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Efficacy Study of Leflunomide to Treat Juvenile Idiopathic Arthritis

NCT ID: NCT02024334

Last Updated: 2013-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Juvenile Idiopathic Arthritis

Keywords

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JIA LEFLUNOMIDE EFFICACY

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Leflunomide

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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Leflunomide

Intervention Type DRUG

Other Intervention Names

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arava

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mashhad University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Zahra Rezaieyazdi

Mashhad University of Medical Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zahra Rezaieyazdi, MD

Role: PRINCIPAL_INVESTIGATOR

Rheumatic Diseases Research Center, Ghaem Hospital, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran

Locations

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Mashhad, Khorasan Razavi, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Zahra Rezaieyazdi, MD

Role: CONTACT

Phone: 009809153115860

Email: [email protected]

Facility Contacts

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Zahra Rezaeiyazdi, MD

Role: primary

Other Identifiers

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900527

Identifier Type: -

Identifier Source: org_study_id