Study Comparing Etanercept 50 mg Once Weekly to 25 mg Twice Weekly in Patients With Ankylosing Spondylitis

Ankylosing Spondylitis Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo Controlled Trial Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly Compared With 25 mg Twice Weekly in Subjects With Ankylosing Spondylitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00418548
• Other study ID #: 0881A3-314
• Status: Completed
• Phase: Phase 3
• First received: January 4, 2007
• Last updated: January 4, 2007
• Start date: June 2004
• Est. completion date: February 2005

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: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare efficacy, pharmacokinetics, and safety of investigational formulations of etanercept administered as 50 mg once weekly with 25 mg twice weekly and placebo in patients with ankylosing spondylitis (AS).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis.

• Active AS, defined by average of visual analog scale (VAS) of = 30 for duration and intensity of morning stiffness and at least 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).

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.

• Receipt of multiple nonsteroidal anti-inflammatory drugs (NSAIDs) at baseline.

• Dose of NSAID changed within 2 weeks of baseline evaluation.

• Dose of prednisone >10 mg/day (or equivalent) or changed within 2 weeks of baseline evaluation.

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:
• 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	The primary objective is to assess the efficacy (measured by % of subjects achieving ASAS 20 (Assessments in Ankylosing Spondylitis 20%) at week 12) and safety of etanercept 50 mg once weekly.