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

NCT ID: NCT06463379

Last Updated: 2024-06-17

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

215 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2024-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Refractory Juvenile Idiopathic Arthritis (Despite 2 DMARDs Still Active)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

pulse steroid

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

Group Type EXPERIMENTAL

Solumedrol

Intervention Type DRUG

2 days pulse steroid injection 125 mg methylrednisolone

without pulse

107 patients will not receive any additional medications.

Group Type PLACEBO_COMPARATOR

Solumedrol

Intervention Type DRUG

2 days pulse steroid injection 125 mg methylrednisolone

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Solumedrol

2 days pulse steroid injection 125 mg methylrednisolone

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients still active despite administration o 2 DMARDs

Exclusion Criteria

* Other connective tissue diseases
* Endocrine disorders such as Thyroid disorders.
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sohag University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ahmed Mahrous

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Al-Azhar University

Cairo, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Hany m. EITTA

Role: primary

01007796825

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

00000049

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.