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NCT01402661Enrolling by invitation

CorEvitas Rheumatoid Arthritis (RA) Drug Safety & Effectiveness Registry

Source: ClinicalTrials.gov · Last updated 2 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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 rheumatologists across North America. Secondary objectives include analyzing the epidemiology and natural history of the disease, its comorbidities, and current treatment practices.

Status (registry)
Enrolling by invitation
Study type
Observational
Enrollment
91758 (estimated)
First submitted
25 Jul 2011
Start date
Feb 2002
Primary completion date
Dec 2100
Lead sponsor
CorEvitas
NCT number
NCT01402661

What you commit to

  • Study type: Observational
  • Planned participants: 91758
  • From Feb 2002 to the primary completion date, Dec 2100
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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.

Other

  • The patient must not:

Who the study is looking for

  • 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").

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CorEvitas, LLC
Coordinator of this site? Confirm its status
WalthamUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.