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

Mashhad University of Medical Sciences

Status and phase: Unknown; Phase 4

Conditions: Juvenile Idiopathic Arthritis

Treatments: Drug: Leflunomide

Study type: Interventional

Funder types: Other

Identifiers

NCT02024334

900527

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 2 to 19 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

30 participants in 2 patient groups, including a placebo group

leflunomide

Active Comparator group

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.

Treatment:

Drug: Leflunomide

placebo

Placebo Comparator group

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.