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NCT ID: NCT01226745 Terminated - Multiple Sclerosis Clinical Trials

A Safety and Efficacy Extension Study of ONO-4641 (MSC2430913A) in Patients With Relapsing-Remitting Multiple Sclerosis

DreaMS
Start date: October 2010
Phase: Phase 2
Study type: Interventional

The objective of this active-drug Extension Study is to evaluate the continuing safety and efficacy of ONO-4641 (MSC2430913A) in patients with relapsing-remitting multiple sclerosis (RRMS) in patients who have completed an initial 26-week study (ONO-4641POU006).

NCT ID: NCT01215942 Terminated - Clinical trials for Rheumatoid Arthritis

An Open Label Study for Participants With Rheumatoid Arthritis

Start date: June 2011
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to help answer if LY2127399 is safe and effective during long-term treatment in participants with Rheumatoid Arthritis. This study is comprised of 2 periods: Period 1: Unblinded treatment for up to 240 weeks for participants who enroll from Study H9B-MC-BCDO (BCDO) (NCT01202760) or Study H9B-MC-BCDV (BCDV) (NCT01202773) or up to 168 weeks for participants who enroll from Study H9B-MC-BCDM (BCDM) (NCT01198002). Period 2: 48-week post-treatment follow-up

NCT ID: NCT01200589 Terminated - Clinical trials for Non-Hodgkin's Lymphoma

Single Agent Ofatumumab Vs. Single Agent Rituximab in Indolent B-Cell Non Hodgkin Lymphoma Relapsed After Rituximab-Containing Therapy

HOMER
Start date: October 11, 2010
Phase: Phase 3
Study type: Interventional

This was a multi-center, parallel, active comparator controlled, open-label, randomized (1:1) phase III study of single agent ofatumumab compared to single agent rituximab in subjects with rituximab-sensitive indolent B-cell non hodgkin lymphoma that has relapsed at least 6 months after completing treatment with single agent rituximab or a rituximab-containing regimen. Subjects must have attained a Complete Response or Partial Response to their last prior rituximab containing therapy lasting at least six months beyond the end of rituximab therapy. Subjects were to receive four weekly doses of single agent ofatumumab (1000 mg) or rituximab (375 mg/m2), followed by ofatumumab (1000 mg) or rituximab (375 mg/m2) every 2 months for four additional doses. Therefore, subjects were to receive a total of eight doses of anti-CD20 antibody over 9 months. Subjects were evaluated for response after completion of the first four doses of therapy, after six doses of therapy, and after completion of study therapy. Subjects were to be followed until the end of the designated follow-up period (total study duration of 200 weeks) or until they meet the withdrawal criteria. The primary objective of the study OMB157D 2303 was to demonstrate the efficacy of Arzerra based on the primary endpoint (Progression-free survival (PFS) as assessed by the IRC) in patients with Indolent B-cell Non-Hodgkin's Lymphoma Relapsed After Rituximab-Containing Regimen. The Independent Data Monitoring Committee (IDMC) met on November 22, 2015 and recommended the termination of the study due to futility (cut-off date = 12Jun2015). The IDMC reviewed analyses results for progression free survival (PFS), overall response rate (ORR), and overall survival (OS). Novartis accepted this recommendation and the study was closed. Final analysis was performed (cut-off date =19 Dec 2016). As the study was stopped for futility, the primary objective was not met and some secondary endpoints, supportive of primary objective (Duration of Response (DOR), time to next therapy, and pharmacokinetics) were removed as secondary end points.

NCT ID: NCT01198002 Terminated - Clinical trials for Rheumatoid Arthritis

A Rheumatoid Arthritis Study in Participants on a Background Treatment of Methotrexate

FLEX M
Start date: December 2010
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to help answer if LY2127399 is safe and effective in the treatment of rheumatoid arthritis while on a background treatment of methotrexate. This study is comprised of 3 periods: Period 1: 52-week blinded treatment Period 2: additional 48-week unblinded treatment Period 3: 48-week post-treatment follow-up

NCT ID: NCT01163253 Terminated - Psoriasis Clinical Trials

A Long Term Study To Evaluate The Safety And Tolerability Of CP-690,550 For Patients With Moderate To Severe Chronic Plaque Psoriasis

Start date: September 2010
Phase: Phase 3
Study type: Interventional

The main objective of this study is to evaluate the long-term safety of CP-690,550 in patients being treated for moderate to severe chronic plaque psoriasis. This is an open label extension study available to patients who participated in one of the qualifying studies with CP-690,550 providing entry criteria is met.

NCT ID: NCT01151215 Terminated - Breast Cancer Clinical Trials

Study of Anastrozole +/- AZD8931 in Postmenopausal Women With Endocrine Therapy Naive Breast Cancer

MINT
Start date: June 2010
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to compare progression free survival in patients treated with AZD8931 given in combination with anastrozole versus anastrozole alone. The secondary objective is to investigate the safety and tolerability of AZD8931 given in combination with anastrozole.

NCT ID: NCT01151137 Terminated - Atrial Fibrillation Clinical Trials

Permanent Atrial fibriLLAtion Outcome Study Using Dronedarone on Top of Standard Therapy

PALLAS
Start date: July 2010
Phase: Phase 3
Study type: Interventional

Primary Objective: - Demonstrate the efficacy of Dronedarone in preventing major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or unplanned cardiovascular hospitalization or death from any cause in patients with permanent Atrial Fibrillation [AF] and additional risk factors Secondary Objective: - Demonstrate the efficacy of Dronedarone in preventing cardiovascular death This was an event-driven study where a common study end date [CSED] was to be determined by Steering Committee based on the number of events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death).

NCT ID: NCT01133990 Terminated - Colorectal Cancer Clinical Trials

FOLFIRI Alone Versus FOLFIRI Plus Bevacizumab Versus FOLFIRI Plus E7820 as Second-Line Therapy in Patients With Locally Advanced or Metastatic Colorectal Cancer

Start date: March 4, 2010
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the Phase Ib portion is to find out the highest dose of study drug that can safely be given when tested in a small group of subjects. The purpose of the Phase II portion is to find out how safe the study drug is when taken at the highest dose in a larger group of subjects.

NCT ID: NCT01130246 Terminated - Clinical trials for Acute Coronary Syndrome

VISTA-16 Trial: Evaluation of Safety and Efficacy of Short-term A-002 Treatment in Subjects With Acute Coronary Syndrome

VISTA-16
Start date: May 2010
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the safety and efficacy of short-term A-002 treatment on morbidity and mortality when added to atorvastatin and standard of care in subjects with an acute coronary syndrome (ACS).

NCT ID: NCT01129674 Terminated - Schizophrenia Clinical Trials

A Long-Term, Open-Label, Study on Schizophrenia

Start date: June 2010
Phase: Phase 2/Phase 3
Study type: Interventional

The primary purpose of the study is to help answer the following research questions: How LY 2140023 can be tolerated by patients with Schizophrenia compared to standard of care treatment in 52 weeks time period. Whether LY 2140023 can help patients with Schizophrenia.