Status:

COMPLETED

Study Evaluating Etanercept for the Treatment of Active, Severe, and Advanced Axial Ankylosing Spondylitis

Lead Sponsor:

Wyeth is now a wholly owned subsidiary of Pfizer

Conditions:

Ankylosing Spondylitis

Eligibility:

All Genders

18-70 years

Phase:

PHASE4

Brief Summary

Evaluation of the efficacy and safety of etanercept (Enbrel) in patients with active, severe and advanced ankylosing spondylitis.

Eligibility Criteria

Inclusion

  • Inclusion criteria
  • Active and severe ankylosing spondylitis
  • Ankylosing spondylitis refractory to standard anti-rheumatic treatment
  • Between 18 and 70 years of age
  • Exclusion criteria
  • Prior exposure to any TNF-inhibitor, including etanercept
  • DMARDs (other than hydroxychloroquine, methotrexate and sulphasalazine) within 4 weeks of study drug initiation
  • Dose of NSAIDs changed within two weeks of study drug initiation

Exclusion

    Key Trial Info

    Start Date :

    January 1 2007

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    May 1 2009

    Estimated Enrollment :

    82 Patients enrolled

    Trial Details

    Trial ID

    NCT00420238

    Start Date

    January 1 2007

    End Date

    May 1 2009

    Last Update

    June 29 2010

    Active Locations (21)

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    Page 1 of 6 (21 locations)

    1

    Amiens, France, 80094

    2

    Arles, France, 13200

    3

    Avignon, France, 84000

    4

    Bordeaux, France, 33076