Rituximab versus leflunomide in methotrexate non responders rheumatoid arthritis patients

Comparison of rituximab versus leflunomide in combination with methotrexate in patients with active rheumatoid arthritis despite methotrexate treatment- an open label randomised controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/07/035221

Enrollment

Registered

2021-07-28

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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: Rituximab: Injection Rituximab 1000mg, 2 doses, given 14 days apart. Control Intervention1: Leflunomide: Tablet Leflunomide 10-20mg once daily per oral for 6 months

Eligibility

Inclusion criteria

Inclusion criteria: Patients with active rheumatoid arthritis despite treatment with 10-25 mg/week of Methotrexate for at least 3 months

Exclusion criteria

Exclusion criteria: a. Patients who have been treated with Leflunomide or Rituximab previously b. ACR functional class IV c. Presence of an overlapping disease d. History of recurrent infections in the past e. Pregnant or lactating women

Design outcomes

Primary

Measure	Time frame
ACR20 responseTimepoint: 24 weeks	—

Secondary

Measure	Time frame
ACR50 responseTimepoint: 24 weeks;ACR70 responseTimepoint: 24 weeks	—

Countries

India

Contacts

Public ContactRashmi Roongta

Institute of Postgraduate Medical Education and Research

geet4in@yahoo.co.in9433514259

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026