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

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NCT04047121

Last updated on December 5, 2019
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FOR MORE INFORMATION
Study Location
Pfizer
Collegeville, Pennsylvania, 19426 United States
See other locations
Contact
1-800-718-1021
[email protected]
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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

NCT04047121
Pfizer
Completed
A Study to Evaluate Patient Characteristics and Treatment Patterns Among Rheumatoid Arthritis Patients

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[email protected]

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Descriptive Information
Brief TitleA Study to Evaluate Patient Characteristics and Treatment Patterns Among Rheumatoid Arthritis Patients
Official TitleEvaluation of Xeljanz Access Barriers Via Patient OOP Costs and TNFi Cycling
Brief SummaryThis 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 DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationPatients
ConditionRheumatoid Arthritis
InterventionNot 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.
  • Optum Clinformatics
    Optum's ClinformaticsTM Data Mart (CDM) comes from a database of administrative health claims for members of a large national managed care company affiliated with Optum.
  • Pharmetrics Plus
    The PharMetrics Plus database is comprised of fully adjudicated medical and pharmacy claims.
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 StatusCompleted
Actual Enrollment
 (submitted: August 4, 2019)		1
Original Actual EnrollmentSame as current
Actual Study Completion DateOctober 21, 2019
Actual Primary Completion DateOctober 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
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesUnited States
Removed Location Countries  
 
Administrative Information
NCT NumberNCT04047121
Other Study ID NumbersA3921346
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot 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/da....
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateDecember 2019

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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