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Study Evaluating Etanercept in the Treatment of Subjects With Ankylosing Spondylitis

2014-07-23 21:30:11 | BioPortfolio

Summary

This study will represent the sponsor's first controlled study of etanercept in Chinese subjects with Ankylosing Spondytitis (AS). This trial is designed to assess the safety and efficacy of etanercept compared to placebo in the treatment of patients with AS.

Description

Multicenter, double-blind, randomized, parallel and placebo-controlled outpatient study. The study consists of 2 parts: part A is a 6-week double-blind treatment period and part B is a 6-week open-label treatment period. During part A of the study, subjects will be randomly assigned to 1 of 2 treatment regimens: 2 etanercept 25 mg or placebo once weekly, administered subcutaneously (SC). After the completion of part A, all subjects will receive 2 etanercept 25 mg once weekly. The use of placebo as a control in part A is necessary to allow a valid comparison and to provide a quantitative assessment of effect.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Ankylosing Spondylitis

Intervention

Enbrel (etanercept)

Status

Completed

Source

Wyeth

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:30:11-0400

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An Open-Label Multicentre Long-Term Extension Study of Etanercept for Ankylosing Spondylitis

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Study Evaluating Etanercept for the Treatment of Active, Severe, and Advanced Axial Ankylosing Spondylitis

Evaluation of the efficacy and safety of etanercept (Enbrel) in patients with active, severe and advanced ankylosing spondylitis.

Study Evaluating Enbrel (Etanercept) in Patients With Ankylosing Spondylitis

The purpose of this study is to investigate the incidence of adverse events for patients with AS treated with Enbrel in usual care settings.

PubMed Articles [132 Associated PubMed Articles listed on BioPortfolio]

Etanercept for Ankylosing Spondylitis With Coexisting Demyelinating Myelitis.

Etanercept-induced Crohn's disease in ankylosing spondylitis: a case report and review of the literature.

Tumor necrosis factor (TNF)-α is a cytokine that plays a well-established, key role as a central mediator of inflammation and immune regulation. TNF-α and its receptors are suggested to play a criti...

The Safety Profile of Tumor Necrosis Factor Inhibitors in Ankylosing Spondylitis: Are TNF Inhibitors Safer Than We Thought?

Tumor necrosis factor (TNF) inhibitors significantly improved the treatment options for patients with ankylosing spondylitis. Unfortunately, currently, there is no strategy for sustaining remission of...

Biomechanical properties of low back myofascial tissue in younger adult ankylosing spondylitis patients and matched healthy control subjects.

Ankylosing spondylitis is a degenerative and inflammatory rheumatologic disorder that primarily affects the spine. Delayed diagnosis leads to debilitating spinal damage. This study examines biomechani...

Influence of HLA-B27 on the Ankylosing Spondylitis phenotype: results from the REGISPONSER database.

To assess HLA-B27 influence on the clinical phenotype of Ankylosing Spondylitis (AS) patients.

Medical and Biotech [MESH] Definitions

A recombinant version of soluble human TNF receptor that binds specifically to TUMOR NECROSIS FACTOR and inhibits its binding with endogenous TNF receptors. It prevents the inflammatory effect of TNF and is used to treat RHEUMATOID ARTHRITIS; PSORIATIC ARTHRITIS and ANKYLOSING SPONDYLITIS.

A chimeric monoclonal antibody to TNF ALPHA that is used in the treatment of RHEUMATOID ARTHRITIS; ANKYLOSING SPONDYLITIS; PSORIATIC ARTHRITIS and CROHN'S DISEASE.

A butyl-diphenyl-pyrazolidinedione that has anti-inflammatory, antipyretic, and analgesic activities. It has been used in ANKYLOSING SPONDYLITIS; RHEUMATOID ARTHRITIS; and REACTIVE ARTHRITIS.

A nonsteroidal anti-inflammatory agent with potent analgesic and antiarthritic properties. It has been shown to be effective in the treatment of OSTEOARTHRITIS; RHEUMATOID ARTHRITIS; ankylosing SPONDYLITIS; and in the alleviation of postoperative pain (PAIN, POSTOPERATIVE).

Human histocompatibility (HLA) surface antigen encoded by the B locus on chromosome 6. It is strongly associated with acute anterior uveitis (UVEITIS, ANTERIOR); ANKYLOSING SPONDYLITIS; and REACTIVE ARTHRITIS.

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