CorEvitas Rheumatoid Arthritis (RA) Drug Safety & Effectiveness Registry

Description

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.

Conditions

Rheumatoid Arthritis

Study Overview

Study Details

Study overview

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.

CorEvitas Rheumatoid Arthritis (RA) Drug Safety & Effectiveness Registry

CorEvitas Rheumatoid Arthritis (RA) Drug Safety & Effectiveness Registry

Condition
Rheumatoid Arthritis
Intervention / Treatment

-

Contacts and Locations

Waltham

CorEvitas, LLC, Waltham, Massachusetts, United States, 02451

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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:
  • 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.
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

CorEvitas,

Joel Kremer, MD, STUDY_DIRECTOR, Center for Rheumatology

Study Record Dates

2100-12