Comparative Analysis of Adherence and Effectiveness Outcomes Between Rheumatoid Arthritis (RA) Patients Treated With Tofacitinib Modified Release (MR)
NCT ID: NCT04018001
Last Updated: 2024-04-03
Study Results
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View full resultsBasic Information
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COMPLETED
1057 participants
OBSERVATIONAL
2019-04-12
2019-04-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Truven Health MarketScan Research Database
individuals who are privately insured and with Medicare Supplemental insurance
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer
New York, New York, United States
Countries
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References
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Cohen SB, Greenberg JD, Harnett J, Madsen A, Smith TW, Gruben D, Zhang R, Lukic T, Woolcott J, Dandreo KJ, Litman HJ, Blachley T, Lenihan A, Chen C, Rivas JL, Dougados M. Real-World Evidence to Contextualize Clinical Trial Results and Inform Regulatory Decisions: Tofacitinib Modified-Release Once-Daily vs Immediate-Release Twice-Daily for Rheumatoid Arthritis. Adv Ther. 2021 Jan;38(1):226-248. doi: 10.1007/s12325-020-01501-z. Epub 2020 Oct 9.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A3921349
Identifier Type: -
Identifier Source: org_study_id
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