Comparative Analysis of Outcomes Among Patients Treated With Xeljanz vs Biologics
NCT03964649
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
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.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Birmingham, Alabama
- Montpellier,
- Lille,
| 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:
| ||||
| 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 | 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 |
| ||||
| PRS Account | Pfizer | ||||
| Verification Date | May 2020 | ||||