Status:
COMPLETED
Comparative Analysis of Adherence and Effectiveness Outcomes Between Rheumatoid Arthritis (RA) Patients Treated With Tofacitinib Modified Release (MR)
Lead Sponsor:
Pfizer
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
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).
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 12 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 25 2019
Estimated Enrollment :
1057 Patients enrolled
Trial Details
Trial ID
NCT04018001
Start Date
April 12 2019
End Date
April 25 2019
Last Update
April 3 2024
Active Locations (1)
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1
Pfizer
New York, New York, United States, 10017