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| Sponsor: | Wyeth |
|---|---|
| Information provided by: | Wyeth |
| ClinicalTrials.gov Identifier: | NCT00247962 |
Purpose
The purpose of this study is to compare the efficacy of etanercept and sulphasalazine in the treatment of Ankylosing Spondylitis.
| Condition | Intervention | Phase |
|---|---|---|
|
Ankylosing Spondylitis |
Drug: etanercept Drug: sulphasalazine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Randomized, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects With Ankylosing Spondylitis |
| Estimated Enrollment: | 540 |
| Study Start Date: | December 2005 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| A: Experimental |
Drug: etanercept
50mg
|
| B: Active Comparator |
Drug: sulphasalazine
Sulphasalazine: The target dose for SSZ is 1.5g (3 tablets) twice daily orally. Subject start the oral TA at 0.5g daily for the first week and increase by 0.5g every week until a daily dose of 3g. Is achieved by the start of study week 5 of the study.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| Australia, Victoria | |
| Heidelberg West, Victoria, Australia, 3081 | |
| Australia, Western Australia | |
| Shenton Park, Western Australia, Australia, 6000 | |
| Austria | |
| Innsbruck, Austria, 6020 | |
| Linz, Austria, A-4020 | |
| Klagenfurt, Austria, A-9020 | |
| China | |
| Beijing, China, 100853 | |
| Shanghai, China, 200001 | |
| Czech Republic | |
| Praha, Czech Republic, 120 00 | |
| Ostrava, Czech Republic, 722 00 | |
| Denmark | |
| Frederiksberg, Denmark, DK-2000 | |
| Vejle, Denmark, 7100 | |
| Odense, Denmark, 5000 | |
| Kolding, Denmark, 6000 | |
| Finland | |
| Helsinki, Finland, 00029 | |
| Kuopio, Finland, 70211 | |
| Tampere, Finland, 33100 | |
| France | |
| Orleans, France, 45032 | |
| Creteil, France, 94010 | |
| Amiens, France, 80054 | |
| Toulouse, France, 31059 | |
| Marseille, France, 13005 | |
| Bordeaux, France, 33076 | |
| Pierre Mendès, France, 76290 | |
| Boulogne Billancourt, France, 92104 | |
| Nantes, France, 44000 | |
| Germany | |
| Herne, Germany, D-44652 | |
| Hamburg, Germany, D-22081 | |
| Wiesbaden, Germany, D-65191 | |
| Berlin, Germany, 12200 | |
| Erlangen, Germany, D-91054 | |
| Ratingen, Germany, D-40882 | |
| Hildesheim, Germany, D-31134 | |
| Heubnerweg, Germany, D-14059 | |
| Muenchen, Germany, D-80639 | |
| Pirna, Germany, D-01796 | |
| Berlin, Germany, D-10117 | |
| Gommern, Germany, D-39245 | |
| Wiesbaden, Germany, 65185 | |
| Hungary | |
| Gyor, Hungary, 9025 | |
| Pecs, Hungary, 7621 | |
| Szeged, Hungary, 6724 | |
| Nyiregyhaza, Hungary, 4400 | |
| Debrecen, Hungary, 4043 | |
| Ireland | |
| Dublin, Ireland | |
| Ireland, Cork | |
| Wilton, Cork, Ireland | |
| Italy | |
| Prato, Italy, 59100 | |
| Benevento, Italy, 82037 | |
| Reggio Emilia, Italy, 42100 | |
| Bergamo, Italy, 24128 | |
| Monserrato, Italy, 09042 | |
| Potenza, Italy, 85100 | |
| Roma, Italy, 00161 | |
| Firenze, Italy, 50143 | |
| Roma, Italy, 00189 | |
| Netherlands | |
| Amsterdam, Netherlands, 1081 HV | |
| Maastricht, Netherlands, 6229HX | |
| Nijmegen, Netherlands, 6522JV | |
| Groningen, Netherlands, 9713GZ | |
| Leeuwarden, Netherlands, 8934AD | |
| Poland | |
| Ustron Zawodzie, Poland, 43-450 | |
| Warszawa, Poland, 02-637 | |
| Wroclaw, Poland, 53-137 | |
| Lodz, Poland, 93-513 | |
| Qatar | |
| Doha, Qatar, 3050 | |
| Saudi Arabia | |
| Riyadh, Saudi Arabia, 11426 | |
| Spain | |
| Tenerife, Spain, 38010 | |
| Asturias, Spain, 33012 | |
| Cordoba, Spain, 14004 | |
| Barcelona, Spain, 08003 | |
| Madrid, Spain, 28035 | |
| Madrid, Spain, 28922 | |
| Porto, Spain, 4200-319 | |
| Spain, Barcelona | |
| Granollers, Barcelona, Spain, 08400 | |
| Sweden | |
| Solna, Sweden, 17176 | |
| Ostra kyrkogardsgatan, Sweden, 59333 | |
| United Kingdom | |
| Newcastle Upon Tyne, United Kingdom, NE7 7DN | |
| Cambridge, United Kingdom, CB2 2QQ | |
| Upper Borough Walls, United Kingdom, BA1 1RL | |
| Cannock, United Kingdom, WS11 2XY | |
| Liverpool, United Kingdom, L9 7AL | |
| Basingstoke, United Kingdom, RG24 9NA | |
| Glasgow, United Kingdom, G31 2ER | |
| United Kingdom, Wirral | |
| Upton, Wirral, United Kingdom, L49 5PE | |
| Study Director: | Medical Monitor | Wyeth |
| Principal Investigator: | Trial Manager | For Poland, WPWZMED@wyeth.com |
| Principal Investigator: | Trial Manager | For Italy, descresg@wyeth.com |
| Principal Investigator: | Trial Manager | For Hungary, WPBUMED@wyeth.com |
| Principal Investigator: | Trial Manager | For Czech Republic, WPPGCLI@wyeth.com |
| Principal Investigator: | Trial Manager | For Australia, medinfo@wyeth.com |
| Principal Investigator: | Trial Manager | For Germany, medinfoDEU@wyeth.com |
| Principal Investigator: | Trial Manager | For Austria, WPVIMED@wyeth.com |
| Principal Investigator: | Trial Manager | For Spain, infomed@wyeth.com |
| Principal Investigator: | Trial Manager | For Netherlands, trials-NL@wyeth.com |
| Principal Investigator: | Trial Manager | For Denmark, medinfonord@wyeth.com |
| Principal Investigator: | Trial Manager | For Finland, MedInfoNord@wyeth.com |
| Principal Investigator: | Trial Manager | For Sweden, MedInfoNord@wyeth.com |
| Principal Investigator: | Trial Manager | For UK/Great Britian, ukmedinfo@wyeth.com |
| Principal Investigator: | Trial Manager | For Ireland, ukmedinfo@wyeth.com |
| Principal Investigator: | Trial Manager | For France, infomedfrance@wyeth.com |
| Principal Investigator: | Trial Manager | For China, medinfo@wyeth.com |
More Information
| Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
| Study ID Numbers: | 0881A3-402 |
| Study First Received: | October 31, 2005 |
| Last Updated: | July 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00247962 History of Changes |
| Health Authority: | European Union: European Medicines Agency |
|
Ankylosing Spondylitis (AS) |
|
Anti-Inflammatory Agents Anti-Infective Agents Immunologic Factors Sulfasalazine Physiological Effects of Drugs Infection TNFR-Fc fusion protein Bone Diseases Musculoskeletal Diseases Sensory System Agents Arthritis Therapeutic Uses Spondylitis, Ankylosing Anti-Inflammatory Agents, Non-Steroidal Analgesics |
Spondylarthritis Spondylitis Ankylosis Spondylarthropathies Spinal Diseases Joint Diseases Gastrointestinal Agents Immunosuppressive Agents Pharmacologic Actions Bone Diseases, Infectious Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |
