A Study to Evaluate Patient Characteristics and Treatment Patterns Among Rheumatoid Arthritis Patients
NCT04047121
Last updated date
ABOUT THIS STUDY
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.
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
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
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 | 1349 | ||||
| Original Actual Enrollment | 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:
Exclusion Criteria: -None | ||||
| Sex/Gender |
| ||||
| 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 |
| ||||
| Responsible Party | Pfizer | ||||
| Study Sponsor | Pfizer | ||||
| Collaborators | Not Provided | ||||
| Investigators |
| ||||
| PRS Account | Pfizer | ||||
| Verification Date | September 2020 | ||||