Study Evaluating Etanercept in Patients With Ankylosing Spondylitis

Overview

This study will assess the efficacy of etanercept for the treatment of Ankylosing Spondylitis (AS).

Full Title of Study: “Multicentre, Open-Labeled Study Of Etanercept In The Treatment Of Patients With Ankylosing Spondylitis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)

Interventions

  • Drug: etanercept

Clinical Trial Outcome Measures

Primary Measures

  • To determine the efficacy of etanercept (25 mg, twice weekly) based on the percentage of patients who achieve the Assessment in Ankylosing Spondylitis (ASAS) Response Criteria at 20% level at week 12.

Secondary Measures

  • Efficacy at 50% and 70% levels week 12; frequency and time to partial remission; safety; patient and physician global assessment, nocturnal and total back pain, BASFI, BASDAI; spinal mobility; complete joint assessment; hip involvement; ESR, CRP.

Participating in This Clinical Trial

Inclusion Criteria

  • Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis, aged between 18 and 70 years of age. – BASDAI greater than or equal to 40 (all scores on a scale of 0 to 100). – Negative result of serum human chorionic gonadotropin (HCG) pregnancy test taken at screening in all women except those surgically sterile or at least 1 year postmenopausal. Exclusion Criteria:

  • Complete ankylosis (fusion) of spine. – Previous receipt of etanercept, antibody to TNFα, or other TNFα inhibitors. – Use of disease modifying antirheumatic drugs (DMARDs) other than hydroxychloroquine, sulphasalazine, and methotrexate within 4 weeks of baseline. Patients 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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Wyeth is now a wholly owned subsidiary of Pfizer
  • Overall Official(s)
    • Medical Monitor, Study Director, Wyeth is now a wholly owned subsidiary of Pfizer

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