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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 October 2017 |
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Main ID: |
NCT01248793 |
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Date of registration:
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24/11/2010 |
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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 of the Safety and Efficacy of Golimumab in Chinese Patients With Ankylosing Spondylitis
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Scientific title:
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A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Golimumab in the Treatment of Chinese Subjects With Ankylosing Spondylitis |
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Date of first enrolment:
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October 2010 |
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Target sample size:
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213 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01248793 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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China
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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 a diagnosis of definite akylosing spondylitis for at least 3 months
- Have symptoms of active disease at screening and at baseline
- no active infections
Exclusion Criteria:
- Have other inflammatory diseases that might confound the evaluations of benefit from
the golimumab therapy
- Have complete ankylosis of the spine
- Have a history of latent or active granulomatous infection
- Have had a serious infection, or have been hospitalized for an infection, or have been
treated with intravenous (IV) antibiotics for an infection within 2 months prior to
first administration of study agent.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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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: Placebo
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Drug: Golimumab
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Drug: Golimumab (placebo group)
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Primary Outcome(s)
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Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 14
[Time Frame: Week 14]
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Secondary Outcome(s)
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Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 14
[Time Frame: Baseline and Week 14]
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Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 14
[Time Frame: Baseline and Week 14]
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Assessment of Ankylosing Spondylitis Response (ASAS 20) at Week 24
[Time Frame: Week 24]
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Secondary ID(s)
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CR015916
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C0524T29
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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