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A Phase 1, Multicenter, Open-Label Study Of CC-97540 (BMS-986353), CD19-Targeted Nex-T Chimeric Antigen Receptor (CAR) T Cells, In Participants With Severe, Refractory Autoimmune Diseases: Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathy Or Systemic Sclerosis (Breakfree-1)
Rochester, Minn.,
Jacksonville, Fla.
The purpose of this study is to establish the tolerability, preliminary efficacy, and pharmacokinetics of CC-97540 in participants with severe, refractory autoimmune diseases (Breakfree-1).
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A Phase 1/2, Open-label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T Cells (CABA-201) in Subjects With Active Systemic Lupus Erythematosus
Jacksonville, Fla.
The purpose of this study is to evaluate the safety and tolerability of CABA-201 in subjects with active Systemic Lupus Erythematosus.
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A Real-World Comparative Effectiveness Trial of Treatment Strategies in Patients With Rheumatoid Arthritis: The RA-PRO Pragmatic Trial (RA-PROPR) (RA-PROPR)
Jacksonville, Fla.
The objectives of this study are to compare improvements in PROs with RA treatment strategies to each other using a state-of-the-art real-world pragmatic effectiveness study design, which will for the first time include most RA patients with comorbidities;(2) compare their toxicity in a real-world population for TNFi-biologic vs. tsDMARD. To our knowledge, no previous RCT comparing these drugs has examined a PRO as a primary outcome in RA, which our study will pioneer by using HAQ. HAQ is sensitive to change with effective treatments.
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