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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age20-55
SponsorSheikh Zayed Federal Postgraduate Medical Institute

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

• Adult patients aged ≥18 years, regardless of gender

Disqualifiers

• 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

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Drug

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: TofacitinibExperimental treatment 1 intervention
Group B: UpadacitinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in the Disease activity score(DAS 28)

Change in Disease Activity Score-28 ranges from 0 to 10, with ≤2.6 indicates remission, 2.6-3.2 low disease activity, ≥ 3.2-5.1 moderate activity, ≥ 5.1 high disease activity.

Time frame
From enrollment in the study to 6 months of treatment

Secondary outcomes

1

Frequency & severity of opportunistic infections

Severity of opportunistic infections according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, which classifies adverse events from Grade 1 (mild) to Grade 5 (death)21. * Grade 1 (Mild): Asymptomatic or mild infection; no or minimal intervention required * Grade 2 (Moderate): Symptomatic infection requiring medical treatment (e.g., oral antibiotics/antivirals); no hospitalization * Grade 3 (Severe): Severe infection requiring hospitalization or intravenous therapy * Grade 4 (Life-threatening): Life-threatening infection requiring urgent intervention/ICU care * Grade 5: Death related to infection

Time frame
From enrollment in the study to 6 months of treatment

Other outcomes

1

Lipid profile

Change in Lipid Profile; Total cholesterol \>200 mg/dL , LDL \>130 mg/dL ,HDL \<40 mg/dL, Triglycerides \>150 mg/dL

Time frame
From enrollment in the study to 6 months of treatment

Locations

This trial has no locations.

Sponsors and contacts

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