Rheumatology Biorepository

NCT04899895 | Enrolling By Invitation

• 1 other identifier: BIO-100
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• 1. Biospecimen (blood) Collection

  Establish a collection of blood samples from patients with Rheumatoid Arthritis

  every 6 months for 10 years

• 2. Laboratory testing

  Testing for Biomarkers that describe disease activity or phenotypic disease subsets, risk prediction for certain types of adverse events

  every 6 months for 10 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• CorEvitas: lead

Study Sites (1)

Corrona, LLC

Waltham, Massachusetts, 02451, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 25, 2021
• Study Start: March 10, 2021
• Primary Completion (Estimated): December 1, 2100
• Study Completion (Estimated): December 1, 2100
• Last Updated: February 9, 2026

Record last verified: 2026-01

Locations

US (1)