Total Glucosides Paeony Capsules in Maintaining Clinical Remission in Patients With Ankylosing Spondylitis Which Achieve Clinical Remission After Anti-TNF Therapy
NCT ID: NCT01517620
Last Updated: 2013-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
38 participants
INTERVENTIONAL
2011-11-30
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Total Glucosides Paeony, Capsules
Total Glucosides Paeony Capsules
Total Glucosides Paeony Capsules, oral, 0.3 gram per capsule, 3 capsules tid, 24 weeks
no intervention
No interventions assigned to this group
Interventions
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Total Glucosides Paeony Capsules
Total Glucosides Paeony Capsules, oral, 0.3 gram per capsule, 3 capsules tid, 24 weeks
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
16 Years
65 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Gu Jieruo
Department of Rheumatology, Third Affiliated Hospital of Sun Yat-sen University
Locations
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Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, , China
Countries
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Other Identifiers
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[2011]2-38
Identifier Type: -
Identifier Source: org_study_id