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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: NCT01211665 Terminated - Clinical trials for Immune Reconstitution Inflammatory Syndrome

Corticosteroids for Immune Reconstitution Inflammatory Syndrome (IRIS)

IRIS
Start date: September 2010
Phase: Phase 4
Study type: Interventional

The objectives of this study are to explore the effects of administering high-dose corticosteroids to participants who developed progressive multifocal leukoencephalopathy (PML) while on natalizumab as measured by time-course change in functional status based on Karnofsky Performance Status Index through 6 months following the completion of plasma exchange (PLEX; or equivalent), survival at 6 months following the completion of PLEX (or equivalent), and incidence and severity of adverse events (AEs) and serious adverse events (SAEs); to characterize the evolution of immune reconstitution inflammatory syndrome (IRIS) as measured by time course changes in Global Clinical Impression of Improvement (GCI-I), Symbol Digit Modalities Test (SDMT), brain magnetic resonance imaging (MRI), magnetoencephalography (MEG), chemokines, cytokines, C-reactive protein (CRP), John Cunningham virus (JCV) load and cell count in cerebrospinal fluid (CSF); and to characterize the time course elimination of serum natalizumab concentrations in the study population following the last PLEX (or equivalent) procedure.

NCT ID: NCT01211639 Terminated - Clinical trials for Progressive Multifocal Leukoencephalopathy

Genetic Evaluation of Natalizumab-Treated Patients With Progressive Multifocal Leukoencephalopathy

Start date: October 2010
Phase: N/A
Study type: Observational

The purpose of this study is to explore host genetic mutations which may render individual subjects more susceptible (or resistant) to developing Progressive Multifocal Leukoencephalopathy (PML). Samples will also be collected to determine Deoxyribonucleic Acid (DNA) sequence of JC Virus (JCV). Analysis of the JC Virus (JCV) genome may provide information about viral genotypes that may be associated with higher pathogenicity, and help to identify individuals who may be at higher risk of developing Progressive Multifocal Leukoencephalopathy (PML) due to chronic infection with a more pathogenic variant of JC Virus (JCV).

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: NCT01209390 Terminated - Clinical trials for Osteochondral Defects

A Prospective, Post-marketing Registry on the Use of ChondroMimetic for the Repair of Osteochondral Defects

OMCM
Start date: September 2010
Phase: N/A
Study type: Observational

The objective of this post-marketing study is to confirm the clinical efficacy and safety outcome of treatment with ChondroMimetic in a patient population within the proposed indication (osteochondral cartilage defects), over a 36 months post-implantation follow-up period. The primary objective is to collect post-marketing safety data in a real life setting by means of (S)ADR reporting. The secondary objectives are: - Clinical outcome as assessed by patient reported EuroQoL-5D - Structural repair as assessed by MRI - The number of treatment failures and the time to treatment failure - The ease of use of ChondroMimetic as reported by the surgeon

NCT ID: NCT01208233 Terminated - Ischemic Stroke Clinical Trials

Study Evaluating The Safety And Efficacy Of PF-03049423 In Subjects With Ischemic Stroke

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

The purpose of this study is to evaluate the safety and tolerability of PF-03049423 following multiple dose administration to subjects with ischemic stroke. The study will also evaluate the efficacy of PF-03049423, relative to placebo, in subjects with ischemic stroke following 90 days of therapy. The study will also explore the relationship between PF-03049423 concentration and blood pressure.

NCT ID: NCT01208064 Terminated - Lung Cancer Clinical Trials

Pazopanib Hydrochloride or a Placebo in Treating Patients With Non-Small Cell Lung Cancer Who Have Received First-Line Chemotherapy

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

RATIONALE: Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether pazopanib hydrochloride is more effective than a placebo in treating patients with non-small cell lung cancer that has not progressed after first-line chemotherapy. PURPOSE: This randomized phase II/III trial is studying how well giving pazopanib hydrochloride works and compares it with giving a placebo in treating patients with non-small cell lung cancer who have received first-line chemotherapy.

NCT ID: NCT01207973 Terminated - Osteoarthritis Clinical Trials

Safety, Tolerability, Pharmacokinetics and -Dynamics of Multiple Rising Oral Doses of BI 113823 in Patients Patients With Osteoarthritis of the Knee

Start date: September 2010
Phase: Phase 1
Study type: Interventional

The objective of the study is to investigate the safety and tolerability of BI 113823 in male and female patients with osteoarthritis, following oral administration of BI 113823 with repeated rising doses.

NCT ID: NCT01203254 Terminated - Crohns Disease Clinical Trials

Colesevelam for the Treatment of Bile Acid Malabsorption in Patients With Crohn's Disease

COBAM
Start date: October 2010
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess the efficacy of cholestagel to reduce the frequency of soft and liquid stools per day in patients with CD in clinical remission with symptoms of BAM and to assess the improvement in stool consistency and quality of life in these patients and to assess the safety of cholestagel.