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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: NCT01209702 Terminated - Clinical trials for Spondylitis, Ankylosing

A Study of RoActemra/Actemra (Tocilizumab) in Patients With Ankylosing Spondylitis Who Have Failed Treatment With NSAIDs

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

This randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with ankylosing spondylitis (AS) who have failed treatment with non-steroidal anti-inflammatory drugs and are naïve to tumor necrsos factor (TNF) antagonist therapy. In Part 1 of the study, patients will be randomized to receive either RoActemra/Actemra 8 mg/kg intravenously (IV) or placebo every 4 weeks for 12 weeks. In Part 2, patients will be randomized to receive RoActemra at either 8 mg/kg or 4 mg/kg IV or placebo every 4 weeks for 24 weeks. The double-blind treatment period will be followed by open-label treatment with RoActemra/Actemra 8 mg/kg iv every 4 weeks until Week 208 for all patients. Anticipated time on study treatment is 208 weeks.

NCT ID: NCT01209689 Terminated - Clinical trials for Spondylitis, Ankylosing

A Study of Tocilizumab (RoActemra/Actemra) in Patients With Ankylosing Spondylitis Who Have Had an Inadequate Response to Previous Tumor Necrosis Factor (TNF) Antagonist Therapy

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

This randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of tocilizumab (RoActemra/Actemra) in patients with ankylosing spondylitis (AS) who had an inadequate response to previous tumor necrosis factor (TNF) antagonist therapy. Patients were randomized to receive tocilizumab at a dose of either 8 mg/kg or 4 mg/kg intravenously (iv) or placebo every 4 weeks for 24 weeks. The double-blind treatment period was followed by open-label treatment with tocilizumab 8 mg/kg iv every 4 weeks until Week 104 for all patients. This study and all further clinical development of tocilizumab AS was halted after a review of 12-week data from Study NA22823, a randomized double-blind, placebo-controlled study in TNF antagonist naïve AS patients, failed to demonstrate efficacy.

NCT ID: NCT01202773 Terminated - Clinical trials for Rheumatoid Arthritis

A Study in Participants With Rheumatoid Arthritis

FLEX V
Start date: January 2011
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 in participants with an inadequate response to one or more tumor necrosis factor-alpha (TNF-α) inhibitors. This study is comprised of 2 periods: Period 1: 24-week blinded treatment Period 2: 48-week post-treatment follow-up

NCT ID: NCT01202058 Terminated - Clinical trials for Atherosclerotic Coronary Artery Disease

An Observational Safety Evaluation of Patients Treated With the NEVO™ Sirolimus-eluting Coronary Stent. (NEVO II)

NEVO II
Start date: August 2010
Phase: Phase 3
Study type: Interventional

As a result of the implementation of Protocol Am3.0, the design and objective of the NEVO II trial were changed to focus on the safety follow-up of the 103 NEVO™ subjects. Although this trial started interventional, the remainder of the study will be observational. The objective of this prospective, observational study is to ensure the safety and the wellbeing of subjects treated with the NEVO™ SES.

NCT ID: NCT01199302 Terminated - Crohn's Disease Clinical Trials

Long-term Safety Study of Brodalumab in Adults With Crohn's Disease

Start date: February 2, 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of long-term treatment with brodalumab in adults with Crohn's disease.

NCT ID: NCT01198054 Terminated - AML Clinical Trials

LENA-LMA-5:Lenalidomide in Acute Myeloid Leukemia (AML)

Start date: January 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the effectiveness of post-induction lenalidomide in patients with de novo AML with deletion 5q cytogenetic abnormality (del (5q)) or monosomy 5 (-5), who obtained complete remission after conventional induction chemotherapy. So, too, for those who no obtained response treatment (total resistance) or partial remission. At the same time, the study evaluate the security of lenalidomide.

NCT ID: NCT01195779 Terminated - Influenza Clinical Trials

Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children

Start date: September 30, 2010
Phase: Phase 2
Study type: Interventional

The purpose of this observer-blind study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' influenza vaccine GSK2584786A in healthy children 6 to 35 months of age.

NCT ID: NCT01193400 Terminated - Clinical trials for Acute Myelogenous Leukemia

Clofarabine and Low-dose Cytarabine Followed by Consolidation Therapy in AML Patients Age Greater Than or Equal to 60 Years

Start date: September 2010
Phase: Phase 2
Study type: Interventional

Primary outcome measure: Evaluate the efficacy in terms of complete responses of induction therapy and first-line consolidation of Clofarabine and low-dose Cytarabine with AML patients aged 60 years or more. The first efficacy objective is evaluate the overall remission rate (TRG), where general reference (RG) is defined as a patient who achieved complete remission (CR) or complete remission with inadequate platelet recovery (CPR). Secondary outcome measures: - To evaluate disease-free survival (DFS) - Evaluate the overall survival (OS) - To evaluate the safety and tolerability of clofarabine and duration, severity and relationship of adverse events (AEs) occurring during treatment - To assess the rate of mortality at 30 days (ie, the incidence of deaths occurring between Day 1 and Day 30 of induction cycle) - The incidence, intensity (according to the latest version of the CTCAE classification), duration, causality, severity and type of AA

NCT ID: NCT01189253 Terminated - Sarcoma Clinical Trials

Doxorubicin Hydrochloride or Trabectedin in Treating Patients With Previously Untreated Advanced or Metastatic Soft Tissue Sarcoma

Start date: May 2011
Phase: Phase 2/Phase 3
Study type: Interventional

RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride and trabectedin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether trabectedin is more effective than doxorubicin hydrochloride in treating patients with advanced or metastatic soft tissue sarcoma. PURPOSE: This randomized phase II/III trial is studying the safety of trabectedin compared with doxorubicin hydrochloride and to see how well they work in treating patients with advanced or metastatic soft tissue sarcoma.