Study Evaluating Etanercept for the Treatment of Active, Severe, and Advanced Axial Ankylosing Spondylitis
Information source: Wyeth
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ankylosing Spondylitis
Intervention: Etanercept (Enbrel) (Drug); Placebo (Other)
Phase: Phase 4
Status: Recruiting
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Trial Manager, Principal Investigator, Affiliation: For France, infomedfrance@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Germany, medinfoDEU@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Netherlands, trials-NL@wyeth.com
Overall contact:
Trial Manager, Email: clintrialparticipation@wyeth.com
Summary
Evaluation of the efficacy and safety of etanercept (Enbrel) in patients with active, severe
and advanced ankylosing spondylitis.
Clinical Details
Official title: A Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients With Active, Severe, and Advanced Axial Ankylosing Spondylitis
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To compare the efficacy of etanercept with that of placebo in adults with active, severe and advanced axial ankylosing spondylitis
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Trial Manager, Email: clintrialparticipation@wyeth.com
Paris (COCHIN) 75679, France; Recruiting
Orleans 45032, France; Not yet recruiting
Paris (Saint Antoine) 75571, France; Recruiting
Limoges 87042, France; Not yet recruiting
Paris (Pitie Salpetriere) 75651, France; Recruiting
Paris (Ambroise Pare) 92401, France; Not yet recruiting
Toulouse 31000, France; Not yet recruiting
Montpellier 34295, France; Not yet recruiting
Aulnay Sous Bois 93602, France; Not yet recruiting
Avignon 84000, France; Recruiting
Nice 6202, France; Not yet recruiting
Grenoble 38130, France; Not yet recruiting
Arles 13200, France; Not yet recruiting
Paris (Lariboisiere) 75010, France; Not yet recruiting
Paris (Bichat) 75018, France; Recruiting
Bordeaux 33076, France; Not yet recruiting
Strasbourg 67098, France; Recruiting
Berlin 12200, Germany; Not yet recruiting
Herne 446652, Germany; Not yet recruiting
Maastricht 6229 HX, Netherlands; Not yet recruiting
Additional Information
Starting date: January 2007
Ending date: January 2010
Last updated: December 19, 2007
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