Pulse Steroid Injection in Refractory Rheumatoid Arthritis

Phase 3

Recruiting

• Conditions: Active Rheumatoid Arthritis
• Interventions: Drug: Solumedrol

• Registration Number: NCT06456489
• Lead Sponsor: Sohag University

Brief Summary

Remission or low disease activity in active rheumatoid arthritis

Detailed Description

Assessment of rheumatoid arthritis activity by Disease activity score DAS28, DAS28 Erythrocyte sedimentation rate (ESR), American college of rheumatology (ACR) 20, ACR 50, ACR 70 will be done at baseline and every month for 3 consecutive months for both groups.

Study Timeline

• Study Start: 2024-05-01
• Status Verified: 2024-06
• Study First Submitted: 2024-06-01
• Study First Submitted QC: 2024-06-07
• Last Update Submitted: 2024-06-07
• Study First Posted: 2024-06-13
• Last Update Posted: 2024-06-13
• Primary Completion: 2024-09-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 268

Inclusion Criteria

• Refractory rheumatoid arthritis patients

Exclusion Criteria

• Other connective tissue diseases
• Endocrine diseases such as DM and thyroid disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pulse steroid solumedrol	Solumedrol	125 mg of methylprednisolone IV pulse will be administered for two consecutive days followed by oral steroid for 2 weeks with gradual withdrawal.
without pulse	Solumedrol	patients will not receive any additional treatment

Primary Outcome Measures

Name	Time	Method
remission or low disease activity	4 months	Outcome measurements for both groups will be done at baseline and every month for 3 months. DAS28, DAS28 ESR ACR20 ACR50 ACR70

Trial Locations

Locations (1)

Al-Azhar Univrsity; 🇪🇬 Cairo, Egypt