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Comparison of Tofacitinib, Methotrexate, and their Combination in the Treatment of Rheumatoid Arthritis: A Study on Effectiveness and Safety

A Comparative Study to Evaluate the Efficacy and Safety of Tofacitinib and Methotrexate as Monotherapy versus their Combination in the Management of Rheumatoid Arthritis - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/100720
Enrollment
90
Registered
2026-01-09
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M00-M99- Diseases of the musculoskeletal system and connective tissue

Interventions

Intervention1: Methotrexate: Tab. Methotrexate (Starting dose 5 mg/week) Intervention2: Tofacitinib: Tofacitinib 5mg/day BD Control Intervention1: NIL: NIL Control Intervention2: combination of Tofaci

Sponsors

Eras Lucknow Medical College Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age 18 or more than 18 years both males and females. Diagnosis of rheumatoid arthritis according to the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR)[A score of greater than or equal to 6/10 confirms the diagnosis of Rheumatoid Arthritis].

Exclusion criteria

Exclusion criteria: Any chronic systemic disease of liver, kidney, lungs and gastrointestinal tract. Other joint diseases (e.g. Osteoarthritis, Gout, Ankylosing Spondylitis) Severely immuno-compromised patient. Pregnant or breastfeeding women. Patient having contraindication for methotrexate(e.g. chronic liver disease, Bone marrow suppression, Active infections, Severe renal impairment).

Design outcomes

Primary

MeasureTime frame
Effectiveness of treatment evaluated by End Study Investigation and ACR20/ACR50/ACR70 response evaluation.Timepoint: 4 Wk 8 Wk 12 Wk 16 Wk 20 Wk and 24 weeks.

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactSingh Shashikumar Jitendra

Eras Lucknow Medical college and hospital

shakumsin9@gmail.com9555494381

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026