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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: |
NCT00889694 |
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Date of registration:
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27/04/2009 |
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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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Clinical Study of Tripterygium Capsule to Treat Early Ankylosing Spondylitis
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Scientific title:
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Clinical Study of Tripterygium Capsule to Treat Early Ankylosing Spondylitis: a 12-Week, Multiple Centers, Randomized Double-Blind, Positive Drug and Placebo Controlled Clinical Trial |
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Date of first enrolment:
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October 2008 |
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Target sample size:
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80 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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http://clinicaltrials.gov/show/NCT00889694 |
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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 (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Fulfill the ESSG criteria for SpA and not fulfill any criteria for the subtype
including ankylosing spondylitis, psoriatic arthritis, reactive arthritis and
inflammatory bowel disease associated arthritis.
2. Disease is in active status defined by BASDAI>=40mm.
3. DMARDs administration must be suspended for at least 4 weeks before screening. NSAIDs
dose must be stable for at least 4 weeks before screening.
Exclusion Criteria:
1. Intra-articular injection of glucocorticoid within 3 months.
2. Previous history of heart failure, multiple sclerosis, chronic obstructive pulmonary
disease, recurrent infection, lymphoma or other tumors.
3. Accompanied by fibromyalgia syndrome or other rheumatic diseases.
4. Female of pregnancy or breast-feeding.
5. Poor compliance or with mental diseases.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Early Ankylosing Spondylitis
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Intervention(s)
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Drug: Sulfasalazine
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Drug: Tripterygium
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Drug: placebo
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Primary Outcome(s)
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ASAS20
[Time Frame: 12th week]
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Secondary Outcome(s)
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BASDAI20/50/70
[Time Frame: 12th week]
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Secondary ID(s)
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[2008]2-4
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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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