Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2025-12-24 @ 11:52 AM
NCT ID:
NCT01402661
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01402661
Study Brief:
Protocol Section:
NCT01402661