A Phase 3 interventional study of To see the efficacy of Upadacitinib, Methotrexate versus Tofacitinib, Methotrexate in moderate to severe Rheumatoid arthritis in Moderate to Severe Rheumatoid Arthritis, sponsored by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh. Active, not recruiting at 1 site in Bangladesh. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-06.
Sponsored by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh · Phase 3, Interventional, and Health services research
The aim of this study is to assess the efficacy of upadacitinib, methotrexate combination therapy in comparison to tofacitinib, methotrexate combination therapy in moderate to severe RA patients. This study will guide us to treat RA patients with inadequate response to methotrexate more effectively
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's planned enrollment of 96 is close to the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh is the lead sponsor of 126 studies on the registry; 24 are open to participants now.
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3.Patients with DAS-28 CRP >3.2 despite optimum dose and duration of methotrexate (20-25 mg/week for minimum one month).
Exclusion Criteria:
1.Recent or concurrent infection
2.Active or latent tuberculosis
Drug: To see the efficacy of Upadacitinib, Methotrexate versus Tofacitinib, Methotrexate in moderate to severe Rheumatoid arthritis
This intervention is open label. Both patient and investigator will know about the intervention. Participants are allocated according to block randomization. Total two groups with each contain 48 patients. One group will be given Tofacitinib, Methotrexate and another group will be given Upadacitinib, Methotrexate
DAS28-CRP
Number of Participants with Low disease activity or Remission as Assessed by DAS28-CRP, Change from Baseline in Pain Scores on the Visual Analog Scale at 24Weeks).
Time frame: Outcome 1:"Disease Activity Score 28 CRP (DAS28-CRP) at week 4" Outcome 2:"Disease Activity Score 28 CRP (DAS28-CRP) at week 12" Outcome 3:"Disease Activity Score 28 CRP (DAS28-CRP) at week 24"
Plan to share: Undecided
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This study is active, not recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh