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

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ClinicalTrials.gov Identifier: NCT02024334
Recruitment Status : Unknown
Verified December 2013 by Zahra Rezaieyazdi, Mashhad University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : December 31, 2013
Last Update Posted : December 31, 2013
Sponsor:
Information provided by (Responsible Party):
Zahra Rezaieyazdi, Mashhad University of Medical Sciences

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 2013
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Leflunomide

Arms and Interventions
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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 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.


Outcome Measures
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Primary Outcome Measures :
  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) [ Time Frame: 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 :
  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) [ Time Frame: 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
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Ages Eligible for Study:   2 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02024334


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

Locations
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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
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Principal Investigator: Zahra Rezaieyazdi, MD Rheumatic Diseases Research Center, Ghaem Hospital, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
More Information
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Responsible Party: Zahra Rezaieyazdi, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02024334     History of Changes
Other Study ID Numbers: 900527
First Posted: December 31, 2013    Key Record Dates
Last Update Posted: December 31, 2013
Last Verified: December 2013

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

Additional relevant MeSH terms:
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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
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs