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Comparative Analysis of Outcomes Among Patients Initiating Xeljanz in Combination With Oral MTX Who Withdraw MTX Versus Continue MTX

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. Identifier: NCT03975790
Recruitment Status : Completed
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Information provided by (Responsible Party):

Brief Summary:
To address the objectives, a retrospective cohort design will be employed to evaluate patient characteristics, treatment patterns, medication effectiveness, and health care cost and utilization in RA patients newly initiating tofacitinib in combination with oral methotrexate (MTX)

Condition or disease
Rheumatoid Arthritis

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Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparative Analysis of Outcomes Among Patients Initiating Xeljanz in Combination With Oral MTX Who Withdraw MTX Versus Continue MTX Using a United States Healthcare Claims Database
Actual Study Start Date : May 29, 2018
Actual Primary Completion Date : October 2, 2018
Actual Study Completion Date : October 2, 2018

Resource links provided by the National Library of Medicine

Truven Health MarketScan Research Database
Compare treatment patterns including dosing, concomitant medication use, adherence, persistence, and switching among tofacitinb+MTX patients who withdraw MTX vs. persist with MTX or experience interrupted MTX

Primary Outcome Measures :
  1. Treatment persistence duration measured with index medication [ Time Frame: 12 months post treatment initiation ]
    Non-persistence will be identified based on a gap in treatment with the index medication or switching to another biologic in the 12 months post treatment initiation. Persistence with the index medication will be defined as not having a gap in therapy of at least 60 days between fills/infusions.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals who are privately insured and with Medicare Supplemental insurance

Inclusion Criteria:

  • At least one claim for tofacitinib between 01 January 2014 and 31 January 2017 (the identification period).
  • Presence of The International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9 CM) code for RA (in any position) during the one-year pre-index period or on the index date. ICD-9 = 714.0x-714.4x & 714.81 or ICD10 = M05.* & M06.0*-M06.3* or M06.8*-M06.9*.
  • At least 18 years old as of the index date.

Exclusion Criteria:

  • Patients with claims for other conditions for which biologics 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 biologics approved for RA (Tumor-Necrosis Factor-alpha inhibitors (TNFi) [adalimumab (Humira), etanercept (Enbrel), certolizumab pegol (Cimzia), golimumab (Simponi), infliximab (Remicade)] and non-TNFi's with alternative mechanisms of action [abatacept (Orencia), and rituximab (Rituxan), anakinra (Kineret), tocilizumab (Actemra)]) during the one-year pre-index period.

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 identifier (NCT number): NCT03975790

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United States, New York
New York, New York, United States, 10017
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer Identifier: NCT03975790     History of Changes
Other Study ID Numbers: A3921336
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
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:

Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action