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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thalidomide 150mg | Active Comparator | Thalidomide 25mg/qd.po.2weeks; 50mg/qd.po.2weeks;100mg/qd.po.2weeks; 150mg/qd.po.to the end |
|
| Thalidomide 100mg | Active Comparator | Thalidomide 25mg/qd.po.2weeks; 50mg/qd.po.2weeks; 100mg/qd.po.to the end |
|
| Placebo | Placebo Comparator | Placebo po. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thalidomide 150mg | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20) | week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of ASDAS score | week 12 | |
| Change of ASDAS score | week 24 | |
| Mean change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical College | Bengbu | Anhui | 233004 | China | ||
| The General Hospital of People's Liberation Army |
Not provided
| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
Not provided
Not provided
| ID | Term |
|---|---|
| D013792 | Thalidomide |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
Not provided
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| Thalidomide 100mg |
| Drug |
|
|
| Placebo | Drug |
|
| week 24 |
| Mean change from baseline in Bath Ankylosing Spondylitis Function Index(BASFI) | week 24 |
| Mean change from baseline in Nocturnal Pain using a Visual Analog Scale(VAS) | week 24 |
| Mean change from baseline in back pain using a Visual Anolog Scale(VAS) | week 24 |
| Morning stiffness | week 24 |
| Number of Peripheral swollen joints | week 24 |
| Number of Peripheral joint tenderness | week 24 |
| Chest expansion | week 24 |
| ESR | week 24 |
| CRP | week 24 |
| Schober test | week 24 |
| Scoliosis | week 24 |
| Beijing |
| Beijing Municipality |
| 100853 |
| China |
| Zhongshan Hospital Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| Shanghai Guanghua Hospital | Shanghai | Shanghai Municipality | 200052 | China |
| Changhai Hospital | Shanghai | Shanghai Municipality | 200433 | China |
| Xijing Hospital | XiAn | Shanxi | 710032 | China |
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610041 | China |
| Sichuan Provincial People's Hospital | Chengdu | Sichuan | 610072 | China |
| The Xinjiang Uygur Autonomous Region people's Hospital | Ürümqi | Xinjiang | 830001 | China |
| D013122 |
| Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |