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This is a randomized, double-blind, multicentral clinical trial to investigate the efficacy and safety of Fengshigutong Capsule in the treatment of active ankylosing spondylitis(AS). The primary purpose is to assess the different maintaining treatment programme in AS patients with controlled inflammation by Imrecoxib. The trial will include 180 patients who will be divided into three group: Fengshigutong Capsule plus Imrecoxib group, Imrecoxib group and Fengshigutong Capsule group. Patients will complete the 4-week therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fengshigutong Capsule plus Imrecoxib | Experimental | Fengshigutong Capsule 1.2g twice a day,Imrecoxib 0.1g twice a day,orally |
|
| Fengshigutong Capsule | Experimental | Fengshigutong Capsule 1.2g twice a day,orally |
|
| Imrecoxib | Active Comparator | Imrecoxib 0.1g twice a day,orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fengshigutong Capsule plus Imrecoxib | Drug | Fengshigutong Capsule 1.2g twice a day,Imrecoxib 0.1g twice a day,orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| the proportions of patients reaching Assessment in Ankylosing Spondylitis 20% | ASAS20 was defined as an improvement of ≥20% and absolute improvement of ≥1 unit (0-10-cm VAS) from baseline in ≥3 of the following 4 domains (and absence of deterioration in any domain): patient's global assessment of disease activity (PTGA), pain assessment (mean of total and nocturnal pain scores), Bath Ankylosing Spondylitis Functional Index (BASFI), and clinical inflammation (mean of 2 morning stiffness-related scores on the BASDAI) | 4 week |
| Measure | Description | Time Frame |
|---|---|---|
| the proportions of patients reaching Assessment in Ankylosing Spondylitis 50% | defined as 20% improvement in 5 of the following 6 domains: PTGA, pain assessment, BASFI, clinical inflammation, spinal mobility, and C-reactive protein (CRP) | 4 week |
| ASAS20 response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jieruo Gu, Prof | Contact | +8620-85252055 | gujieruo@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jieruo Gu, Prof | Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rheumatology Department, the Third Affiliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | China |
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| Fengshigutong Capsule | Drug | Fengshigutong Capsule 1.2g twice a day,orally |
|
| Imrecoxib | Drug | Imrecoxib 0.1g twice a day,orally |
|
ASAS20 was defined as an improvement of ≥20% and absolute improvement of ≥1 unit (0-10-cm VAS) from baseline in ≥3 of the following 4 domains (and absence of deterioration in any domain): patient's global assessment of disease activity (PTGA), pain assessment (mean of total and nocturnal pain scores), Bath Ankylosing Spondylitis Functional Index (BASFI), and clinical inflammation (mean of 2 morning stiffness-related scores on the BASDAI) |
| 4 week |
| ASAS5/6 response | defined as 20% improvement in 5 of the following 6 domains: PTGA, pain assessment, BASFI, clinical inflammation, spinal mobility, and C-reactive protein (CRP) | 4 week |
| 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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| ID | Term |
|---|---|
| C488833 | Imrecoxib |
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