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Comparative Analysis of Adherence and Effectiveness Outcomes Between Rheumatoid Arthritis (RA) Patients Treated With Tofacitinib Modified Release (MR)

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ClinicalTrials.gov Identifier: NCT04018001
Recruitment Status : Completed
First Posted : July 12, 2019
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
The purpose of this study is to compare adherence, persistence, and effectiveness among patients initiating tofacitinib Modified Release (MR) with tofacitinib Immediate Release (IR).

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 Adherence and Effectiveness Outcomes Between Rheumatoid Arthritis (RA) Patients Treated With Tofacitinib Modified Release (MR) Formulation 11mg Once Daily (QD) and Tofacitinib Immediate Release (IR) Formulation 5 mg Twice Daily (BID) Within a United States (US) Healthcare Claims Database
Actual Study Start Date : April 12, 2019
Actual Primary Completion Date : April 25, 2019
Actual Study Completion Date : April 25, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Tofacitinib

Group/Cohort
Truven Health MarketScan Research Database
individuals who are privately insured and with Medicare Supplemental insurance



Primary Outcome Measures :
  1. Effectiveness over 12 months of follow up using a validated criteria-based algorithm [ Time Frame: 12 months ]
    Algorithm defined persistence measure based on a combination of high adherence, dose escalation, treatment switch, addition of csDMARD, use of oral or injectable glucocorticoids

  2. Effectiveness over 12 months of follow up using a persistence based measure of treatment duration (days) and proportion [ Time Frame: 12 months ]
    Persistence defined as number of days between index and last prescription followed by a gap of 60 days

  3. Adherence over 12 months of follow up [ Time Frame: 12 months ]
    Adherence based on medication possession ratio and proportion of days covered.



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
Individuals initiating tofacitinib
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT04018001


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: NCT04018001     History of Changes
Other Study ID Numbers: A3921349
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 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: 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
Tofacitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action