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NCT07636057Not yet recruitingPhase 4

Comparison of Effectiveness and Safety of Tofacitinib Versus Upadacitinib as Add-on to Methotrexate in Rheumatoid Arthritis

Effectiveness and Safety of Tofacitinib Versus Upadacitinib as Add-on to Methotrexate in Rheumatoid Arthritis; Comparative Clinical Study

Source: ClinicalTrials.gov · Last updated 9 Jun 2026

Brief summary (registry, in English)

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

Status (registry)
Not yet recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
100 (estimated)
First submitted
29 Apr 2026
Start date
5 Jul 2026
Primary completion date
5 Mar 2027
Lead sponsor
Sheikh Zayed Federal Postgraduate Medical Institute
NCT number
NCT07636057

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 100
  • From 5 Jul 2026 to the primary completion date, 5 Mar 2027
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Lab values

  • • 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

Who the study is looking for

  • • Adult patients aged ≥18 years, regardless of gender

Age in the registry: 20 years to 55 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.