The Efficacy of Intravenous Pulse in Attaining Remission in Refractory Juvenile Idiopathic Arthritis

Sohag University

Status and phase: Enrolling; Phase 3

Conditions: Refractory Juvenile Idiopathic Arthritis (Despite 2 DMARDs Still Active)

Treatments: Drug: Solumedrol

Study type: Interventional

Funder types: Other

Identifiers

NCT06463379

00000049

Details and patient eligibility

About

Interventional phase 3 study aiming to unravel the value of pulse steroids in achieving remission or low disease activity in refractory active JIA

Full description

First group will receive 2 consecutive days intravenous pulse of 125 mg methylprednisolone.

Second group will not receive additional drugs. Assessment was done at baseline and every month for 3 months for both groups using Juvenile Arthritis Disease Activity Score (JADAS) and the American College of Rheumatology Pediatric 30, 50, and 70 response criteria (ACR Pedi. 30, 50, 70).

Enrollment: 215 estimated patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients still active despite administration o 2 DMARDs

Exclusion criteria

• Other connective tissue diseases
• Endocrine disorders such as Thyroid disorders.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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215 participants in 2 patient groups, including a placebo group

pulse steroid

Experimental group

Description:

108 patients will receive 125 mg solumedrol intravenous pulse for 2 consecutive days plus their concomitant medication.

Treatment:

Drug: Solumedrol

without pulse

Placebo Comparator group

Description:

107 patients will not receive any additional medications.

Treatment:

Drug: Solumedrol