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Study Evaluating Etanercept Treatment of Patients With Ankylosing Spondylitis

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00421915
First received: January 8, 2007
Last updated: January 12, 2007
Last verified: January 2007

January 8, 2007
January 12, 2007
March 2002
Not Provided
  • To compare the efficacy of etanercept (25 mg, twice weekly) with that of placebo based on the
  • percentage of patients who achieved the assessment in Ankylosing Spondylitis (ASAS 20%) response criteria at week 12.
Same as current
Complete list of historical versions of study NCT00421915 on ClinicalTrials.gov Archive Site
  • To assess: 1) the safety of etanercept in this patient population; 2) the efficacy of etanercept
  • compared with that of placebo using the ASAS response criteria at 50% and 70% levels at week 12.
Same as current
Not Provided
Not Provided
 
Study Evaluating Etanercept Treatment of Patients With Ankylosing Spondylitis
Multicenter, Double-Blind, Parallel, Placebo-Controlled, Randomised Phase 3 Study of Etanercept in the Treatment of Patients With Ankylosing Spondylitis: 12-Week Final Data

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 Spondylitis (ASAS) response criteria (ASAS 20%) at week 12.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Ankylosing Spondylitis
Drug: Enbrel (etanercept)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
August 2002
Not Provided

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00421915
0881A3-311
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP