A Study To Investigate And Describe The Treatment Patterns And Effect Of Tofacitinib Indicators For Patients With Rheumatoid Arthritis

NCT04721808

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.
Rheumatoid Arthritis
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

- Enrolled in the Corrona RA Registry and initiated tofacitinib on or after November 2012

- Initiate tofacitinib (defined as first ever use of tofacitinib) at the Corrona enrollment visit or at a Corrona follow-up visit from November 2012 onward.

- Have CDAI measured at baseline

- Have at least a 6-month follow-up visit and CDAI measured at the 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 Investigate And Describe The Treatment Patterns And Effect Of Tofacitinib Indicators For Patients With Rheumatoid Arthritis
Official Title Treatment Patterns and 6 and 12-Month Effectiveness of Tofacitinib in the Corrona Rheumatoid Arthritis Registry
Brief Summary This study is to investigate and describe the treatment patterns and effect of tofacitinib indicators for patients with Rheumatoid Arthritis (RA) assessing real world patient data entered in the Corrona RA Registry on or after November 2012
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 Data will be collected from the Corrona RA Registry. The Corrona registry is a prospective, multicenter, observational disease-based registry launched in 2001.
Condition Arthritis, Rheumatoid
Intervention Not Provided
Study Groups/Cohorts Patients with Rheumatoid Arthritis (RA)
Patients receiving tofacitinib from the Corrona RA Registry from November 2012 onward
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: January 19, 2021)
1
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 31, 2022
Estimated Primary Completion Date January 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Enrolled in the Corrona RA Registry and initiated tofacitinib on or after November 2012
  • Initiate tofacitinib (defined as first ever use of tofacitinib) at the Corrona enrollment visit or at a Corrona follow-up visit from November 2012 onward.
  • Have CDAI measured at baseline
  • Have at least a 6-month follow-up visit and CDAI measured at the 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 NCT04721808
Other Study ID Numbers A3921379
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 April 2021