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It is a randomized controlled study
Randomization controlled study on Rheumatoid arthritis patients whos disease activity is high, controlled subjects will be given methotrexate and study subjects will get tofacitinib
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A | Experimental | group "A" is a control arm who will get conventional drug (methotrexate). 25 mg subcutaneous weekly . at 3 months if DAS-28 not fall by at least 1.2, drug is to be changed and regarded as therapy failure. if at least 1.2 improvement of DAS-28 occur,then therapy is continued for 6 monyhs |
|
| group B | Experimental | group "B" will get tofacitinib 10 mg weekly. if DAS-28 not improved at least 1.2 at 3 months, it is regarded as therapy failure. if improved at least 1.2, then therapy continued for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methotrexate | Drug | Methotrexate 25 mg subcutaneous is given in group A |
|
| Measure | Description | Time Frame |
|---|---|---|
| DAS-28 CRP at 6 month | disease activity score in 28 joints has to measured at 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| SDAI at 6 months | simplified disease activity index at 6 months | 6 months |
| HAQ-DI at 6 months | health assesment by HAQ-DI at 6 months |
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Inclusion Criteria:1. age greater than 18 years 2. patients fulfill the ACR-EULAR classification criteria for RA 3.DAS-28 CRP more than 5.1
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohammad M Khan, MBBS | Resident doctor, BSMMU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bangabandhu Seikh Mujib Medical University | Dhaka | Bangladesh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37377385 | Derived | Khan MM, Ahmed S, Hasan Sajib MK, Morshed AA, Mahbub-Uz-Zaman K, Haq SA. Tofacitinib versus methotrexate as the first-line disease-modifying antirheumatic drugs in the treatment of rheumatoid arthritis: An open-label randomized controlled trial. Int J Rheum Dis. 2023 Sep;26(9):1729-1736. doi: 10.1111/1756-185X.14801. Epub 2023 Jun 28. |
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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 |
|---|---|
| D008727 | Methotrexate |
| C479163 | tofacitinib |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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open label Randomization controlled clinical study
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| Tofacitinib | Drug | tofacitinib 10 mg given in group B |
|
|
| 6 months |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |