Comparative Effectiveness Of Tumor Necrosis Factor Inhibitors And Tofacitinib Use In Earlier Lines Of Therapy And Use As Monotherapy.

Pfizer

Status: Completed

Conditions: Arthritis Rheumatoid

Treatments: Drug: Tofacitinib

Study type: Observational

Funder types: Industry

Identifiers

NCT04721821

A3921389

Details and patient eligibility

About

This study is to investigate if there has been a shift in treatment with tofacitinib, assessing real world patient data and entered in the Corrona registry between 2016 and 2020.

Enrollment: 7,807 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• RA patients in Corrona initiating tofacitinib or a TNF biologic (adalimumab, etanercept, infliximab, golimumab, certolizumab pegol) after 06 November 2012 (market approval of Tofacitinib) during follow-up in Corrona with no prior use of tofacitinib. Only the patient's first initiation after 06 November 2012 will be included in the analysis
• Have a 6 and / or 12-month follow-up visit (with +/- 2 month window)
• Have Clinical Disease Activity Index (CDAI) measures at baseline and at the follow-up visit

Exclusion criteria

• Patients who have not failed methotrexate (MTX) or another csDMARD (ie 1st line initiators)

Trial design

7,807 participants in 1 patient group

Patients with Rheumatoid Arthritis (RA)

Treatment:

Drug: Tofacitinib