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

Primary Purpose

Juvenile Idiopathic Arthritis

Status
Unknown status
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Leflunomide
Sponsored by
Mashhad University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Juvenile Idiopathic Arthritis focused on measuring JIA, LEFLUNOMIDE, EFFICACY

Eligibility Criteria

2 Years - 19 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

leflunomide

placebo

Arm Description

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.

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.

Outcomes

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

Full Information

First Posted
December 10, 2013
Last Updated
December 25, 2013
Sponsor
Mashhad University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02024334
Brief Title
Efficacy Study of Leflunomide to Treat Juvenile Idiopathic Arthritis
Acronym
JIA
Official Title
Study of Therapeutic Effects and Side Effects of Leflunomide in Methotrexate Refractory Juvenile Idiopathic Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mashhad University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Idiopathic Arthritis
Keywords
JIA, LEFLUNOMIDE, EFFICACY

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
leflunomide
Arm Type
Active Comparator
Arm Description
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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Leflunomide
Other Intervention Name(s)
arava
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
baseline, week 4, week 8, week 12
Secondary Outcome Measure Information:
Title
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)
Description
6 variables including: number of joints with arthritis, number of joints with limited range of motion, physician assessment, patient assessment, ESR, CHAQ score.
Time Frame
baseline, week 4, week 8, week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zahra Rezaieyazdi, MD
Phone
009809153115860
Email
rezaieyazdiz@mums.ac.ir
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zahra Rezaieyazdi, MD
Organizational Affiliation
Rheumatic Diseases Research Center, Ghaem Hospital, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
Official's Role
Principal Investigator
Facility Information:
City
Mashhad
State/Province
Khorasan Razavi
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zahra Rezaeiyazdi, MD
Phone
00989153115860
First Name & Middle Initial & Last Name & Degree
malihe bokaiyan, MD

12. IPD Sharing Statement

Learn more about this trial

Efficacy Study of Leflunomide to Treat Juvenile Idiopathic Arthritis

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