Rheumatology Biorepository

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-10

Study Completion Date

2100-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

2)Patient is starting an Eligible Medication\*with no prior exposure to the specific medication being prescribed.

3)Patient is able to complete Sample collection within fourteen (14) days prior to receiving thefirst dose of the Eligible Medication.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Corrona, LLC

Waltham, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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BIO-100

Identifier Type: -

Identifier Source: org_study_id