Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2025-12-27 @ 10:13 PM
Study NCT ID:
NCT04899895
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-12-04
First Post:
2021-05-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rheumatology Biorepository
Sponsor:
CorEvitas
Organization:
Study Overview
Official Title:
Rheumatology Biorepository
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Biorepository is a prospective observational cohort study for patients under the care of a licensed physician or qualified physician extender. Target minimum enrollment is approximately 3,000 patients within the first 5 years of the study with no defined upper limit of enrollment. Sites from Corrona's current North America network will be asked to participate.
Participating sites and subjects will not receive results from any laboratory testing conducted on the Samples. Personal identifying information will not be collected along with the Samples.
Subjects will provide informed consent to contribute Samples to include blood (serum, plasma, whole blood) to the Biorepository. In the future, Subjects may be asked to contribute other samples (i.e. saliva, urine, stool) and an additional informed consent will be obtained. Subjects will retain the right to withdraw their consent for use of their Samples at any time. In such case, Corrona will destroy any unused/remaining Samples in its possession.
Participating sites and subjects will not receive results from any laboratory testing conducted on the Samples. Personal identifying information will not be collected along with the Samples.
Subjects will provide informed consent to contribute Samples to include blood (serum, plasma, whole blood) to the Biorepository. In the future, Subjects may be asked to contribute other samples (i.e. saliva, urine, stool) and an additional informed consent will be obtained. Subjects will retain the right to withdraw their consent for use of their Samples at any time. In such case, Corrona will destroy any unused/remaining Samples in its possession.
Detailed Description:
The purpose of the study is to develop a biorepository of biological samples ("Samples") from eligible patients enrolled in the Corrona Rheumatology Registries (each, a "Registry", together the "Registries"), including but not limited to registries related to rheumatoid arthritis (RA), psoriatic arthritis and spondyloarthritis (PsA/SpA), osteoarthritis, and lupus (the "Biorepository"). Collected Samples will be biobanked for immediate or future analysis.
The Biorepository will be used for various purposes, including to support identification and validation of biomarkers predictive of drug toxicities, safety outcomes (e.g. infections, malignancies, autoimmunity, venous thromboembolism), or response to specific therapies used for the diseases studied in the Registries. Other objectives may include research on biomarkers that describe disease activity or phenotypic disease subsets, and research to understand mechanism of disease or comorbidities.
A wide array of testing methods may be used, such as DNA and RNA sequencing, targeted analysis to analyze protein, lipid, metabolite, small molecule or biologic assays, and/or other studies. Analysis of Samples may include testing for existing and commercially available laboratory measures or experimental analysis. Samples will be selected for testing depending on factors such as: the disease under study, qualifying treatment and/or cohort, patient characteristics, risk factors or disease activity indicators, and research questions.
The Biorepository study will seek to support research in various rheumatologic disease states through Sample analyses.
The Biorepository will be used for various purposes, including to support identification and validation of biomarkers predictive of drug toxicities, safety outcomes (e.g. infections, malignancies, autoimmunity, venous thromboembolism), or response to specific therapies used for the diseases studied in the Registries. Other objectives may include research on biomarkers that describe disease activity or phenotypic disease subsets, and research to understand mechanism of disease or comorbidities.
A wide array of testing methods may be used, such as DNA and RNA sequencing, targeted analysis to analyze protein, lipid, metabolite, small molecule or biologic assays, and/or other studies. Analysis of Samples may include testing for existing and commercially available laboratory measures or experimental analysis. Samples will be selected for testing depending on factors such as: the disease under study, qualifying treatment and/or cohort, patient characteristics, risk factors or disease activity indicators, and research questions.
The Biorepository study will seek to support research in various rheumatologic disease states through Sample analyses.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: