 / OSLER 2: A Multicenter Open-label Extension (OLE) Study to Assess the Long-term Safety and Efficacy of AMG 145 / 2 / 12/05/2014 / CLOSED - In Follow-up / NO
13/LO/0528 / PIONEER-AF. An Open-label, Randomized, Controlled, Multicenter Study ExplorIng Two Treatment Strategies of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention / 8 / 01/03/2015 / OPEN / YES
12/WS/0300 / ODYSSEY OUTCOMES: A Randomized, 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 / 20 / 31/122015 / OPEN / N/A
13/WM/0046 / HYDRUS III. A Prospective, Multicentre, Randomised Comparison of the Hydrustm Aqueous Implant to the iStent for lowering Intraocular Pressure in Glaucoma Subjects Undergoing Cataract Surgery / 18 / 28/04/2015 / OPEN / N/A
12/WS/0184 / Multi-Center, Open-Label, Randomized Study of Anti-CCR4 Monoclonal Antibody KW-0761 versus Investigator’s Choice in Subjects with Previously Treated Adult T-cell Leukemia-Lymphoma (ATL) / 3 / 01/05/2015 / OPEN / YES
13/LO/0049 / REPARO. An 8-week phase I/II, multicenter, randomized, double-masked, vehicle controlled parallel group study with a 48 or 56 week follow-up period to evaluate the safety and efficacy of two doses (10 µg/ml and 20 µg/ml) of recombinant human nerve growth factor eye drops solution versus vehicle in patients with Stage 2 and 3 of Neurotrophic Keratitis / 2 / 01/06/2015 / CLOSED - In Follow-up / NO
11/EM/0074 / LUMIGAN 054. A 2-year, multicenter, double-masked, randomized, parallel study of the safety of LUMIGAN® 0.1 mg/mL compared with LUMIGAN® 0.3 mg/mL in patients with glaucoma or ocular hypertension / 12 / 31/10/2014 / CLOSED - In Follow-up / NO
13/EM/0017 / A 3-Month, Multi-Center, Double-Masked Safety and Efficacy Study of Travoprost Ophthalmic Solution, 0.004% Compared to Timolol (0.5% or 0.25%) in Pediatric Glaucoma Patients / 2 / 01/08/2013 / CLOSED - In Follow-up / YES
12/EE/0533 / ODYSSEY Options II. A Randomized, Double-Blind Study of the Efficacy and Safety of REGN727 Added-on to Rosuvastatin versus Ezetimibe Added-on to Rosuvastatin versus Rosuvastatin Dose Increase in Patients Who are Not Controlled on Rosuvastatin (Regeneron R727-CL-1118) / 3 / 01/08/2013 / CLOSED - In Follow-up / NO
12/EE/0532 / ODYSSEY OPTIONS I. A Randomised, Double-Blind Study of the Efficacy and Safety of REGN727 Added-on to Atovastatin versus Ezetimibe Added-on to Atorvastatin versus Atorvastatin Dose Increase versus Switch to Rosuvastatin in Patients Who are Not Controlled on Atorvastatin (Regeneron R727-CL-1110) / 3 / 09/08/2013 / CLOSED / NO
12/NW/0670 / A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Crohn’s Disease (Protocol 20110232) TRAFFIC CD / 5 / 30/11/2014 / CLOSED - In Follow-up / NO
12/WM/0341 / FOURIER. A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When AMG 145 is Used in Combination With Statin Therapy In Patients with Clinically Evident Cardiovascular Disease / 20 / 31/03/2015 / CLOSED - In Follow-up / YES
12/LO/1650 / EYEGUARD-B: A randomized, double-masked, placebo-controlled study of the efficacy of gevokizumab in the treatment of patients with Behçet’s Disease uveitis. / 2 / 01/09/2014 / OPEN / N/A
12/WM/0348 / The RELIEF Study. Polycythemia Vera Symptom Study Evaluating Ruxolitinib Versus Hydroxyurea in a Randomized, Multicenter, Double-Blind, Double-Dummy, Phase 3 Efficacy and Safety Study of Patient Reported Outcomes / 1 / 15.11.2013 / CLOSED - In Follow-up / YES
12/WM/0290 / A double, randomised, multicentre study to evaluate safety and efficacy of AMG 145, compared with ezetimibe, in hypercholesterolemic subjects unable to tolerate an effective dose of a HMG-CoA reductase inhibitor 20110116 (GAUSS 2) / 6 / 23/07/2013 / CLOSED - In Follow-up / NO
12/LO/0482 / PERUSE. A multicenter, open-label, single-arm study of pertuzumab in combination with trastuzumab and a taxane in first line treatment of patients with HER2-positive advanced (metastatic or locally recurrent) breast cancer. / 4 / 30/11/2013 / CLOSED - In Follow-up / NO
12/NW/0014 / FOCUS FH. A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of Two Different Regimens of Mipomersen in Patients with Familial Hypercholesterolemia and Inadequately Controlled Low-Density-Lipoprotein Cholesterol (MIP038) / 6 / 22/11/2013 / CLOSED - In Follow-up / NO
10/H0718/93 / ALLOS PDX-017. A Multi-center, Randomized, Phase 3 Study of Sequential Pralatrexate Versus Observation in Patients with Previously Undiagnosed Peripheral T-cell Lymphoma Who Have Achieved an Objective Response Following Initial Treatment with CHOP-based Chemotherapy / 7 / 30/08/2013 / CLOSED - In Follow-up / NO
11/LO/1619 / ALTERNATIVE. Comparing safety & efficacy of AI/lapatanib/trastuzumab in HR+HER2 MBC / 5 / 02/01/2015 / CLOSED / NO

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