Efficacy Study of Leflunomide to Treat Juvenile Idiopathic Arthritis

Juvenile Idiopathic Arthritis Clinical Trial

— JIA  

Official title:

Study of Therapeutic Effects and Side Effects of Leflunomide in Methotrexate Refractory Juvenile Idiopathic Arthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02024334
• Other study ID #: 900527
• Status: Recruiting
• Phase: Phase 4
• First received: December 10, 2013
• Last updated: December 25, 2013
• Start date: June 2013
• Est. completion date: December 2014

Study information

• Verified date: December 2013
• Source: Mashhad University of Medical Sciences
• Contact: Zahra Rezaieyazdi, MD
• Phone: 009809153115860
• Email: rezaieyazdiz[@]mums.ac.ir
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

30 Patients(2-19 y) are randomly divided into two groups. In group 1 leflunomide will be added to conventional treatment, 5-20 mg daily based on weight.

In group 2 placebo will be prescribed as same as leflunomide. The course of treatment is 3 months. Every 4 weeks ACRped 30, 50, 70 should be determined to evaluate therapeutic response. Side effects of treatment will be assessed by physical examination and lab tests every 4 weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 19 Years

Eligibility

Inclusion Criteria:

• JIA based on ACR criteria

• age between 2- 19 y

• polyarticular, oligoarticular(> or = 3 active joints) or extended oligoarticular subtypes

• resistance to conventional treatment

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Juvenile Idiopathic Arthritis

Intervention

Drug:
• Leflunomide

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mashhad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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)	6 variables including: number of joints with arthritis, number of joints with limited range of motion, physician assessment, patient assessment, ESR, CHAQ score.	baseline, week 4, week 8, week 12	No