CorEvitas Rheumatoid Arthritis (RA) Drug Safety & Effectiveness Registry

Korábbi kezelés

• 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

Más betegség

• 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.

Egyéb

• The patient must not:

• 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.
• 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").