Health Condition 1: null- Rheumatoid Arthritis
Conditions
Interventions
Intervention1: Methotrexate 15 mg per week PO
to be increased every 15d by 2.5 mg per week (Max 25 mg) for 3 months: higher starting dose of methotrexate
Control Intervention1: Methotrexate 7.5 mg per
Sponsors
NIL
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with rheumatoid arthritis fulfilling the ACR 1987 criteria 2. Between 18 years to 65 year of age 3. Having active disease Disease activity score (28 joints) DAS28-3 more than 5.1 4. Not on methotrexate in the last 2 months 5. Permitted to be on corticosteroids if the dosages stable for at least 1 weeks before randomization and if corticosteroid dosage less than 10 mg/day 6. Permitted to be on other disease modifying anti-rheumatic drug (DMARD) like sulfasalazine, leflunomide and hydroxychloroquine, if dosages stable for at least 2 weeks before randomization
Exclusion criteria
Exclusion criteria: 1. Pregnant/Breastfeeding 2. Ongoing/Recent treatment with methotrexate (2 months) 3. Standard exclusion for MTX treatment a. Chronic liver disease b. Renal failure c. Any leucopenia or thrombocytopenia d. Breast-feeding e. Desirous of pregnancy in the next 6 months f. Known Hepatitis B or C positive g. Known clinically relevant chronic lung disease: ILD h. Tuberculosis or other active infections i. Known HIV positive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean fall in the DAS28-3 and proportion of patients with good response (final DAS28-3 less than 3.2 and fall more than 1.2) at 3 months.Timepoint: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients who withdrew because of any causeTimepoint: 3 months;Proportion requiring stoppage/decrease/inability to hike MTX due to cytopenia or transaminits (SGOT or SGPT more than 80IU)Timepoint: 3 months;Proportion who withdrew due to intoleranceTimepoint: 3 months | — |
Countries
India
Contacts
Public ContactDr Varun Dhir
Postgraduate institute of medical education and research (PGIMER)
Outcome results
None listed