Clinical trial NCT04267380: A Study To Compare The Effectiveness Of Tofacitinib 11 Mg Once A Day To Tofacitinib 5 Mg Twice A Day
Official title: Compare Effectiveness of Tofacitinib 11 mg QD to Tofacitinib 5 mg BID
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis Rheumatoid
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-02-12
Enrollment: 298
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients prescribed Tofacitinib in routine clinical practice

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Achieving Minimally Clinically Important Difference (MCID) Improvement From Baseline Upto 6 Months
timeFrame: Baseline Up to 6 Months
Secondary outcomes:
measure: Change From Baseline in Clinical Disease Activity Index (CDAI) at Month 6
timeFrame: Baseline, Month 6
measure: Number of Participants Achieving Remission at Month 6 (All Participants)
timeFrame: Month 6
measure: Number of Participants Achieving Remission at Month 6 (For Participants With Baseline CDAI >2.8)
timeFrame: Month 6
measure: Number of Participants Achieving Low Disease Activity at Month 6 (All Participants)
timeFrame: Month 6
measure: Number of Participants Achieving Low Disease Activity at Month 6 (Participants With Baseline CDAI >10)
timeFrame: Month 6
measure: Number of Participants With Decrease From Baseline in Modified Health Assessment Questionnaire (mHAQ) Score at Month 6
timeFrame: Month 6
measure: Number of Participants With Decrease From Baseline in Health Assessment Questionnaire (HAQ) Score at Month 6
timeFrame: Month 6
measure: Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Month 6: Dichotomous Variable
timeFrame: Baseline, Month 6
measure: Change From Baseline in Modified Health Assessment Questionnaire (mHAQ) Score at Month 6
timeFrame: Baseline, Month 6
measure: Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Month 6
timeFrame: Baseline, Month 6
measure: Change From Baseline in Modified Disease Activity Score Based on 28-joints Count (mDAS28) at Month 6
timeFrame: Baseline, Month 6
measure: Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) Erythrocyte Sedimentation Rate (ESR) at Month 6
timeFrame: Baseline, Month 6
measure: Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) C- Reactive Protein (CRP) at 6 Month
timeFrame: Baseline, 6 months
measure: Change From Baseline in Participant Pain Score at Month 6
timeFrame: Baseline, Month 6
measure: Change From Baseline in Participant Fatigue Score at Month 6
timeFrame: Baseline, Month 6
measure: Change From Baseline in European Quality of Life- 5 Dimension (EQ-5D) Index at Month 6
timeFrame: Baseline, Month 6
measure: Number of Participants Achieving Modified American College of Rheumatology 20% (mACR20) Response
timeFrame: Month 6
measure: Number of Participants Achieving Modified American College of Rheumatology 50% (mACR50) Response
timeFrame: Month 6
measure: Number of Participants Achieving Modified American College of Rheumatology 70% (mACR70) Response
timeFrame: Month 6
Other outcomes:
Locations:
city: New York
country: United States
facility: Pfizer
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Cohen SB, Greenberg JD, Harnett J, Madsen A, Smith TW, Gruben D, Zhang R, Lukic T, Woolcott J, Dandreo KJ, Litman HJ, Blachley T, Lenihan A, Chen C, Rivas JL, Dougados M. Real-World Evidence to Contextualize Clinical Trial Results and Inform Regulatory Decisions: Tofacitinib Modified-Release Once-Daily vs Immediate-Release Twice-Daily for Rheumatoid Arthritis. Adv Ther. 2021 Jan;38(1):226-248. doi: 10.1007/s12325-020-01501-z. Epub 2020 Oct 9.