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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: |
NCT00434044 |
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Date of registration:
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09/02/2007 |
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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 the Treatment of Subjects With Ankylosing Spondylitis
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Scientific title:
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Multicenter, Double-Blind, Placebo-Controlled, Randomized Phase III Study of Etanercept in the Treatment of Subjects With Ankylosing Spondylitis |
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Date of first enrolment:
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February 2007 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00434044 |
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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:
1. Must be of Chinese ancestry and living in China.
2. Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis.
3. Active AS at time of enrollment, defined by average of visual analog scale (VAS)
values for duration and intensity of morning stiffness 30 and two of the following:
VAS for patient global assessment 30; average of VAS for nocturnal and total pain 30;
BASFI greater than or equal to 30 (all scores on a scale of 0 to 100).
Exclusion Criteria:
1. Complete ankylosis (fusion) of spine.
2. Previous treatment with etanercept, antibody to Tumor Necrosis Factor a (TNFa), or
other TNFa inhibitors or other biologic agents.
3. 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.
Age minimum:
18 Years
Age maximum:
N/A
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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Assessment in Ankylosing Spondylitis (ASAS) response criteria 20% at week six.
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Secondary Outcome(s)
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ASAS 20% response at all visits except week two. ASAS 50%, 70%, 40%, 5/6 responses at all visits.
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Secondary ID(s)
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0881A3-322
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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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