Health Condition 1: M069- Rheumatoid arthritis, unspecified
Conditions
Interventions
Intervention1: Leucovorin: Oral Leucovorin 15 mg will be given 12 hours after last dose of Methotrexate, once a week for 6 weeks
Control Intervention1: Placebo: Oral Placebo will be given 12 hours aft
Sponsors
Post Graduate Institute of Medical Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: The study recruits individuals aged 18 - 60 years, diagnosed with rheumatoid arthritis as per ACR/EULAR 2010 rheumatoid arthritis classification criteria, who are taking Methotrexate at any dose and any form for at least 3 months and have developed severe Methotrexate intolerance (with a Methotrexate intolerance and severity assessment in adults score (MISA) of 6 or more) for at least 1 month.
Exclusion criteria
Exclusion criteria: Exclusion criteria include those who are already taking leucovorin, those who have abnormal liver function tests, cytopenias in one or more cell lines, methotrexate induced mucositis and skin rashes/ulcers, and those who are not willing to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the change in MISA score (Methotrexate Intolerance Severity and Assessment in Adults) with and without leucovorin.Timepoint: At 6 weeks and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Disease Activity Score (DAS 28) from baseline, with and without Leucovorin.Timepoint: At 6 weeks and 12 weeks;To assess treatment adherence using pill count, with and without leucovorin.Timepoint: At 6 weeks and 12 weeks;To assess for patient preference using 5 point Likert scale, on leucovorin versus placebo.Timepoint: At 6 weeks and 12 weeks | — |
Countries
India
Contacts
Public ContactNuzhah V
Post Graduate Institute of Medical Education And Research
Outcome results
None listed