Methotrexate in juvenile rheumatoid arthritis: randomized placebo controlled trial

Abstract

Objectives: To evaluate, whether short-term treatment with Methotrexate (MTX) at the dose of 10 mg/m² is superior to placebo in patients with Juvenile Rheumatoid arthritis (JRA) Patients and methods: In this double blind placebo controlled study, 31 patients who fulfilled the ACR criteria for the diagnosis of JRA were randomized to receive either weekly MTX 10mg/m² (n=16) or placebo (n=15) for 6 months. The patients were evaluated at baseline, 3 and 6 months. Measures of disease activity included, visual analog scale for pain, duration of early morning stiffness, number of swollen and tender joints, improvement in systemic features, global improvement by physician and parents, Hb and ESR. Thirty and 50% response were defined using the guideline set aside by WHO/ILAR for drug trial in patients with RA. Results: The two groups were well matched with respect to patients and disease variables at baseline. Six patients dropped out of the study. In the MTX group, 11(78%) out of 14 achieved 30% or more response as compared to 6/11 (54%) in the placebo group at 6 months. The corresponding figures at 3 months were 10/15 (66%) and 3/11 (27%) respectively in both the groups. The differences were statistically not significant. Furthermore, there was no statistical difference between the individual disease variable values at 3 or 6 months between the two groups. Conclusion: At the end of 6 months treatment, methotrexate at the dose of 10mg/m2 is not significantly superior to placebo in JRA.