Comparative Analysis of Outcomes Among Patients Treated With Xeljanz vs Biologics
NCT03964649
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Adult Trials: 18+ Years
- At least one claim for methotrexate during the variable-length pre-index period.
- At least one claim for tofacitinib or bDMARDs between 01 February 2016 and 31 July 2019 (the identification period).
- Patients with claims for other conditions for which bDMARDs are used during the
one-year pre-index period or on the index date: ankylosing spondylitis, Crohn's
disease, psoriasis, psoriatic arthritis, or ulcerative colitis will be excluded from
the study.
- Patients with evidence of the index medication during the one-year pre-index period
will be removed from the analysis. Patients will be allowed to have been treated with
(other) bDMARDs during the one-year pre-index period.
- Patients with more than 1 bDMARD or bDMARD with tofacitinib filled on the index date
will be removed from the study.
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| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title | Comparative Analysis of Outcomes Among Patients Treated With Xeljanz vs Biologics | ||||
| Official Title | Comparative Analysis of Outcomes Among Rheumatoid Arthritis Patients Treated With Xeljanz Versus Biologic DMARDs Using a United States Healthcare Claims Database | ||||
| Brief Summary | To compare rheumatoid arthritis (RA) patient characteristics, adherence, and costs between patients treated with tofacitinib (IR, XR and combined groups) to patients treated with each of the bDMARDs. | ||||
| 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 | This study will utilize the de-identified claims data in the Truven Health MarketScan Research Database. | ||||
| Condition | Arthritis, Rheumatoid | ||||
| Intervention | Not Provided | ||||
| Study Groups/Cohorts | Truven Health MarketScan Research Database
To compare RA-related costs among patients treated with tofacitinib (IR, XR and combined groups) to patients treated with each of the bDMARDs (individually, as well as to TNFi and to non-TNFi each combined as groups). | ||||
| 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 | 1 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | April 6, 2020 | ||||
| Actual Primary Completion Date | April 6, 2020 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| 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 | NCT03964649 | ||||
| Other Study ID Numbers | A3921305 | ||||
| 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 |
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| PRS Account | Pfizer | ||||
| Verification Date | May 2020 | ||||