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

NCT07428551 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-02-23

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Leflunomide plus Methotrexate

In experimental group, all patients were given leflunomide along with existing methotrexate. Leflunomide was prescribed as once daily oral dose before meal on weight based 10mg for patients 10 to \<20kg, 15mg for patients 20-40kg and 20mg for patients \>40kg. Every medication were purchased from a single pharmaceutical company. Along with leflunomide, all the study participants of this group were received existing MTX subcutaneously at a dose of 15 mg/m2/ week in a single weekly dose. Considering high disease activity level, steroids were continued at low bridging dose at 0.5-1mg/kg/day and then it was stopped by gradually tapering in both group. Nonsteroidal anti-inflammatory drugs were continued as necessary

DRUG

Methotrexate Monotherapy

Participants of control group were given existing MTX subcutaneously at a dose of 15 mg/m²/ week in a single weekly dose at night. Considering high disease activity level, steroids were continued at low bridging dose at 0.5-1mg/kg/day and then it was stopped by gradually tapering in both group. Nonsteroidal anti-inflammatory drugs were continued as necessary.

Sponsors & Collaborators

  • Bangladesh Medical University

    lead OTHER

Principal Investigators

  • Md. Mahbubur Rahman · Phase B Resident

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2025-12-31
Completion
2026-01-28

Countries

  • Bangladesh

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07428551 on ClinicalTrials.gov