Clinical trial NCT04047121: A Study to Evaluate Patient Characteristics and Treatment Patterns Among Rheumatoid Arthritis Patients
Official title: Evaluation of Xeljanz Access Barriers Via Patient OOP Costs and TNFi Cycling
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-08-06
Enrollment: 1349
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients

Brief summary: This is a retrospective cohort study to evaluate patient characteristics, treatment patterns including a 6-factor effectiveness proxy measure, health care resource use and associated costs among Rheumatoid Arthritis patients initiating treatment comparator groups of interest between January 2014 and September 2016 across three United States insurance claims databases.


Eligibility criteria: Inclusion Criteria:

* first pharmacy claim for Tofacitinib and then Etanercept or Adalimumab between Jan 2014 and Sep 2016 represents the index claim
* First, select patients receiving ≥1 Tofacitinib pharmacy claim (Jan 2014-Sep 2016) who did not have a Tofacitinib claim anytime prior to index
* Patients do have \>1 advanced therapy filled on index date
* Physician diagnosis of Rheumatoid Arthritis (in any position) during the 1-year pre-index period, or on the index date
* Age 18+ years at index

Exclusion Criteria:

-None

Primary outcomes:
measure: Percentage of Participants Who Were Persistent With Index Medication During 12 Months Post-index Date
timeFrame: During 12 months post-index date
measure: Percentage of Participants Who Immediately Switched Index Medication During 12 Months Post-index Date
timeFrame: During 12 months post-index date
measure: Percentage of Participants Who Discontinued Then Switched Index Medication During 12 Months Post-index Date
timeFrame: During 12 months post-index date
measure: Percentage of Participants Who Discontinued Then Restarted Index Medication During 12 Months Post-index Date
timeFrame: During 12 months post index date
measure: Percentage of Participants Who Discontinued Without Switching or Restarting Index Medication During 12 Months Post-index Date
timeFrame: During 12 months post index date
Secondary outcomes:
measure: Percentage of Participants Who Switched Index Medication Any Time During 12 Months Post-index Date
timeFrame: During 12 months post-index date
measure: Mean of Number of Days to Immediate Switch From Index Medication During 12 Months Post-index Date
timeFrame: During 12 months post-index date
measure: Mean of Number of Days to Immediate or Delayed Switch Index Medication During 12 Months Post-index Date
timeFrame: During 12 month post-index date
measure: Mean of Number of Days to Discontinue Index Medication During 12 Months Post-index Date
timeFrame: During 12 months post-index date
measure: Duration of Index Medication Persistent Therapy During 12 Months Post-index Date
timeFrame: During 12 months post-index date
measure: Percentage of Participants Who Were Persistent With Main Non-Biologic Disease Modifying Antirheumatic Drugs (NB-DMARD) During 12 Months Post-index Date: Combination Therapy
timeFrame: During 12 months post-index date
measure: Percentage of Participants Who Immediately Switched From Main NB-DMARDs During 12 Months Post-index Date: Combination Therapy
timeFrame: During 12 months post-index date
measure: Percentage of Participants Who Discontinued Then Switched From Main NB-DMARDs During 12 Months Post-index Date: Combination Therapy
timeFrame: During 12 months post-index date
measure: Percentage of Participants Who Discontinued Then Restarted Main NB-DMARDs During 12 Months Post-index Date: Combination Therapy
timeFrame: During 12 months post-index date
measure: Percentage of Participants Who Discontinued Without Switching or Restarting Main NB-DMARDs During 12 Months Post-index Date: Combination Therapy
timeFrame: During 12 months post-index date
measure: Percentage of Participants Who Initiated Index Medication as Monotherapy and Eventually Added NB-DMARDs During 12 Months Post-index Date
timeFrame: During 12 months post-index date
measure: Percentage of Participants Who Met Adherence Effectiveness Criteria During 12 Months Post-index Date
timeFrame: During 12 months post-index date
measure: Percentage of Participants Who Met Dose Escalation Effectiveness Criteria During 12 Months Post-index Date
timeFrame: During 12 months post-index date
measure: Percentage of Participants Who Met Switched Effectiveness Criteria During 12 Months Post-index Date
timeFrame: During 12 months post-index date
measure: Percentage of Participants Who Met NB-DMARD Effectiveness Criteria During 12 Months Post-index Date
timeFrame: During 12 months post-index date
measure: Percentage of Participants Who Met Oral Glucocorticoid Effectiveness Criteria During 12 Months Post-index Date
timeFrame: During 12 months post-index date
measure: Percentage of Participants Who Met Infusion Glucocorticoid Effectiveness Criteria During 12 Months Post-index Date
timeFrame: During 12 months post-index date
measure: Mean of Rheumatoid Arthritis (RA) Related Inpatient Visits During 12 Months Pre-index Date
timeFrame: During 12 months pre-index date
measure: Mean of Rheumatoid Arthritis Related Emergency Department (ED) Visits During 12 Months Pre-Index Date
timeFrame: During 12 months pre-index date
measure: Mean of Rheumatoid Arthritis Related Outpatient Visits During 12 Months Pre-index Date
timeFrame: During 12 months pre-index date
measure: Mean of Rheumatoid Arthritis-Related Pharmacy Visits During 12 Months Pre-index Date
timeFrame: During 12 months pre-index date
measure: Mean of Rheumatoid Arthritis Related Inpatient Visits During 12 Months Post-index Date
timeFrame: During 12 months post-index date
measure: Mean of Rheumatoid Arthritis Related Emergency Department (ED) Visits During 12 Months Post-index Date
timeFrame: During 12 months post-index date
measure: Mean of Rheumatoid Arthritis Related Outpatient Visits During 12 Months Post-index Date
timeFrame: During 12 months post-index date
measure: Mean of Rheumatoid Arthritis Related Pharmacy Visits During 12 Months Post-index Date
timeFrame: During 12 months post-index date
measure: Mean of All Cause Inpatient Visits During 12 Months Pre-Index Date
timeFrame: During 12 months pre-index date
measure: Mean of All Cause Emergency Department (ED) Visits During 12 Months Pre-index Date
timeFrame: During 12 months pre-index date
measure: Mean of All Cause Outpatient Visits During 12 Months Pre-Index Date
timeFrame: During 12 months pre-index date
measure: Mean of All Cause Pharmacy Visits During 12 Months Pre-index Date
timeFrame: During 12 months pre-index date
measure: Mean of All Cause Inpatient Visits During 12 Months Post-index Date
timeFrame: During 12 months post-index date
measure: Mean of All Cause Emergency Department (ED) Visits During 12 Months Post-index Date
timeFrame: During 12 months post-index date
measure: Mean of All Cause Outpatient Visits During 12 Months Post-index Date
timeFrame: During 12 months post-index date
measure: Mean of All Cause Pharmacy Visits During 12 Months Post-index Date
timeFrame: During 12 months post-index date
measure: Mean of Rheumatoid Arthritis Related Total Health Care Cost During 12 Months Pre-index Date
timeFrame: During 12 months pre-index date
measure: Mean of Rheumatoid Arthritis Related Total Health Care Cost During 12 Months Post-index Date
timeFrame: During 12 months post-index date
measure: All Cause Total Health Care Cost During 12 Months Pre-index Date
timeFrame: During 12 months pre-index date
measure: All Cause Total Health Care Cost During 12 Months Post-index Date
timeFrame: During 12 months post-index date
Other outcomes:
Locations:
city: Collegeville
country: United States
facility: Pfizer
state: Pennsylvania
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: