Comparison of Effectiveness and Safety of Tofacitinib Versus Upadacitinib as Add-on to Methotrexa… (NCT07636057) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Comparison of Effectiveness and Safety of Tofacitinib Versus Upadacitinib as Add-on to Methotrexate in Rheumatoid Arthritis
100 participantsStarted 2026-07-05
Plain-language 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
Who can participate
Age range
20 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* • Adult patients aged ≥18 years, regardless of gender
Exclusion Criteria:
* • Other autoimmune rheumatic disorders (SLE, psoriatic arthritis, AS, etc.)
* Administration of any biologic DMARD in the previous three months
* History of a serious infection (e.g., active tuberculosis or sepsis)
* Previous or existing history of recurrent infections or immunosuppressive status
* History of any malignancy in the last five years.
* Current chemotherapy, radiotherapy or intake of any genotoxic drug
* Severe liver impairment (e.g., ALT/AST \>3× ULN)
* Severe renal impairment (e.g., estimated GFR \<30 mL/min)
* Severe Haematological Abnormalities: Hb \<8 g/dL, TLC \<3,000 /mm³, Platelets \<100,000 /mm³
* Past or present deep vein thrombosis or pulmonary embolism
* Pregnant or lactating women
* Women of reproductive age who are not practicing adequate contraception measures
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compares tofacitinib and upadacitinib added on top of methotrexate — since I'm already on or considering methotrexate, is my current treatment situation a good fit for how this study is designed?
2Because this trial hasn't started recruiting yet, how long might I realistically have to wait before I could even enroll, and does that waiting period affect my treatment plan right now?
3Both tofacitinib and upadacitinib are JAK inhibitors that have known safety considerations like infection risk and cardiovascular concerns — how do those risks apply specifically to my health history, and is that something we should weigh carefully before I consider joining?
4This is a Phase 4 trial, which means both drugs are already approved — does that change how much is already known about their safety compared to earlier-phase studies, and what new information is this trial actually trying to find out?
5Since the trial measures disease activity using the DAS28 score, would you be tracking that score with me already as part of my standard care, and how would participating in this study change the way my progress is monitored?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the Disease activity score(DAS 28)
Timeframe: From enrollment in the study to 6 months of treatment
Trial details
NCT IDNCT07636057
SponsorSheikh Zayed Federal Postgraduate Medical Institute
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2027-03-05
Contact for this trial
Dr Sadia Maqsood Awan Assistant Professor Pharmacology FPGMI Lahore, MBBS, M.phil,MHPE