Table 1 RDCRN PRISM Protocols
Protocol | Consortium | Site Locations | Target Accrual | Study Type | Intervention Type | Age | Disease Status |
|---|---|---|---|---|---|---|---|
Abatacept (CTLA4-Ig) for the Treatment of Relapsing, Non-Severe, Granulomatosis with Polyangiitis (ABROGATE) | Vasculitis Clinical Research Consortium (VCRC) | US, Canada, UK, Ireland, Germany | 66 | Interventional RCT, Phase III | • Double-blinded • Placebo-controlled • Investigational agent | 15 years old and up | Mild flare- active disease at enrollment |
A Randomized, Multicenter Study for Isolated Skin Vasculitis (ARAMIS) | Vasculitis Clinical Research Consortium (VCRC) | US, Canada | 90 | Interventional sequential multiple assignment RCT | • 3 standard of care medications | 18 years old and up | Active disease at enrollment |
Longitudinal Evaluation of Autoimmune Pulmonary Alveolar Proteinosis (LongPAP) | Rare Lung Disease Consortium (RLDC) | US | 100 | Longitudinal, Observational | • None | All ages | Active Disease/ Remission (no major disease activity) |
Newer Direct-Acting Anti-Viral Agents as Sole Therapy of Porphyria Cutanea Tarda in Subjects with Chronic Hepatitis C | Porphyrias Consortium (PC) | US | 49 | Interventional | • Open label • One arm | 18 years old and up | PCT with chronic Hepatitis C |
A Randomized Double-Blind Controlled Trial of Everolimus in Individuals with PTEN Mutations | Developmental Synaptopathies Consortium (DSC) | US | 40 | Interventional, Phase I/II | • Placebo-controlled • Investigational agent | 5–45 years old | Outpatients with PTEN genetic mutation |
A Prospective, Multicenter Study to Compare and Validate Endoscopic, Histologic, Molecular, and Patient-Reported Outcomes in Pediatric and Adult Patients with Eosinophilic Esophagitis, Gastritis, and Colitis | Consortium of Eosinophilic Gastrointestinal Disease Researchers (CEGIR) | US | 1050 | Observational | • None | 3 years old and up | Active disease at enrollment |