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The drug regimes in treating ankylosing spondylitis(AS) have limitations. The tumor necrosis factor inhibitors(TNFi) was effective but expensive. Disease modifying anti-rheumatic drugs (DMARDs) were cheap but insufficient. This study proposed a sequential usage of TNFi, the Yisaipu®, and DMARDs, and aims to evaluate the mid-term therapeutic effect of this new scheme in treating the mild-to-moderate AS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Yisaipu® was introduced only during the active state and was switched to DMARDs, methotrexate(MTX), sulfasalazine(SSZ) and hydroxychloroquine(HCQ), after disease remission (ESR & CRP reduce to normal and BASDAI<4) maintenance. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yisaipu® | Drug | Yisaipu® was introduced only during the active state and was switched to DMARDs, methotrexate(MTX), sulfasalazine(SSZ) and hydroxychloroquine(HCQ), after disease remission (ESR & CRP reduce to normal and BASDAI<4) maintenance. |
| Measure | Description | Time Frame |
|---|---|---|
| ASAS 20 | Improvement of >20% and >1 unit in at least 3 domains on a scale of 10;No worsening of >20% and >1 unit in remaining domain on a scale of 10 compare to the baseline status | 3 months after |
| ASAS 20 | Improvement of >20% and >1 unit in at least 3 domains on a scale of 10;No worsening of >20% and >1 unit in remaining domain on a scale of 10 compare to the baseline status | 6 months after |
| ASAS 20 | Improvement of >20% and >1 unit in at least 3 domains on a scale of 10;No worsening of >20% and >1 unit in remaining domain on a scale of 10 compare to the baseline status | 12 months after |
| ASAS 40 | Improvement of >40% and >2 unit in at least 3 domains on a scale of 10;No worsening at all in remaining domain compare to the baseline status | 3 months after |
| ASAS 40 | Improvement of >40% and >2 unit in at least 3 domains on a scale of 10;No worsening at all in remaining domain compare to the baseline status | 6 months after |
| ASAS 40 | Improvement of >40% and >2 unit in at least 3 domains on a scale of 10;No worsening at all in remaining domain compare to the baseline status | 12 months after |
| Measure | Description | Time Frame |
|---|---|---|
| BASDAI | Bath Ankylosing Spondylitis Disease Activity Index | baseline,3 months after,6 months after,12 months after |
| BASFI | BASDAI Bath Ankylosing Spondylitis Functional Index |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital | Guangzhou | Guangdong | 510515 | China |
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| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| D012460 | Sulfasalazine |
| D006886 | Hydroxychloroquine |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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Yisaipu® was introduced only during the active state and was switched to DMARDs, methotrexate(MTX), sulfasalazine(SSZ) and hydroxychloroquine(HCQ), after disease remission (ESR & CRP reduce to normal and BASDAI<4) maintenance.
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| baseline,3 months after,6 months after,12 months after |
| Patient Global Assessment | Measuring disease activity by using the visual analogue scales (VAS) on which patients rated the severity of their symptoms from 0 (none) to 10 (most severe) . | baseline,3 months after,6 months after,12 months after |
| CRP | acute-phase reactant(C-reactive protein) | baseline,3 months after,6 months after,12 months after |
| ESR | acute-phase reactant(Erythrocyte Sedimentation rate ) | baseline,3 months after,6 months after,12 months after |
| SQOL-AS | SQOL-AS(The Scale of Quality of Life for Ankylosing Spondylitis) questionnaire consists of physiological function, psychological state, social adaptation and self-awareness 4 dimensions. There are 5 to 8 questions in every dimension. The score ranges are 8 to 40 for physiological function, 6 to 30 for psychological state, 5 to 25 for social adaptation and 6 to 30 for self-awareness. The more score that patients got means the better state they were in that dimension, namely, the batter quality of life. | baseline,3 months after,6 months after,12 months after |
| D013122 |
| Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |