Status:
ENROLLING_BY_INVITATION
CorEvitas Rheumatoid Arthritis (RA) Drug Safety & Effectiveness Registry
Lead Sponsor:
CorEvitas
Collaborating Sponsors:
University of Massachusetts, Worcester
University of Alabama at Birmingham
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Brief Summary
This prospective, non-interventional research registry is designed to study the comparative effectiveness and comparative safety of approved treatments for RA in a cohort of patients cared for by rheu...
Detailed Description
The primary objective for this registry is to systematically collect and document use patterns, effectiveness, and safety of DMARDs (Disease Modifying Anti-Rheumatic Drugs), biologic agents, and any o...
Eligibility Criteria
Inclusion
- Be at least 18 years of age or older.
- Be able and willing to provide written consent for participation in the registry as well as Personally Identifiable Information (PII) that includes Full Name and Date of Birth at a minimum.
- Have been diagnosed with rheumatoid arthritis by a rheumatologist.
- Meet at least one of the following criteria:
- (A) Currently receiving an Eligible Medication\*\* that was started within 365 days of the Enrollment Visit.
- i. A temporary interruption of an Eligible Medication is allowed if the interruption in treatment lasted \<180 days.
- (B) Prescribed or receiving the first dose of an Eligible Medication\*\* on the day of the Enrollment Visit.
- (C) Diagnosed with RA within 365 days of the Enrollment Visit regardless of treatment regimen ("Early RA").
Exclusion
- The patient must not:
- Have a diagnosis of Juvenile idiopathic arthritis (JIA), Psoriatic arthritis (PsA), Spondyloarthritis (SpA), Ankylosing spondylitis (AS), Systemic lupus erythematosus (SLE), or any other form of autoimmune inflammatory arthritis.
- Be starting only a non-eligible medication, unless the patient was diagnosed with RA within 365 days of the Enrollment Visit. Non-eligible medications include conventional DMARDs - for example methotrexate, sulfasalazine, leflunomide, etc. - and including prednisone.
- Be participating in or planning to participate in a double-blind randomized clinical trial of an RA drug. Of note, concurrent participation in another observational registry or open-label Phase 3b/4 trial is not excluded.
- Early Follow-Up Visit Criteria
- To be eligible for an early CorEvitas Follow-Up Visit that is conducted \<150 days since the last registry visit, the following conditions must be met:
- A follow-up set of questionnaires should always be completed whenever a registry subject is being prescribed or receiving the first dose of a new (different) Eligible Medication\*\* at a routine office visit. If this occurs less than 150 days from the previous visit at which CorEvitas questionnaires had been completed, it is considered an "Early Follow-Up Visit." The next anticipated visit that follow-up questionnaires would be completed would be calculated off the Early Follow-up Visit date (=\>150 days). Prior use of an Eligible Medication\*\* does not exclude a patient from an Early Follow-Up visit.
- Eligible Medications are biologics, biosimilars, and JAK-inhibitors FDA-approved for the treatment of RA. Prior use of an Eligible Medication does not exclude a patient from enrollment
Key Trial Info
Start Date :
February 1 2002
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2100
Estimated Enrollment :
91758 Patients enrolled
Trial Details
Trial ID
NCT01402661
Start Date
February 1 2002
End Date
December 1 2100
Last Update
October 2 2025
Active Locations (1)
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1
CorEvitas, LLC
Waltham, Massachusetts, United States, 02451