Efficacy Study of Leflunomide to Treat Juvenile Idiopathic Arthritis (JIA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Mashhad University of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Zahra Rezaieyazdi, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT02024334
First received: December 10, 2013
Last updated: December 25, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Juvenile Idiopathic Arthritis
Drug: Leflunomide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Study of Therapeutic Effects and Side Effects of Leflunomide in Methotrexate Refractory Juvenile Idiopathic Arthritis

Resource links provided by NLM:


Further study details as provided by Mashhad University of Medical Sciences:

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) [ Time Frame: baseline, week 4, week 8, week 12 ] [ Designated as safety issue: No ]
    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) [ Time Frame: baseline, week 4, week 8, week 12 ] [ Designated as safety issue: No ]
    6 variables including: number of joints with arthritis, number of joints with limited range of motion, physician assessment, patient assessment, ESR, CHAQ score.


Estimated Enrollment: 30
Study Start Date: June 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

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.

  Eligibility

Ages Eligible for Study:   2 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02024334

Contacts
Contact: Zahra Rezaieyazdi, MD 009809153115860 rezaieyazdiz@mums.ac.ir

Locations
Iran, Islamic Republic of
Recruiting
Mashhad, Khorasan Razavi, Iran, Islamic Republic of
Contact: Zahra Rezaeiyazdi, MD    00989153115860      
Sub-Investigator: malihe bokaiyan, MD         
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
  More Information

No publications provided

Responsible Party: Zahra Rezaieyazdi, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02024334     History of Changes
Other Study ID Numbers: 900527
Study First Received: December 10, 2013
Last Updated: December 25, 2013
Health Authority: Iran: Ethics Committee

Keywords provided by Mashhad University of Medical Sciences:
JIA
LEFLUNOMIDE
EFFICACY

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Leflunomide
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 11, 2014