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This is a prospective open-label study to evaluated the efficacy and safety of infliximab(Remicade) in treating of patients with early ankylosing spondylitis (AS). Infliximab was injected intra-venous on baseline, 2nd week, 6th week, 12th week and 24th week, with dosing of 5mg/kg. The major outcome index is ASAS20, and minor outcome indexes include ASAS50 and ASAS70, BASDAI20,BASDAI50 and BASDAI70. And MRI of sacroiliac joint is not necessary. The adverse events at any time were recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| infliximab | Experimental | 200mg infliximab inject intra-venous on baseline, 2nd week, 6th week, 12th week, 24th week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| infliximab | Drug | 100mg/bottle 5mg/kg inject intra-venous on baseline, 2nd week, 6th week, 12th week, 24th week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achieving ASAS20 improvement. | 6th week |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achieving ASAS50 and ASAS70 | 6th week and 24 week. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Third Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510630 | China |
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| ID | Term |
|---|---|
| D013166 | Spondylitis |
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D001850 | Bone Diseases, Infectious |
| D007239 | Infections |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| D013122 |
| Spinal Diseases |
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |