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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 spondylitis which achieved clinical remission after anti-TNF therapy. Patients will be divided into two groups randomly, one group receive non-steroid anti-inflammatory drugs(NSAID) mono-therapy and the other group receive total glucosides paeony capsules plus NSAID therapy for 24 weeks. The primary clinical endpoint is the proportion of patients which disease activity reaches relapse criteria. The investigator's hypothesis the proportion of relapse in total glucosides paeony capsules plus NSAID group would be lower than the NSAID mono-therapy group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total Glucosides Paeony, Capsules | Experimental |
| |
| no intervention | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Glucosides Paeony Capsules | Drug | Total Glucosides Paeony Capsules, oral, 0.3 gram per capsule, 3 capsules tid, 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| the proportion of patients which disease activity reaches relapse criteria | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| BASDAI score comparing to baseline | 24 weeks | |
| BASFI score comparing to baseline | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510630 | China | ||
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| Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University |
| Guangzhou |
| China |
| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
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