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

NCT07636057

Not Yet RecruitingPhase 4

Sponsor: Sheikh Zayed Federal Postgraduate Medical Institute

Conditions: Rheumatoid Arthritis (RA)

Interventions: JAK inhibitor(tofacitinib/upadacitinib) as advised by the rheumatologist as add on to 25 mg methotrexate

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

Eligibility overview

Sex: ALL

Age: 20 Years to 55 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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