Study Evaluating Etanercept and Sulphasalazine in Ankylosing Spondylitis
This study has been completed.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00247962
First received: October 31, 2005
Last updated: October 9, 2012
Last verified: October 2012
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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 (SSZ) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects With Ankylosing Spondylitis |
Resource links provided by NLM:
Genetics Home Reference related topics:
ankylosing spondylitis
MedlinePlus related topics:
Ankylosing Spondylitis
U.S. FDA Resources
Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Primary Outcome Measures:
- Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an improvement ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
Secondary Outcome Measures:
- Ankylosing Spondylitis Quality of Life (ASQoL) Total Score Change From Baseline [ Time Frame: Baseline and 16 Weeks ] [ Designated as safety issue: Yes ]ASQoL is a questionnaire to assess disease specific quality of life. It consists of 18 statements that are relevant to the physical and mental conditions for a patient with Ankylosing Spondylitis (AS). Each statement is answered by the patients as a "Yes" (scored as 1) or "No" (scored as 0). All item scores are summed to give a total score. Scores can range from 0 (good QoL) to 18 (poor QoL).
| Enrollment: | 566 |
| 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 |
|---|---|
| Experimental: A |
Drug: etanercept
50 mg
|
| Active Comparator: B |
Drug: sulphasalazine (SSZ)
Sulphasalazine: The target dose for SSZ is 1.5 g (3 tablets) twice daily orally. Subject start the oral TA at 0.5 g daily for the first week and increase by 0.5 g every week until a daily dose of 3 g. 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 |
Criteria
Inclusion Criteria:
- Clinical diagnosis of ankylosing spondylitis
- Active ankylosing spondylitis
Exclusion Criteria:
- Complete ankylosis of spine
- Previous treatment with etanercept
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00247962
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Hide Study LocationsLocations
| Australia, Victoria | |
| Heidelberg West, Victoria, Australia, 3081 | |
| Australia, Western Australia | |
| Shenton Park, Western Australia, Australia, 6000 | |
| Austria | |
| Innsbruck, Austria, 6020 | |
| Klagenfurt, Austria, A-9020 | |
| Linz, Austria, A-4020 | |
| China | |
| Beijing, China, 100853 | |
| Shanghai, China, 200001 | |
| Czech Republic | |
| Ostrava, Czech Republic, 722 00 | |
| Praha, Czech Republic, 120 00 | |
| Denmark | |
| Frederiksberg, Denmark, DK-2000 | |
| Kolding, Denmark, 6000 | |
| Odense, Denmark, 5000 | |
| Vejle, Denmark, 7100 | |
| Finland | |
| Helsinki, Finland, 00029 | |
| Kuopio, Finland, 70211 | |
| Tampere, Finland, 33100 | |
| France | |
| Amiens, France, 80054 | |
| Bordeaux, France, 33076 | |
| Boulogne Billancourt, France, 92104 | |
| Creteil, France, 94010 | |
| Marseille, France, 13005 | |
| Nantes, France, 44000 | |
| Orleans, France, 45032 | |
| Pierre Mendès, France, 76290 | |
| Toulouse, France, 31059 | |
| Germany | |
| Berlin, Germany, 12200 | |
| Berlin, Germany, D-10117 | |
| Erlangen, Germany, D-91054 | |
| Gommern, Germany, D-39245 | |
| Hamburg, Germany, D-22081 | |
| Herne, Germany, D-44652 | |
| Heubnerweg, Germany, D-14059 | |
| Hildesheim, Germany, D-31134 | |
| Muenchen, Germany, D-80639 | |
| Pirna, Germany, D-01796 | |
| Ratingen, Germany, D-40882 | |
| Wiesbaden, Germany, 65185 | |
| Wiesbaden, Germany, D-65191 | |
| Hungary | |
| Debrecen, Hungary, 4043 | |
| Gyor, Hungary, 9025 | |
| Nyiregyhaza, Hungary, 4400 | |
| Pecs, Hungary, 7621 | |
| Szeged, Hungary, 6724 | |
| Ireland | |
| Wilton, Cork, Ireland | |
| Dublin, Ireland | |
| Italy | |
| Benevento, Italy, 82037 | |
| Bergamo, Italy, 24128 | |
| Firenze, Italy, 50143 | |
| Monserrato, Italy, 09042 | |
| Potenza, Italy, 85100 | |
| Prato, Italy, 59100 | |
| Reggio Emilia, Italy, 42100 | |
| Roma, Italy, 00161 | |
| Roma, Italy, 00189 | |
| Netherlands | |
| Amsterdam, Netherlands, 1081 HV | |
| Groningen, Netherlands, 9713GZ | |
| Leeuwarden, Netherlands, 8934AD | |
| Maastricht, Netherlands, 6229HX | |
| Nijmegen, Netherlands, 6522JV | |
| Poland | |
| Lodz, Poland, 93-513 | |
| Ustron Zawodzie, Poland, 43-450 | |
| Warszawa, Poland, 02-637 | |
| Wroclaw, Poland, 53-137 | |
| Qatar | |
| Doha, Qatar, 3050 | |
| Saudi Arabia | |
| Riyadh, Saudi Arabia, 11426 | |
| Spain | |
| Granollers, Barcelona, Spain, 08400 | |
| Asturias, Spain, 33012 | |
| Barcelona, Spain, 08003 | |
| Cordoba, Spain, 14004 | |
| Madrid, Spain, 28035 | |
| Madrid, Spain, 28922 | |
| Porto, Spain, 4200-319 | |
| Tenerife, Spain, 38010 | |
| Sweden | |
| Ostra kyrkogardsgatan, Sweden, 59333 | |
| Solna, Sweden, 17176 | |
| United Kingdom | |
| Upton, Wirral, United Kingdom, L49 5PE | |
| Basingstoke, United Kingdom, RG24 9NA | |
| Cambridge, United Kingdom, CB2 2QQ | |
| Cannock, United Kingdom, WS11 2XY | |
| Glasgow, United Kingdom, G31 2ER | |
| Liverpool, United Kingdom, L9 7AL | |
| Newcastle Upon Tyne, United Kingdom, NE7 7DN | |
| Upper Borough Walls, United Kingdom, BA1 1RL | |
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
| Study Director: | Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer |
| 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
No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Wyeth is now a wholly owned subsidiary of Pfizer |
| ClinicalTrials.gov Identifier: | NCT00247962 History of Changes |
| Other Study ID Numbers: | 0881A3-402 |
| Study First Received: | October 31, 2005 |
| Results First Received: | January 30, 2009 |
| Last Updated: | October 9, 2012 |
| Health Authority: | European Union: European Medicines Agency |
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
|
Ankylosing Spondylitis (AS) |
Additional relevant MeSH terms:
|
Spondylitis Spondylitis, Ankylosing Bone Diseases, Infectious Infection Bone Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthropathies Spondylarthritis Ankylosis Joint Diseases Arthritis Sulfasalazine TNFR-Fc fusion protein Anti-Inflammatory Agents, Non-Steroidal |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Anti-Infective Agents Gastrointestinal Agents Central Nervous System Agents Immunologic Factors Immunosuppressive Agents |
ClinicalTrials.gov processed this record on May 23, 2013