Study Evaluating Etanercept and Sulphasalazine in Ankylosing Spondylitis
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00247962 |
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Recruitment Status :
Completed
First Posted : November 2, 2005
Results First Posted : November 8, 2012
Last Update Posted : November 8, 2012
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Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
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Brief Summary:
The purpose of this study is to compare the efficacy of etanercept and sulphasalazine in the treatment of Ankylosing Spondylitis.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ankylosing Spondylitis | Drug: etanercept Drug: sulphasalazine (SSZ) | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 566 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, 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 |
| Study Start Date : | December 2005 |
| Actual Primary Completion Date : | February 2008 |
| Actual Study Completion Date : | February 2008 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Ankylosing spondylitis
MedlinePlus related topics:
Ankylosing Spondylitis
| Arm | Intervention/treatment |
|---|---|
| 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. |
Primary Outcome Measures :
- Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20) [ Time Frame: 16 weeks ]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 ]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).
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00247962
Locations
Show 83 study locations
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 |
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 |
| Other Study ID Numbers: |
0881A3-402 |
| First Posted: | November 2, 2005 Key Record Dates |
| Results First Posted: | November 8, 2012 |
| Last Update Posted: | November 8, 2012 |
| Last Verified: | October 2012 |
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
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Ankylosing Spondylitis (AS) |
Additional relevant MeSH terms:
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Spondylitis Spondylarthritis Spondylitis, Ankylosing Bone Diseases, Infectious Infections Bone Diseases Musculoskeletal Diseases Spinal Diseases Arthritis Joint Diseases Axial Spondyloarthritis Spondylarthropathies Ankylosis Sulfasalazine |
Etanercept Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Gastrointestinal Agents Immunosuppressive Agents Immunologic Factors Anti-Infective Agents |