Systemic Lupus Erythematosus Clinical Trial
Official title:
The CARRA Registry
This CARRA Registry study will create a foundational database for rheumatic diseases of childhood using a novel informatics infrastructure developed as part of the larger clinical project. The creation of a CARRA-wide informatics infrastructure will enable efficient, observational, disease-related data capture across all CARRA sites for pediatric rheumatic diseases. The CARRA Registry study will demonstrate the feasibility of expanding to more data intensive registries for observational studies, comparative effectiveness research, pharmaceutical clinical trials and translational research.
This protocol represents one aim of a larger clinical project that will advance the
infrastructure of the Childhood Arthritis and Rheumatology Research Alliance (CARRA)
network, facilitate expanded clinical and translational pediatric research, and rapidly
transform the culture of pediatric rheumatology toward universal participation in research.
Through the creation of sophisticated informatics infrastructure, provision of comprehensive
site support and the engagement of families, patients, and communities, CARRA will provide
the opportunity for affected children at every CARRA site to participate in high quality
clinical and translational research.
The larger clinical project includes development of a CARRA-wide informatics platform with
capabilities for capture, storage, visualization, and secure HIPAA-compliant sharing of
validated disease metrics and relevant subject demographics, utilizing centralized
Electronic Data Capture (EDC) and phone interviews where appropriate, and ontology-based
data storage using a distributed database structure based on the NIH-supported i2b2
(Informatics Integrating Biology and the Bedside) framework. This will enable efficient,
observational, disease-related data capture across CARRA sites. The CARRA Registry described
in this protocol will form the foundational database and will involve the capture of data
including pediatric rheumatic diseases as described in Appendix A.
The CARRA Registry will support data collection from the use of consensus treatment plans
(CTPs), clinical trials, observational disease registries, comparative effectiveness
research, and other research on patients with pediatric rheumatic disease. The CARRA
Registry will form the basis for future CARRA studies and the Duke Clinical Research
Institute (DCRI) is serving as the CARRA Data Coordinating Center (DCC) for this protocol.
;
Observational Model: Cohort, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03843125 -
A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE)
|
Phase 3 | |
Recruiting |
NCT05698173 -
Systemic Lupus Erythematosus and Accelerated Aging
|
N/A | |
Active, not recruiting |
NCT01649765 -
Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy
|
Phase 2 | |
Recruiting |
NCT05704153 -
Modelling and Control of Non-invasive Vagus Nerve Stimulation for Autoimmune Diseases (1A)
|
N/A | |
Completed |
NCT05048238 -
Evaluation of Tofacitinib in Prevention of Photosensitivity in Lupus
|
Phase 1 | |
Recruiting |
NCT06056778 -
The Prevalence Evaluation of Systemic Lupus Erythematosus in Russian Patients With Reproductive Issues (PRISMA)
|
||
Completed |
NCT04358302 -
Individual Patient Exposure and Response in Pediatric Lupus
|
N/A | |
Completed |
NCT03802578 -
The Impact of Exercise on Hand Function, Daily Activities Performance and Quality of Life of SLE' Patients
|
N/A | |
Completed |
NCT02554019 -
Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus
|
Phase 2 | |
Recruiting |
NCT04835883 -
Exploring the Efficacy and Safety of CS20AT04 (Allogenic Bone Marrow-Derived Stem Cell) in Systemic Lupus Erythematosus Patients
|
Phase 2 | |
Terminated |
NCT02665364 -
Phase IIb Study of IFN-K in Systemic Lupus Erythematosus
|
Phase 2 | |
Completed |
NCT00278538 -
Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG)/Rituximab in Patients With Systemic Lupus Erythematosus
|
Phase 2 | |
Completed |
NCT00069342 -
Health Beliefs and Health Behaviors Among Minorities With Rheumatic Diseases
|
||
Completed |
NCT03252587 -
An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus
|
Phase 2 | |
Terminated |
NCT02066311 -
Nelfinavir in Systemic Lupus Erythematosus
|
Phase 2 | |
Recruiting |
NCT01892748 -
Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Systemic Lupus Erythematosus.
|
N/A | |
Terminated |
NCT01689025 -
An Investigation of Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus (SLE)
|
Phase 1 | |
Completed |
NCT01475149 -
Effect of HCQ on AnxA5 Resistance Assay in Antiphospholipid (aPL) Positive Patients With and Without Systemic Lupus Erythematosus (SLE)
|
N/A | |
Unknown status |
NCT01712529 -
Physical Exercise, Endothelial Function and Progenitor Endothelial Cells in Systemic Lupus Erythematosus Patients
|
N/A | |
Completed |
NCT00962832 -
A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus
|
Phase 2 |