Registry for Rheumatoid Arthritis Treatment Safety and Effectiveness

CorEvitas Rheumatoid Arthritis (RA) Drug Safety & Effectiveness Registry

This study is trying to see how safe and effective current rheumatoid arthritis treatments are for patients seeing rheumatologists in North America.

Quick facts

• Study type: Observational
• Enrollment: 91758 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: CorEvitas (network)
• Drugs / interventions: methotrexate, prednisone
• Locations: 1 site (Waltham, Massachusetts)
• Trial ID: NCT01402661 on ClinicalTrials.gov

What this trial studies

This prospective, non-interventional registry aims to study the safety and effectiveness of approved treatments for rheumatoid arthritis (RA) among patients treated by rheumatologists in North America. It systematically collects data on treatment patterns, disease progression, and patient-reported outcomes through structured questionnaires completed during routine clinical visits. The registry also analyzes the epidemiology of RA, its comorbidities, and current treatment practices over time. Data is collected at six-month intervals to monitor adverse events and treatment effectiveness.

Who should consider this trial

Good fit: Ideal candidates for this registry are adults aged 18 and older who have been diagnosed with rheumatoid arthritis by a rheumatologist.

Not a fit: Patients with juvenile idiopathic arthritis, psoriatic arthritis, spondyloarthritis, or ankylosing spondylitis may not benefit from this registry.

Why it matters

Potential benefit: If successful, this registry could provide valuable insights into the safety and effectiveness of RA treatments, ultimately improving patient care and treatment strategies.

How similar studies have performed: Other observational registries have successfully provided insights into treatment effectiveness and safety in similar patient populations, indicating a strong precedent for this approach.

Eligibility criteria

Inclusion Criteria:

1. Be at least 18 years of age or older.
2. 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.
3. Have been diagnosed with rheumatoid arthritis by a rheumatologist.
4. 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 Criteria:

The patient must not:

1. 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.
2. 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.
3. 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:
4. 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

Where this trial is running

Waltham, Massachusetts

• CorEvitas, LLC — Waltham, Massachusetts, United States (RECRUITING)

Study contacts

• Study coordinator: Cathy Cheney

Conditions: Rheumatoid Arthritis, rheumatoid arthritis, psoriatic arthritis, disease registry