Status:
COMPLETED
Study Evaluating Etanercept Treatment of Patients With Ankylosing Spondylitis
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Ankylosing Spondylitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The primary objective of the study was to compare the efficacy of etanercept (25 mg, twice weekly) with that of placebo based on the percentage of patients who achieve the Assessment in Ankylosing Spo...
Eligibility Criteria
Inclusion
- Main inclusion criteria
- Diagnosis of AS (defined by Modified New York Criteria for Ankylosing Spondylitis).
- Active AS (defined by the average of scores on the visual analog scale \[VAS\] of ≥ 30 for duration and intensity of morning stiffness and by 2 of the following: VAS for patient global assessment ≥ 30; average of VAS for nocturnal and total pain ≥ 30; BASFI ≥ 30 (all scores on a scale of 0 to 100).
- 18 to 70 years of age.
- Main exclusion criteria
- Complete ankylosis (fusion) of spine.
- Previous receipt of etanercept, antibody to tumour necrosis factor alpha (TNFα), or other TNFα inhibitors.
- Use of disease-modifying antirheumatic drugs (DMARDs) other than hydroxychloroquine, sulphasalazine, or methotrexate within 4 weeks of baseline.
Exclusion
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
End Date :
August 1 2002
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00421915
Start Date
March 1 2002
End Date
August 1 2002
Last Update
January 15 2007
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