Comparison of Effectiveness and Safety of Tofacitinib Versus Upadacitinib as Add-on to Methotrexate in Rheumatoid Arthritis
NCT07636057 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2026-06-09
Summary
The goal of this interventional study is to learn, whether Tofacitinib or upadacitinib is more effective in treating the patients of Rheumatoid Arthritis. It will also learn about the safety of these two agents. The main questions it aims to answer are:
* Which JAK inhibitor (Tofacitinib or Upadacitinib) is more effective to improve the disease activity of Rheumatoid arthritis in Pakistani population?
* What is the Disease Activity scores, ESR, CRP, RA factor level of patients?
* What are the side effects of both drugs, during the study time?
Participants:
* Of Group A will be taking 5mg Tofacitinib oral daily for 6 months along with 25mg of once weekly dose of oral Methotrexate, whereas of Group B will be taking 15mg Upadacitinib oral daily for 6 months along with 25mg of once weekly dose of oral methotrexate.
* Will Visit the clinic once at 3 months and then 6 months for checkups and tests
* Will Keep a diary of any infection, treatment taken, duration of infection
* Will inform the researcher about any unusual side effect during the study
Conditions
- Rheumatoid Arthritis (RA)
Interventions
- DRUG
-
JAK inhibitor(tofacitinib/upadacitinib) as advised by the rheumatologist as add on to 25 mg methotrexate
There is no comparative study of tofacitinib with upadacitinib in Pakistan, as upadacitinib is recently been available here. There is no study yet in pakistan to compare the effectiveness and safety of these two JAK inhibitors in Pakistani population.
Sponsors & Collaborators
-
Sheikh Zayed Federal Postgraduate Medical Institute
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-05
- Primary Completion
- 2027-03-05
- Completion
- 2027-05-10
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