Revealing the Potential of Intravenous Pulse Steroid Therapy; Impressive Results in Attaining Remission or Low Disease Activity in Refractory Rheumatoid Arthritis
| Registry | NCT06456489 |
|---|---|
| Status | Unknown |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 268 (Estimated) |
| Sponsor | Sohag University (Other) |
| Conditions | Active Rheumatoid Arthritis |
| Interventions | Solumedrol (Drug) |
| Dates | start 2024-05-01, primary completion 2024-09-30 (estimated), completion 2024-12-31 (estimated), first posted 2024-06-13, last updated 2024-06-13 |
| Locations | 1 site in Egypt |
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All trials for Active Rheumatoid Arthritis All trials of Solumedrol
Remission or low disease activity in active rheumatoid arthritis
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| pulse steroid solumedrol | Experimental | Drug: 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 | Placebo comparator | Drug: Solumedrol | patients will not receive any additional treatment |
Sex: All, ages: 20 Years to 65 Years
Inclusion Criteria: * Refractory rheumatoid arthritis patients Exclusion Criteria: * Other connective tissue diseases * Endocrine diseases such as DM and thyroid disorders
| Facility | City | Country | Status |
|---|---|---|---|
| Al-Azhar Univrsity | Cairo | Egypt | Recruiting |