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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: |
NCT00418548 |
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Date of registration:
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04/01/2007 |
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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 Comparing Etanercept 50 mg Once Weekly to 25 mg Twice Weekly in Patients With Ankylosing Spondylitis
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Scientific title:
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A Randomized, Double-Blind, Placebo Controlled Trial Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly Compared With 25 mg Twice Weekly in Subjects With Ankylosing Spondylitis |
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Date of first enrolment:
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June 2004 |
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Target sample size:
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350 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00418548 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 3
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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.
- Active AS, defined by average of visual analog scale (VAS) of = 30 for duration and
intensity of morning stiffness and at least 2 of the following: VAS for patient
global assessment = 30; average of VAS for nocturnal and total pain = 30; BASFI = 30
(all scores on a scale of 0 to 100).
Exclusion Criteria:
- Complete ankylosis (fusion) of spine.
- Previous treatment with etanercept, antibody to Tumor Necrosis Factor a (TNFa), or
other TNFa inhibitors or other biologic agents.
- Use of disease modifying antirheumatic drugs (DMARDs) other than hydroxychloroquine,
sulphasalazine, and methotrexate within 4 weeks of baseline. Subjects 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.
- Receipt of multiple nonsteroidal anti-inflammatory drugs (NSAIDs) at baseline.
- Dose of NSAID changed within 2 weeks of baseline evaluation.
- Dose of prednisone >10 mg/day (or equivalent) or changed within 2 weeks of baseline
evaluation.
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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The primary objective is to assess the efficacy (measured by % of subjects achieving ASAS 20 (Assessments in Ankylosing Spondylitis 20%) at week 12) and safety of etanercept 50 mg once weekly.
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Secondary ID(s)
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0881A3-314
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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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