Efficacy of Tofacitinib, Methotrexate Combination Therapy Versus Upadacitinib, Methotrexate Combination Therapy in Moderate to Severe Rheumatoid Arthritis

Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Study ID: NCT07008846
Phase: PHASE3
Status: Active Not Recruiting

Conditions

Moderate to Severe Rheumatoid Arthritis

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

To see the efficacy of Upadacitinib, Methotrexate versus Tofacitinib, Methotrexate in moderate to severe Rheumatoid arthritis — DRUG
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

Study Details

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

Key Dates

Start date: May 10, 2025
Status verified: May 2025
Primary completion: Sep 30, 2026
Completion: Sep 30, 2026

Study Design

Enrollment: 96 participants (estimated)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Arms

Experimental: Efficacy of upadacitinib, methotrexate combination therapy versus tofacitinib, methotrexate combinat

Primary Outcome Measure

DAS28-CRP [ 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" ]