Efficacy Study of Leflunomide to Treat Juvenile Idiopathic Arthritis

NCT02024334 | Unknown Phase 4 DMC

• 1 other identifier: 900527
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized double blind clinical trial to assess efficacy of leflunomide in treatment of refractory juvenile idiopathic arthritis. Patients are randomly divided into two groups. In group 1 leflunomide and in group 2 placebos will be added to conventional treatment for three months. therapeutic responses will be evaluated by ACRpedi (American College of Rheumatology Pediatric) scores every 4 weeks.

Conditions

Juvenile Idiopathic Arthritis

Keywords

JIA; LEFLUNOMIDE; EFFICACY

Outcome Measures

Primary Outcomes (1)

• thirty percent changes in the ACR Pediatric core set of disease activity measures in at least three of the six response variables (ACR Pedi 30)

  6 variables including: number of joints with arthritis, number of joints with limited range of motion, physician assessment, patient assessment, ESR (Erythrocyte Sedimentation Rate), CHAQ (Childhood Health Assessment Questionnaire) score.

  baseline, week 4, week 8, week 12

Secondary Outcomes (1)

• 50% and 70% changes in the ACR Pediatric core set of disease activity measures in at least three of the six response variables (ACR Pedi 30)

  baseline, week 4, week 8, week 12

Study Arms (2)

leflunomide

ACTIVE COMPARATOR

leflunomide tablet: for patients less than 20 kg: 10 mg every 2 day, for patients 20 - 40 kg: 10 mg daily, for patients more than 40 kg: 20 mg daily.

Drug: Leflunomide

placebo

PLACEBO COMPARATOR

placebo tablet for patients less than 20 kg: 10 mg every 2 day, for patients 20 - 40 kg: 10 mg daily, for patients more than 40 kg: 20 mg daily.

Interventions

Leflunomide DRUG

Also known as: arava

leflunomide

Eligibility Criteria

• Age: 2 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• JIA based on ACR criteria
• age between 2- 19 y
• polyarticular, oligoarticular(\> or = 3 active joints) or extended oligoarticular subtypes
• resistance to conventional treatment

You may not qualify if:

• pregnancy
• malignancy
• severe active infection
• other rheumatic diseases or overlap
• ALT(Alanine transaminase) or bilirubin \> 3 folds
• IVIG (Intravenous immunoglobulin) treatment during last 2 weeks
• biologic agents during last 3 months

Sponsors & Collaborators

• Mashhad University of Medical Sciences: lead

Study Sites (1)

Unknown Facility

Mashhad, Khorasan Razavi, Iran

RECRUITING

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

Leflunomide

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Zahra Rezaieyazdi, MD

  Rheumatic Diseases Research Center, Ghaem Hospital, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zahra Rezaieyazdi, MD

CONTACT

009809153115860; rezaieyazdiz@mums.ac.ir

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mashhad University of Medical Sciences

Study Record Dates

• First Submitted: December 10, 2013
• First Posted: December 31, 2013
• Study Start: June 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 31, 2013

Record last verified: 2013-12

Locations

IR (1)