Status:
COMPLETED
Total Glucosides Paeony Capsules in Maintaining Clinical Remission in Patients With Ankylosing Spondylitis Which Achieve Clinical Remission After Anti-TNF Therapy
Lead Sponsor:
Sun Yat-sen University
Conditions:
Ankylosing Spondylitis
Eligibility:
All Genders
16-65 years
Phase:
PHASE4
Brief Summary
This is a prospective, randomized, open-label clinical trial to evaluate the efficacy and safety of total glucosides paeony capsules in maintaining clinical remission in patients with ankylosing spond...
Eligibility Criteria
Inclusion
- Aged from 16-65 years, sign the Informed Consent
- Fulfill 1984 modified NewYork classification criteria for AS
- Achieved clinical remission after at least 12 weeks' therapy of anti-TNF therapy
- Hb≥9g/dl, ALT/AST≤ 2 folds of upper level normal range, creatine≤120mol/L(≤1.4mg/dl)
- Commitment to contraceptive for woman
Exclusion
- History of psoriasis and/or inflammatory bowel diseases
- Receive intra-articular injection of cortisone within 3 months before enrollment
- History of the listed diseases: heart failure, Multiple sclerosis, severe chronic obstructive pulmonary disease, frequent infections, lymphoma or other cancers, tuberculosis
- Pregnant and lactating women
- Mentally ill, Alcoholics and drug addicts
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01517620
Start Date
November 1 2011
End Date
November 1 2012
Last Update
December 13 2013
Active Locations (2)
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1
Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630
2
Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, China