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Study Evaluating Etanercept in the Treatment of Subjects With Ankylosing Spondylitis

Primary Purpose

Ankylosing Spondylitis

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Enbrel (etanercept)

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Must be of Chinese ancestry and living in China.
Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis.
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:

Complete ankylosis (fusion) of spine.
Previous treatment with etanercept, antibody to Tumor Necrosis Factor a (TNFa), or other TNFa inhibitors or other biologic agents.
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.

Sites / Locations

Outcomes

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.

Full Information

NCT ID

NCT00434044

First Posted

February 9, 2007

Last Updated

December 11, 2007

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00434044

Brief Title

Study Evaluating Etanercept in the Treatment of Subjects With Ankylosing Spondylitis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2007

Overall Recruitment Status

Completed

Study Start Date

February 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ankylosing Spondylitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

150 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Enbrel (etanercept)

Primary Outcome Measure Information:

Title

Assessment in Ankylosing Spondylitis (ASAS) response criteria 20% at week six.

Secondary Outcome Measure Information:

Title

ASAS 20% response at all visits except week two. ASAS 50%, 70%, 40%, 5/6 responses at all visits.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Must be of Chinese ancestry and living in China. Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis. 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: Complete ankylosis (fusion) of spine. Previous treatment with etanercept, antibody to Tumor Necrosis Factor a (TNFa), or other TNFa inhibitors or other biologic agents. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Wyeth is now a wholly owned subsidiary of Pfizer

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

Study Evaluating Etanercept in the Treatment of Subjects With Ankylosing Spondylitis

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