Study Evaluating Etanercept Treatment of Patients With Ankylosing Spondylitis

Ankylosing Spondylitis Clinical Trial

Official title:

Multicenter, Double-Blind, Parallel, Placebo-Controlled, Randomised Phase 3 Study of Etanercept in the Treatment of Patients With Ankylosing Spondylitis: 12-Week Final Data

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00421915
• Other study ID #: 0881A3-311
• Status: Completed
• Phase: Phase 3
• First received: January 8, 2007
• Last updated: January 12, 2007
• Start date: March 2002
• Est. completion date: August 2002

Study information

• Verified date: January 2007
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: August 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 (TNFa), or other TNFa inhibitors.

• Use of disease-modifying antirheumatic drugs (DMARDs) other than hydroxychloroquine, sulphasalazine, or methotrexate within 4 weeks of baseline.

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	To compare the efficacy of etanercept (25 mg, twice weekly) with that of placebo based on the
Primary	percentage of patients who achieved the assessment in Ankylosing Spondylitis (ASAS 20%) response criteria at week 12.
Secondary	To assess: 1) the safety of etanercept in this patient population; 2) the efficacy of etanercept
Secondary	compared with that of placebo using the ASAS response criteria at 50% and 70% levels at week 12.