NCT06463379

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
215

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2024

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 1, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 17, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

June 17, 2024

Status Verified

June 1, 2024

Enrollment Period

4 months

First QC Date

June 1, 2024

Last Update Submit

June 12, 2024

Conditions

Refractory Juvenile Idiopathic Arthritis (Despite 2 DMARDs Still Active)

Outcome Measures

Primary Outcomes (1)

  • remission or low disease activity

    patients will be assessed at baseline and every month for 3 months using Juvenile Arthritis Disease Activity Score (JADAS) for disease activity American College of Rheumatology Pediatric 30, 50, and 70 (ACR Pedi. 30, 50, 70) for disease activity

    3 months

Study Arms (2)

pulse steroid

EXPERIMENTAL

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

Drug: Solumedrol

without pulse

PLACEBO COMPARATOR

107 patients will not receive any additional medications.

Drug: Solumedrol

Interventions

SolumedrolDRUG

2 days pulse steroid injection 125 mg methylrednisolone

pulse steroidwithout pulse

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients still active despite administration o 2 DMARDs

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

Methylprednisolone Hemisuccinate

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

MethylprednisolonePrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 1, 2024

First Posted

June 17, 2024

Study Start

May 1, 2024

Primary Completion

August 31, 2024

Study Completion

August 31, 2024

Last Updated

June 17, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)