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Comparative Analysis of Outcomes Among Patients Treated With Xeljanz vs Biologics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03964649
Recruitment Status : Completed
First Posted : May 28, 2019
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease
Arthritis, Rheumatoid

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Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparative Analysis of Outcomes Among Rheumatoid Arthritis Patients Treated With Xeljanz Versus Biologic DMARDs Using a United States Healthcare Claims Database
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : April 6, 2020
Actual Study Completion Date : April 6, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
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).



Primary Outcome Measures :
  1. To compare rheumatoid arthritis (RA)-related costs among patients treated with tofacitinib to patients treated with each of the biologics [ Time Frame: 4 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study will utilize the de-identified claims data in the Truven Health MarketScan Research Database.
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03964649


Locations
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United States, New York
Pfizer
New York, New York, United States, 10017
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03964649    
Other Study ID Numbers: A3921305
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020
Individual Participant Data (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/data_requests.
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases