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This study was intended to assess the efficacy and safety of different Disease-Modifying Antirheumatic Drugs cycle combination regimen using the American College of Rheumatology (ACR) criteria of 20% improvement in symptoms (ACR20) in managing active adult rheumatoid arthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| leflunomide | Experimental | Leflunomide 10-20 mg/d |
|
| methotrexate | Active Comparator | MTX 7.5-15 mg/week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| leflunomide | Drug | Leflunomide 10-20 mg, orally, once daily for up to 48 weeks. Twelve weeks after the initial Leflunomide induction, patients were randomized into two groups (LEF+CTX:LEF+MTX=2:1) if the DAS 28 were higher than 2.6, or continuing leflunomide use without dosing change. Then, the disease activity was assessed using DAS 28 every 12 weeks. The regimen should remain unchanged if the DAS 28 reached to less than 2.6, otherwise, a third (24 weeks) or fourth (36 weeks) DMARs should be added. Intravenous CTX was administrated once 200-400mg per 3 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| ACR20 | Percentage of subjects who meet the response rate of ACR20 at each post-dose visit | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| ACR50 | Percentage of subjects who meet the response rate of ACR 50 at week 48 | 48 weeks |
| ACR70 | Percentage of subjects who meet the response rate of ACR 70 at week 48 |
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Inclusion Criteria:
RA patients:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li xiao feng | Contact | 086-0351-3074231 | lixiaofeng_sxey@163.com |
| Name | Affiliation | Role |
|---|---|---|
| li xiao feng | Second Hospital of Shanxi Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| rheumatism department,Second hospital of Shanxi medical university | Recruiting | Taiyuan | Shanxi | 030001 | China |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000077339 | Leflunomide |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| methotrexate | Drug | MTX 7.5-15 mg, orally, once weekly for up to 48 weeks. Twelve weeks after the initial MTX induction, patients were randomized into two groups (MTX+CTX:LEF+MTX=2:1) if the DAS 28 were higher than 2.6, or continuing MTX use without dosing change. Then, the disease activity was assessed using DAS 28 every 12 weeks. The regimen should remain unchanged if the DAS 28 reached to less than 2.6, otherwise, a third (24 weeks) or fourth (36 weeks) DMARs should be added. Intravenous CTX was administrated once |
|
| 48week |
| EULAR response:good response | Percentage of subjects who meet the EULAR response criteria of good response at week 48 | 48 week |
| EULAR response :moderate response | Percentage of subjects who meet the EULAR response criteria of moderate response at week 48 | 48 week |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000630 |
| Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |