JIA: Efficacy Study of Leflunomide to Treat Juvenile Idiopathic Arthritis

Sponsor

Mashhad University of Medical Sciences (Other)

Overall Status

Unknown status

CT.gov ID

NCT02024334

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Juvenile Idiopathic Arthritis	Drug: Leflunomide	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2013

Anticipated Primary Completion Date :

Jun 1, 2014

Anticipated Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: leflunomide 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 Other Names: arava
Placebo Comparator: placebo 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.

Arm

Intervention/Treatment

Active Comparator: leflunomide

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

Other Names:

arava

Placebo Comparator: placebo

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.

Outcome Measures

Primary Outcome Measures

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) [baseline, week 4, week 8, week 12]
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.

Secondary Outcome Measures

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]
6 variables including: number of joints with arthritis, number of joints with limited range of motion, physician assessment, patient assessment, ESR, CHAQ score.

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 19 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Mashhad	Khorasan Razavi	Iran, Islamic Republic of

Sponsors and Collaborators

Mashhad University of Medical Sciences

Investigators

Principal Investigator: Zahra Rezaieyazdi, MD, Rheumatic Diseases Research Center, Ghaem Hospital, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran