Skip to content

Can a short break from methotrexate improve the pneumonia vaccine response in people with Rheumatoid arthritis

A prospective, randomized, parallel-group trial on the effects of methotrexate continuation versus discontinuation for two weeks on pneumococcal conjugate vaccination in patients with rheumatoid arthritis. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/096664
Enrollment
120
Registered
2025-10-30
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Health Condition 1: M057- Rheumatoid arthritis with rheumatoid factor without organ or systems involvement

Interventions

Intervention1: Temporary discontinuation of Methotrexate (group B) post PCV 13 vaccination in Rheumatoid arthritis patient with stable disease.: The routine practice at study Centre is to administrate

Sponsors

Indian Rheumatology Association
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Eligible participants will be RA patients aged equal to or greater than 19 years, diagnosed by a consultant rheumatologist and satisfying 2010 American College of Rheumatology and EULAR classification criteria for rheumatoid arthritis. Only patients with stable disease receiving same MTX dose during preceding 6 weeks will be included. Patients on hydroxychloroquine or low-dose steroids, that is less than 5 mg prednisolone or equivalent are allowed.

Exclusion criteria

Exclusion criteria: 1.Exclusion criteria are patients taking combination DMARDs therapy, MTX with biological DMARDs, or MTX with targeted synthetic DMARDs use. 2.Patients with a history of anaphylaxis to any vaccine, those with fever at vaccination time, past history of demyelinating syndromes, pregnant or lactating women. 3.RA patients with overlap with other rheumatic diseases except secondary Sj gren s syndrome will also be excluded.

Design outcomes

Primary

MeasureTime frame
To compare the proportion of patients with a satisfactory vaccine response in both groupsTimepoint: 4 weeks 3 months 6 months

Secondary

MeasureTime frame
Secondary outcomes include analysis of factors affecting seroconversion status, recording adverse reactions and monitoring incidences of pneumonia or suspected invasive pneumococcal infections during the study period.Timepoint: 4 weeks 3 months 6 months

Countries

India

Contacts

Public ContactDr Sabarinath Mahadevan

Institute OF Rheumatology, RGGGH & Madras Medical College

msabari1987@gmail.com8072634837

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026