Rheumatology Biorepository

• ClinicalTrials.gov Identifier: NCT04899895
• Recruitment Status: Enrolling by invitation
• First Posted: May 25, 2021
• Last Update Posted: November 10, 2022
• Sponsor: CorEvitas
• Information provided by (Responsible Party): CorEvitas

Tracking Information

• First Submitted Date: May 3, 2021
• First Posted Date: May 25, 2021
• Last Update Posted Date: November 10, 2022
• Actual Study Start Date: March 10, 2021
• Estimated Primary Completion Date: December 2100 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 19, 2021)

• 1. Biospecimen (blood) Collection [ Time Frame: every 6 months for 10 years ]
  Establish a collection of blood samples from patients with Rheumatoid Arthritis
• 2. Laboratory testing [ Time Frame: every 6 months for 10 years ]
  Testing for Biomarkers that describe disease activity or phenotypic disease subsets, risk prediction for certain types of adverse events

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Rheumatology Biorepository
• Official Title: Rheumatology Biorepository

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.

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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: The following eligibility criteria are designed to select patients for whom study assessments are deemed appropriate. Patients must have attained at least the locally recognized age of consent and provide written or electronic informed consent to participate
• Condition: Rheumatoid Arthritis
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: May 19, 2021): 3000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2100
• Estimated Primary Completion Date: December 2100 (Final data collection date for primary outcome measure)

Eligibility Criteria

A patient must satisfy all of the following criteria to be eligible for enrollment in the Biorepository study .1)Patient is currently participating in a Registry or is eligible to participate and enrolls in a Registry prior to enrollment in the Biorepository study.

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04899895
• Other Study ID Numbers: BIO-100
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: CorEvitas
• Original Responsible Party: Same as current
• Current Study Sponsor: CorEvitas
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: CorEvitas
• Verification Date: November 2022