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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00458185 |
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Date of registration:
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05/04/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study Evaluating Etanercept in Patients With Ankylosing Spondylitis
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Scientific title:
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Multicentre, Open-Labeled Study Of Etanercept In The Treatment Of Patients With Ankylosing Spondylitis |
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Date of first enrolment:
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August 2006 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00458185 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Contacts
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wyeth is now a wholly owned subsidiary of Pfizer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis,
aged between 18 and 70 years of age.
- BASDAI greater than or equal to 40 (all scores on a scale of 0 to 100).
- Negative result of serum human chorionic gonadotropin (HCG) pregnancy test taken at
screening in all women except those surgically sterile or at least 1 year
postmenopausal.
Exclusion Criteria:
- Complete ankylosis (fusion) of spine.
- Previous receipt of etanercept, antibody to TNFa, or other TNFa inhibitors.
- Use of disease modifying antirheumatic drugs (DMARDs) other than hydroxychloroquine,
sulphasalazine, and methotrexate within 4 weeks of baseline. Patients treated with
hydroxychloroquine, sulphasalazine, and methotrexate may continue these drugs during
this study but doses must be held stable for 4 weeks before baseline examination and
for the duration of the study.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ankylosing Spondylitis
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Intervention(s)
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Drug: etanercept
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Primary Outcome(s)
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To determine the efficacy of etanercept (25 mg, twice weekly) based on the percentage of patients who achieve the Assessment in Ankylosing Spondylitis (ASAS) Response Criteria at 20% level at week 12.
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Secondary Outcome(s)
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Efficacy at 50% and 70% levels week 12; frequency and time to partial remission; safety; patient and physician global assessment, nocturnal and total back pain, BASFI, BASDAI; spinal mobility; complete joint assessment; hip involvement; ESR, CRP.
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Secondary ID(s)
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0881A-101871
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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