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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: |
NCT00207701 |
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Date of registration:
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13/09/2005 |
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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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A Study of Infliximab (Remicade) in Patients With Ankylosing Spondylitis.
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Scientific title:
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A Randomized, Double-blind Trial of the Efficacy of REMICADE (Infliximab) Compared With Placebo in Subjects With Ankylosing Spondylitis Receiving Standard Anti-inflammatory Drug Therapy |
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Date of first enrolment:
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September 2002 |
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Target sample size:
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279 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00207701 |
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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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Centocor, Inc. Clinical Trial |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centocor, Inc. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Have had a diagnosis of definite Akylosing Spondylitis for at least 3 months prior to
screening
- Have active disease with spinal pain
- receiving or intolerant to standard anti-inflammatory agents
Exclusion Criteria:
- Have Rheumatoid Arthritis, systemic lupus erythematosus, or other inflammatory
rheumatic disease
- Have a documented history of fibromyalgia
- Have total ankylosis
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: infliximab
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Primary Outcome(s)
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The primary endpoint of this study was the proportion of subjects who achieved an ASAS 20 response at week 24.
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Secondary Outcome(s)
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The change from baseline in BASFI at week 24, the proportion of subjects who achieved an AS major clinical response at week 24, and the change from baseline in the physical component summary score of the SF-36 at week 24
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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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