Pulse Steroid Injection in Refractory Rheumatoid Arthritis

Sohag University

Status and phase: Enrolling; Phase 3

Conditions: Active Rheumatoid Arthritis

Treatments: Drug: Solumedrol

Study type: Interventional

Funder types: Other

Identifiers

NCT06456489

Al-Azhar University

Details and patient eligibility

About

Remission or low disease activity in active rheumatoid arthritis

Full 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.

Enrollment: 268 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Refractory rheumatoid arthritis patients

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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268 participants in 2 patient groups, including a placebo group

pulse steroid solumedrol

Experimental group

Description:

125 mg of methylprednisolone IV pulse will be administered for two consecutive days followed by oral steroid for 2 weeks with gradual withdrawal.

Treatment:

Drug: Solumedrol

without pulse

Placebo Comparator group

Description:

patients will not receive any additional treatment

Treatment:

Drug: Solumedrol