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Interventional phase 3 study aiming to unravel the value of pulse steroids in achieving remission or low disease activity in refractory active JIA
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pulse steroid | Experimental | 108 patients will receive 125 mg solumedrol intravenous pulse for 2 consecutive days plus their concomitant medication. |
|
| without pulse | Placebo Comparator | 107 patients will not receive any additional medications. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solumedrol | Drug | 2 days pulse steroid injection 125 mg methylrednisolone |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al-Azhar University | Recruiting | Cairo | Egypt |
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| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D008776 | Methylprednisolone Hemisuccinate |
| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011278 |
| Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |