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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: 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: NCT01131351 Terminated - Tuberculosis Clinical Trials

Safety and Pharmacokinetics (PK) in Multidrug-Resistant (MDR) Refractive Tuberculosis

Start date: February 19, 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is: - To evaluate the safety and tolerability of orally administered OPC-67683 when administered two times daily to MDR tuberculosis (TB) participants refractory to treatment with an optimized background regimen of anti-TB medications (OBR). - To evaluate the pharmacokinetics (PK) of OPC-67683 and metabolites.

NCT ID: NCT01118728 Terminated - Clinical trials for Ankylosing Spondylitis

Extension Study for Long Term Evaluation of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis

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

Primary Objective: - To assess the long term safety of Sarilumab (SAR153191/REGN88) in patients with ankylosing spondylitis (AS) Secondary Objective: - To assess the long term efficacy of Sarilumab (SAR153191/REGN88) in patients with AS

NCT ID: NCT01110421 Terminated - Clinical trials for Pneumonia, Bacterial

A Safety and Tolerability Study of Doripenem Compared With Cefepime in Hospitalized Children With Bacterial Pneumonia

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

The purpose of this study is to evaluate the safety and tolerability of doripenem compared to cefepime in children hospitalized with pneumonia.

NCT ID: NCT01110408 Terminated - Clinical trials for Complicated Urinary Tract Infections or Pyelonephritis

A Safety and Tolerability Study of Doripenem Compared With Cefepime in Children Hospitalized With Complicated Urinary Tract Infections

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

The purpose of this study is to evaluate the safety and tolerability of doripenem compared to cefepime in children hospitalized with complicated urinary tract infections.

NCT ID: NCT01110382 Terminated - Infection Clinical Trials

A Safety and Tolerability Study of Doripenem Compared With Meropenem in Children Hospitalized With Complicated Intra-abdominal Infections

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

The purpose of the study is to evaluate the safety and tolerability of doripenem compared with meropenem in children hospitalized with complicated intra-abdominal infections.

NCT ID: NCT01047319 Terminated - Clinical trials for Relapsing Multiple Sclerosis

A Study to Evaluate the Long-term Safety, Tolerability and Effect of Daily Oral Laquinimod 0.6 mg on Disease Course in Subjects With Relapsing Multiple Sclerosis

Start date: May 27, 2010
Phase: Phase 3
Study type: Interventional

To make laquinimod 0.6 mg available for all subjects who completed the placebo-controlled MS-LAQ-302 study according to the protocol and to evaluate the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6 mg in subjects with relapsing multiple sclerosis.