Comparative Study of Leflunomide Plus Methotrexate Versus Methotrexate Monotherapy in Refractory Polyarticular Juvenile Idiopathic Arthritis Patients

Summary

A randomized control trial open level and parallel design was conducted in the department of paediatrics, Bangladesh Medical University (BMU). All diagnosed cases of Refractory Polyarticular JIA according to ILAR criteria, unresponsive to MTX were enrolled in this study. After getting written informed consent from the parents/legal guardians, a detailed structured data collection sheet was used for data collection. After enrollment all participants were allocated into experimental group and control group by randomization using random allocation software version 2.0. Total sample size of this study is 50 and 25 participants in each group. All patients of experimental group were given leflunomide along with existing MTX in refractory polyarticular JIA patients and injectable MTX were given at standard dose(15mg/m² BSA) Considering high disease activity steroid were continued in both group at low bridging dose 0.05-1 mg/kg/dose. Patient's disease activity status was assessed by JADAS-27 at initial visit, 6th weeks, 12 weeks and 24 weeks. Functional impairment was assessed by CHAQ-B (DI) at baseline and 24th weeks of treatment. Statistical analysis of the collected data were carried out by using an appropriate statistical tool.

Timeline

Start

2024-03-01

Primary completion

2025-12-31

Completion

2026-01-28

Publications

• Background Rezaieyazdi Z, Ravanshad S, Khodashahi M, Bokaeian M, Mehrad Majd H, Salari M. Comparison of the efficacy and safety of methotrexate alone or in combination with leflunomide in the treatment of juvenile idiopathic arthritis: a double-blind, placebo-controlled, randomized trial. Reumatologia. 2023;61(1):4-12. doi: 10.5114/reum/161317. Epub 2023 Mar 8.
• Background Ringold S, Angeles-Han ST, Beukelman T, Lovell D, Cuello CA, Becker ML, Colbert RA, Feldman BM, Ferguson PJ, Gewanter H, Guzman J, Horonjeff J, Nigrovic PA, Ombrello MJ, Passo MH, Stoll ML, Rabinovich CE, Schneider R, Halyabar O, Hays K, Shah AA, Sullivan N, Szymanski AM, Turgunbaev M, Turner A, Reston J. 2019 American College of Rheumatology/Arthritis Foundation Guideline for the Treatment of Juvenile Idiopathic Arthritis: Therapeutic Approaches for Non-Systemic Polyarthritis, Sacroiliitis, and Enthesitis. Arthritis Care Res (Hoboken). 2019 Jun;71(6):717-734. doi: 10.1002/acr.23870. Epub 2019 Apr 25.

Drugs

Indications