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

NCT07636057 | Not Yet Recruiting Phase 4

• 1 other identifier: TERC/SC/INT/2026/47
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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)

Outcome Measures

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.

  From enrollment in the study to 6 months of treatment

Secondary Outcomes (1)

• Frequency & severity of opportunistic infections

  From enrollment in the study to 6 months of treatment

Other Outcomes (1)

• Lipid profile

  From enrollment in the study to 6 months of treatment

Study Arms (2)

Tofacitinib

EXPERIMENTAL

5mg tofacitinib BD(oral) daily + 25mg Methotrexate oral once in a week

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

Upadacitinib

EXPERIMENTAL

15mg Upadacitinib OD(oral) daily + 25mg Methotrexate oral once in a week

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

Interventions

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.

Tofacitinib; Upadacitinib

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients aged ≥18 years, regardless of gender

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheikh Zayed Federal Postgraduate Medical Institute: lead

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

upadacitinib; Methotrexate

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Dr Sadia Maqsood Awan Assistant Professor Pharmacology FPGMI Lahore, MBBS, M.phil,MHPE

CONTACT

03335032495; sadia_maqsood_awan@yahoo.com

Dr Mudassra yaseen HOD pharmacology FPGMI, Lahore, MBBS, M.phil, CMT, PhD

CONTACT

03334162630; Drmudassarayaseen@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Sadia Maqsood Awan, Assistant professor

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: June 9, 2026
• Study Start (Estimated): July 5, 2026
• Primary Completion (Estimated): March 5, 2027
• Study Completion (Estimated): May 10, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-06