A Study To Compare The Effectiveness Of Tofacitinib 11 Mg Once A Day To Tofacitinib 5 Mg Twice A Day

Pfizer

Status: Completed

Conditions: Arthritis Rheumatoid

Study type: Observational

Funder types: Industry

Identifiers

NCT04267380

A3921359

Details and patient eligibility

About

It is hypothesized that patients prescribed tofacitinib 11 mg Modified Release (MR) formulation once daily (QD) will achieve similar benefit to those prescribed tofacitinib 5 mg twice a day (BID) dosage in real world use. This study will therefore seek to compare the effectiveness of the MR 11 mg QD regimen to the IR 5 mg BID regimen for the treatment of RA in a real-world registry of RA patients.

Enrollment: 298 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• All US Corrona RA Registry patients who initiated tofacitinib 5 mg twice a day (BID) or tofacitinib 11 mg once daily (QD) after it became available in February 2016
• Patients must have a follow-up visit at 6 months (+/- 3 months) after tofacitinib initiation. These 6 month visits are part of routine practice and is not associated with this protocol.
• Patients must have a valid clinical disease activity index (CDAI) at initiation and at 6-month follow-up visit

Exclusion criteria

• There are no exclusion criteria for this study.

Trial design

298 participants in 2 patient groups

Corrona US RA Registry 11 mg

Description:

patients with RA who have been exposed to tofacitinib 11 mg QD tablet

Corrona US RA Registry 5 mg

Description:

patients with RA who have been exposed to tofacitinib 5 mg BID tablet