Study Evaluating Etanercept in the Treatment of Subjects With Ankylosing Spondylitis

This study has been completed.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer Identifier:
First received: February 9, 2007
Last updated: December 11, 2007
Last verified: December 2007
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.

Condition Intervention Phase
Ankylosing Spondylitis
Drug: Enbrel (etanercept)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Multicenter, Double-Blind, Placebo-Controlled, Randomized Phase III Study of Etanercept in the Treatment of Subjects With Ankylosing Spondylitis

Resource links provided by NLM:

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Assessment in Ankylosing Spondylitis (ASAS) response criteria 20% at week six.

Secondary Outcome Measures:
  • ASAS 20% response at all visits except week two. ASAS 50%, 70%, 40%, 5/6 responses at all visits.

Estimated Enrollment: 150
Study Start Date: February 2007
Study Completion Date: June 2007
Detailed 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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Must be of Chinese ancestry and living in China.
  2. Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis.
  3. Active AS at time of enrollment, defined by average of visual analog scale (VAS) values for duration and intensity of morning stiffness 30 and two of the following: VAS for patient global assessment 30; average of VAS for nocturnal and total pain 30; BASFI greater than or equal to 30 (all scores on a scale of 0 to 100).

Exclusion Criteria:

  1. Complete ankylosis (fusion) of spine.
  2. Previous treatment with etanercept, antibody to Tumor Necrosis Factor a (TNFa), or other TNFa inhibitors or other biologic agents.
  3. Use of disease modifying antirheumatic drugs (DMARDs) other than hydroxychloroquine, sulphasalazine, and methotrexate within 4 weeks of baseline. Subjects treated with hydroxychloroquine, sulphasalazine, and methotrexate may continue these drugs during this study but doses must be held stable for 4 weeks before baseline examination and for the duration of the study.
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Please refer to this study by its identifier: NCT00434044

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided Identifier: NCT00434044     History of Changes
Other Study ID Numbers: 0881A3-322 
Study First Received: February 9, 2007
Last Updated: December 11, 2007
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Spondylitis, Ankylosing
Bone Diseases
Bone Diseases, Infectious
Joint Diseases
Musculoskeletal Diseases
Spinal Diseases
TNFR-Fc fusion protein
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on February 08, 2016