A study to compare the effectiveness and safety of tofacitinib alone versus tofacitinib in combination with methotrexate in patients with rheumatoid arthritis

Efficacy, Safety and Tolerability of Tofacitinib in addition to Methotrexate versus Tofacitinib as a Monotherapy in Patients with Rheumatoid Arthritis - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/102260

Enrollment

Registered

2026-01-28

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: M059- Rheumatoid arthritis with rheumatoid factor, unspecified

Interventions

Intervention1: Tofacitinib: Tofacitinib 5mg BD for 6 months Control Intervention1: Tofacitinib + Methotrexate: Tofacitinib + Methotrexate

Eligibility

Inclusion criteria

Inclusion criteria: Age between 18-50years diagnosed With Rheumatoid Arthritis on methotrexate from last one month

Exclusion criteria

Exclusion criteria: 1.Pregnant women and lactating women, those who deny to take contraceptives during study period. 2. Patients who deny to provide Consent form.

Design outcomes

Primary

Measure	Time frame
Comparing the DAS28 response of both groups at 24 weeks when compared to baselineTimepoint: 24 weeks	—

Secondary

Measure	Time frame
Occurrence of adverse events and serious adverse events (including Change from baseline in clinical laboratory test, Physical Examination and vital sign recorded as adverse events)Timepoint: 24weeks	—

Countries

India

Contacts

Public ContactShushank Mahajan

Chitkara College of Pharmacy

Sanjana@chitkara.edu.in09736236229

Outcome results

None listed

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