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| Sponsored by: |
Wyeth |
|---|---|
| Information provided by: | Wyeth |
| ClinicalTrials.gov Identifier: | NCT00420303 |
Purpose
To assess the efficacy and safety of Etanercept in patients with spondylarthropathy and refractory heel enthesitis.
| Condition | Intervention | Phase |
|---|---|---|
|
Spondylarthropathies, Enthesitis |
Drug: Etanercept Other: Placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Multicentre, Double-Blind, Placebo-Controlled, Randomized Study of Etanercept in the Treatment of Adults Patients With Refractory Heel Enthesitis in Spondylarthropathy |
| Enrollment: | 20 |
| Study Start Date: | January 2007 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| A: Experimental |
Drug: Etanercept
50 mg injection once weekly
|
| B: Placebo Comparator |
Other: Placebo
placebo
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria
Exclusion criteria
Contacts and Locations| France | |
| Paris (COCHIN), France, 75679 | |
| Orleans, France, 45032 | |
| Paris (Saint Antoine), France, 75571 | |
| Limoges, France, 87042 | |
| Paris (Pitie Salpetriere), France, 75651 | |
| Avignon, France, 84000 | |
| Toulouse, France, 31000 | |
| Montpellier, France, 34295 | |
| Aulnay Sous Bois, France, 93602 | |
| Paris (Ambroise Pare), France, 92401 | |
| Nice, France, 6202 | |
| Grenoble, France, 38130 | |
| Arles, France, 13200 | |
| Paris (Lariboisiere), France, 75010 | |
| Paris (Bichat), France, 75018 | |
| Bordeaux, France, 33076 | |
| Strasbourg, France, 67098 | |
| Germany | |
| Berlin, Germany, 12200 | |
| Herne, Germany, 446652 | |
| Netherlands | |
| Maastricht, Netherlands, 6229 HX | |
| Study Director: | Medical Monitor | Wyeth |
| Principal Investigator: | Trial Manager | For France, infomedfrance@wyeth.com |
| Principal Investigator: | Trial Manager | For Germany, medinfoDEU@wyeth.com |
| Principal Investigator: | Trial Manager | For Netherlands, trials-NL@wyeth.com |
More Information
| Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
| Study ID Numbers: | 0881A3-404 |
| Study First Received: | January 8, 2007 |
| Last Updated: | December 1, 2008 |
| ClinicalTrials.gov Identifier: | NCT00420303 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency; France: Institutional Ethical Committee; Germany: Ethics Commission; Germany: Federal Institute for Drugs and Medical Devices; Netherlands: Independent Ethics Committee; Netherlands: Medicines Evaluation Board (MEB) |
|
Refractory Heel Enthesitis in Spondylarthropathy Spondylarthropathy Refractory Heel Enthesitis |
|
Spinal Diseases Musculoskeletal Diseases Spondylarthropathy Joint Diseases Arthritis |
TNFR-Fc fusion protein Bone Diseases Spondylarthritis Spondylarthropathies |
|
Anti-Inflammatory Agents Immunologic Factors Physiological Effects of Drugs Gastrointestinal Agents Immunosuppressive Agents Pharmacologic Actions Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |
