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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

Page last updated: November 03, 2008

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