Study Evaluating Etanercept in the Treatment of Subjects With Ankylosing Spondylitis

Ankylosing Spondylitis Clinical Trial

Official title:

Multicenter, Double-Blind, Placebo-Controlled, Randomized Phase III Study of Etanercept in the Treatment of Subjects With Ankylosing Spondylitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00434044
• Other study ID #: 0881A3-322
• Status: Completed
• Phase: Phase 3
• First received: February 9, 2007
• Last updated: December 11, 2007
• Start date: February 2007
• Est. completion date: June 2007

Study information

• Verified date: December 2007
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• Enbrel (etanercept)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment in Ankylosing Spondylitis (ASAS) response criteria 20% at week six.
Secondary	ASAS 20% response at all visits except week two. ASAS 50%, 70%, 40%, 5/6 responses at all visits.