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

NCT04267380

Last updated date
Study Location
Pfizer
New York, New York, 10017, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Arthritis Rheumatoid
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- There are no exclusion criteria for this study.

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Advanced Information
Descriptive Information
Brief Title 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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients prescribed Tofacitinib in routine clinical practice
Condition Arthritis Rheumatoid
Intervention Not Provided
Study Groups/Cohorts
  • Corrona US RA Registry 11 mg
    patients with RA who have been exposed to tofacitinib 11 mg QD tablet
  • Corrona US RA Registry 5 mg
    patients with RA who have been exposed to tofacitinib 5 mg BID tablet
Publications * 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. 2020 Oct 9. doi: 10.1007/s12325-020-01501-z. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 28, 2020)
298
Original Actual Enrollment
 (submitted: February 10, 2020)
1
Actual Study Completion Date August 31, 2019
Actual Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study:All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04267380
Other Study ID Numbers A3921359
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2020