Status:
UNKNOWN
Clinical Study of Tripterygium Capsule to Treat Early Ankylosing Spondylitis
Lead Sponsor:
Sun Yat-sen University
Conditions:
Early Ankylosing Spondylitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
This study is a 12-week, randomized, placebo and positive drug controlled clinical trial to investigate whether tripterygium capsule is effective and safe in treating patients with ankylosing spondyli...
Eligibility Criteria
Inclusion
- 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.
- Disease is in active status defined by BASDAI\>=40mm.
- 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
- Intra-articular injection of glucocorticoid within 3 months.
- Previous history of heart failure, multiple sclerosis, chronic obstructive pulmonary disease, recurrent infection, lymphoma or other tumors.
- Accompanied by fibromyalgia syndrome or other rheumatic diseases.
- Female of pregnancy or breast-feeding.
- Poor compliance or with mental diseases.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2009
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00889694
Start Date
October 1 2008
End Date
August 1 2009
Last Update
April 29 2009
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