Clinical Trial: Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]
Official Title: Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry
Brief Summary: Continuation of the CARRA Registry as described in the protocol will support data collection on patients with pediatric-onset rheumatic diseases. The CARRA Registry will form the basis for future CARRA studies. In particular, this observational registry will be used to answer pressing questions about therapeutics used to treat pediatric rheumatic diseases, including safety questions.
Detailed Summary:
The original Childhood Arthritis & Rheumatology Research Alliance (CARRA) Registry (Protocol Number: CRNT_REGST01) was first established in 2010 to advance alliance infrastructure, facilitate expanded clinical and translational pediatric research, and transform the culture of pediatric rheumatology toward universal participation in research. This original CARRA Registry will be referred to throughout the protocol as the CARRA Legacy Registry. Through the creation of a sophisticated informatics infrastructure, provision of comprehensive site support and the engagement of families, patients, and communities, the CARRA Registry will provide the opportunity for affected children at every CARRA Registry site to participate in high-quality clinical and translational research.
Continuation of the CARRA Registry as described in this protocol will support data collection on patients with pediatric-onset rheumatic diseases. The CARRA Registry will form the basis for future CARRA studies. In particular, this observational registry will be used to answer pressing questions about therapeutics used to treat pediatric rheumatic diseases, including examining safety questions. The Duke Clinical Research Institute (DCRI) is serving as the CARRA Clinical and Data Coordinating Center (CDCC) for the protocol.
Traditional exposure-based post-marketing registries of individual therapeutic agents for juvenile idiopathic arthritis (JIA), systemic lupus erythematosus, and other rheumatic diseases are inadequate for answering important safety questions for many reasons:
- Sample sizes are too small to detect uncommon but important events
- No unexposed comparators exist to evaluate risk attributable to underlying disease Sponsor: Duke University
- Prospectively collect essential data elements from children, adolescents and young adults with pediatric rheumatic diseases [ Time Frame: Approximately 10 years ]
- Evaluate the safety of therapeutic agents in persons with pediatric onset rheumatic diseases [ Time Frame: Approximately 10 years ]
- Evaluate clinical outcomes associated with the use of therapeutic agents in persons with pediatric onset rheumatic diseases [ Time Frame: Approximately 10 years ]
- Document drug treatment patterns and clinical course of persons with pediatric onset rheumatic diseases over time. [ Time Frame: Approximately 10 years ]
- Evaluate factors other than drug treatments that are associated with clinical outcomes in pediatric onset rheumatic diseases [ Time Frame: Approximately 10 years ]
Current Primary Outcome:
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome: Same as current
Information By: Duke University
Dates:
Date Received: April 13, 2015
Date Started: July 2015
Date Completion: December 2028
Last Updated: September 2, 2016
Last Verified: July 2016
