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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: |
NCT00421915 |
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Date of registration:
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08/01/2007 |
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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 Evaluating Etanercept Treatment of Patients With Ankylosing Spondylitis
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Scientific title:
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Multicenter, Double-Blind, Parallel, Placebo-Controlled, Randomised Phase 3 Study of Etanercept in the Treatment of Patients With Ankylosing Spondylitis: 12-Week Final Data |
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Date of first enrolment:
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March 2002 |
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Target sample size:
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84 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00421915 |
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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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Main inclusion criteria
- Diagnosis of AS (defined by Modified New York Criteria for Ankylosing Spondylitis).
- Active AS (defined by the average of scores on the visual analog scale [VAS] of = 30
for duration and intensity of morning stiffness and by 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).
- 18 to 70 years of age.
Main exclusion criteria
- Complete ankylosis (fusion) of spine.
- Previous receipt of etanercept, antibody to tumour necrosis factor alpha (TNFa), or
other TNFa inhibitors.
- Use of disease-modifying antirheumatic drugs (DMARDs) other than hydroxychloroquine,
sulphasalazine, or methotrexate within 4 weeks of baseline.
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: Enbrel (etanercept)
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Primary Outcome(s)
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To compare the efficacy of etanercept (25 mg, twice weekly) with that of placebo based on the
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percentage of patients who achieved the assessment in Ankylosing Spondylitis (ASAS 20%) response criteria at week 12.
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Secondary Outcome(s)
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compared with that of placebo using the ASAS response criteria at 50% and 70% levels at week 12.
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To assess: 1) the safety of etanercept in this patient population; 2) the efficacy of etanercept
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Secondary ID(s)
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0881A3-311
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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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