A Study to Evaluate Patient Characteristics and Treatment Patterns Among Rheumatoid Arthritis Patients

NCT04047121

Last updated date
Study Location
Pfizer
Collegeville, Pennsylvania, 19426, 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

- first pharmacy claim for Tofacitinib and then Etanercept or Adalimumab between Jan 2014 and Sep 2016 represents the index claim

- First, select patients receiving ≥1 Tofacitinib pharmacy claim (Jan 2014-Sep 2016) who did not have a Tofacitinib claim anytime prior to index

- Patients do have >1 advanced therapy filled on index date

- Physician diagnosis of Rheumatoid Arthritis (in any position) during the 1-year pre-index period, or on the index date

- Age 18+ years at index

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


-None

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Advanced Information
Descriptive Information
Brief Title A Study to Evaluate Patient Characteristics and Treatment Patterns Among Rheumatoid Arthritis Patients
Official Title Evaluation of Xeljanz Access Barriers Via Patient OOP Costs and TNFi Cycling
Brief Summary This is a retrospective cohort study to evaluate patient characteristics, treatment patterns including a 6-factor effectiveness proxy measure, health care resource use and associated costs among Rheumatoid Arthritis patients initiating treatment comparator groups of interest between January 2014 and September 2016 across three United States insurance claims databases.
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 Probability Sample
Study Population Patients
Condition Rheumatoid Arthritis
Intervention Not Provided
Study Groups/Cohorts Truven Health MarketScan
The Truven Health MarketScan Research Databases reflects the combined healthcare service use of individuals covered by Truven Health clients (including employers, health plans, and hospitals) nationwide.
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 Completed
Actual Enrollment
 (submitted: September 22, 2020)
1349
Original Actual Enrollment
 (submitted: August 4, 2019)
1
Actual Study Completion Date October 21, 2019
Actual Primary Completion Date October 21, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • first pharmacy claim for Tofacitinib and then Etanercept or Adalimumab between Jan 2014 and Sep 2016 represents the index claim
  • First, select patients receiving ?1 Tofacitinib pharmacy claim (Jan 2014-Sep 2016) who did not have a Tofacitinib claim anytime prior to index
  • Patients do have >1 advanced therapy filled on index date
  • Physician diagnosis of Rheumatoid Arthritis (in any position) during the 1-year pre-index period, or on the index date
  • Age 18+ years at index

Exclusion Criteria:

-None

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 NCT04047121
Other Study ID Numbers A3921346
Has Data Monitoring Committee Not Provided
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 September 2020