Clinical trial NCT03964649: Comparative Analysis of Outcomes Among Patients Treated With Xeljanz vs Biologics
Official title: Comparative Analysis of Outcomes Among Rheumatoid Arthritis Patients Treated With Xeljanz Versus Biologic DMARDs Using a United States Healthcare Claims Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Rheumatoid
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-05-28
Enrollment: 7308
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will utilize the de-identified claims data in the Truven Health MarketScan Research Database.

Brief summary: To compare rheumatoid arthritis (RA) patient characteristics, adherence, and costs between patients treated with tofacitinib (IR, XR and combined groups) to patients treated with each of the bDMARDs.


Eligibility criteria: Inclusion Criteria:

* At least one claim for methotrexate during the variable-length pre-index period.
* At least one claim for tofacitinib or bDMARDs between 01 February 2016 and 31 July 2019 (the identification period).

Exclusion Criteria:

* Patients with claims for other conditions for which bDMARDs 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) bDMARDs during the one-year pre-index period.
* Patients with more than 1 bDMARD or bDMARD with tofacitinib filled on the index date will be removed from the study.

Primary outcomes:
measure: Number of Participants Who Were on Combination Therapy and Monotherapy During 90 Days After Index Date
timeFrame: Within 90 days after index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Number of Participants for Each of the Most Commonly Used Medications During the 12 Months Post-index Date
timeFrame: During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Number of Participants Who Used Opioids and Non-steroidal Anti-inflammatory Drug (NSAIDs) During 12 Months Post Index Period
timeFrame: During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Mean Number of Pharmacy Claims for Opioids and NSAIDS During 12 Months Post Index Period
timeFrame: During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Mean Number of Days From The Index Date to the First Opioid and NSAIDs Claim During 12 Months Post Index Period
timeFrame: During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Number of Participants Who Used Opioids and NSAIDs While Persistent and After Persistent With Index Medication During 12 Months Post Index Period
timeFrame: During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Number of Participants Who Used Oral Corticosteroids During 12 Months Post-Index Period
timeFrame: During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Number of Participants Who Were Non-persistent to Index Medication
timeFrame: During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Number of Participants Who Switched Immediately From Index Medication
timeFrame: During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Number of Participants Who Discontinued Then Restarted Index Medication
timeFrame: During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Number of Participants Who Discontinued Then Switched From Index Medication
timeFrame: During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Number of Participants Who Discontinued Without Switching or Restarting Index Medication
timeFrame: During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Number of Participants Who Switched Any Time From Index Medication
timeFrame: During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Number of Participants Who Re-started Index Medication at Any Time
timeFrame: During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Mean Medication Possession Ratio (MPR) for Methotrexate
timeFrame: During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Proportion of Days Covered (PDC)
timeFrame: During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Addition of Conventional Synthetic Disease-modifying Antirheumatic Drug (Cs-DMARDs) in Participants With Monotherapy
timeFrame: During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Adherence to Cs-DMARDs in Participants With Combination Therapy
timeFrame: During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Number of Participants Who Met Different Medication Effectiveness Criteria
timeFrame: During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: All Cause Inpatient Visits Costs, Outpatient Visits Costs and Emergency Room (ER) Visits Costs During 12 Months Post Index Period
timeFrame: During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Rheumatoid Arthritis (RA) Related Inpatient Visits Costs, Outpatient Visits Costs and Emergency Room (ER) Visits Costs During 12 Months Post Index Period
timeFrame: During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: All Cause Total Health Care Costs, Medical Costs, Pharmacy Costs During 12 Months Post-Index Period
timeFrame: During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: RA Related Total Health Care Costs, Medical Costs, Pharmacy Costs During 12 Months Post-Index Period
timeFrame: During 12 months post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Total All Cause Monthly Health Care Cost at Month 1 Post Index Date
timeFrame: Month 1 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Total All Cause Monthly Health Care Cost at Month 2 Post Index Date
timeFrame: Month 2 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Total All Cause Monthly Health Care Cost at Month 3 Post Index Date
timeFrame: Month 3 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Total All Cause Monthly Health Care Cost at Month 4 Post Index Date
timeFrame: Month 4 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Total All Cause Monthly Health Care Cost at Month 5 Post Index Date
timeFrame: Month 5 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Total All Cause Monthly Health Care Cost at Month 6 Post Index Date
timeFrame: Month 6 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Total All Cause Monthly Health Care Cost at Month 7 Post Index Date
timeFrame: Month 7 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Total All Cause Monthly Health Care Cost at Month 8 Post Index Date
timeFrame: Month 8 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Total All Cause Monthly Health Care Cost at Month 9 Post Index Date
timeFrame: Month 9 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Total All Cause Monthly Health Care Cost at Month 10 Post Index Date
timeFrame: Month 10 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Total All Cause Monthly Health Care Cost at Month 11 Post-index Date
timeFrame: Month 11 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Total All Cause Monthly Health Care Cost at Month 12 Post Index Date
timeFrame: Month 12 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Total RA Related Monthly Health Care Cost at Month 1 Post Index Date
timeFrame: Month 1 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Total RA Related Monthly Health Care Cost at Month 2 Post Index Date
timeFrame: Month 2 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Total RA Related Monthly Health Care Cost at Month 3 Post Index Date
timeFrame: Month 3 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Total RA Related Monthly Health Care Cost at Month 4 Post Index Date
timeFrame: Month 4 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Total RA Related Monthly Health Care Cost at Month 5 Post Index Date
timeFrame: Month 5 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Total RA Related Monthly Health Care Cost at Month 6 Post Index Date
timeFrame: Month 6 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Total RA Related Monthly Health Care Cost at Month 7 Post Index Date
timeFrame: Month 7 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Total RA Related Monthly Health Care Cost at Month 8 Post Index Date
timeFrame: Month 8 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Total RA Related Monthly Health Care Cost at Month 9 Post Index Date
timeFrame: Month 9 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Total RA Related Monthly Health Care Cost at Month 10 Post Index Date
timeFrame: Month 10 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Total RA Related Monthly Health Care Cost at Month 11 Post-index Date
timeFrame: Month 11 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
measure: Total RA Related Monthly Health Care Cost at Month 12 Post Index Date
timeFrame: Month 12 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Pfizer
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: