Comparing the Effectiveness of a Treat-to-target (T2T) Disease Management Strategy vs. Routine Care (RC) in Adult Patients With Moderate to Severe Rheumatoid Arthritis (RA) Treated With Subcutaneous Abatacept (Orencia - SC) (ABC)

Bristol-Myers Squibb (BMS)

Status

Completed

Conditions

Rheumatoid Arthritis

Treatments

Other: Non-Interventional

Study type

Observational

Funder types

Industry

Identifiers

NCT03274141

IM101-331

Details and patient eligibility

About

This is a 12 month prospective, multicenter, post-marketing, observational study to compare the effectiveness of a treat-to-target (T2T) disease management strategy vs. routine care (RC) in adult patients with moderate to severe rheumatoid arthritis (RA) treated with subcutaneous abatacept (Orencia - SC). Patients completing the study will be offered to participate in a 12-month extension of their follow-up provided that this is in agreement with the judgment of the treating physician.

Enrollment

281 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

18 years of age or older.
Active moderate to severe RA, defined as CDAI > 10.
The treating physician has made the decision to initiate treatment with SC abatacept in accordance with the Canadian product monograph.
Patient has provided a written informed consent and is able to complete the survey requirements.
Patient fulfills the reimbursement criteria for treatment with SC abatacept under provincial or private health insurance reimbursement coverage.

Exclusion criteria

Has received abatacept (SC or IV) prior to the enrolment visit.
Has failed more than one prior biologic DMARD therapy
Has a history of autoimmune disease or of any joint inflammatory disease other than RA with the exception of concomitant secondary Sjogren's syndrome.
Is participating in an ongoing clinical trial and/or has received treatment with an investigational agent within 4 weeks before starting treatment with SC abatacept.
Is participating in another industry-sponsored observational study.
Patients participating to non-industry related registries or other data collection studies can be included
Presence of any condition that, in the opinion of the treating physician, prohibits the patient from participating in the study or obscures the assessment of RA treatment.