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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

298 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-30

Study Completion Date

2019-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Arthritis Rheumatoid

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Corrona US RA Registry 11 mg

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

No interventions assigned to this group

Corrona US RA Registry 5 mg

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

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No