Clinical trial NCT03975790: Comparative Analysis of Outcomes Among Patients Initiating Xeljanz in Combination With Oral MTX Who Withdraw MTX Versus Continue MTX
Official title: Comparative Analysis of Outcomes Among Patients Initiating Xeljanz in Combination With Oral MTX Who Withdraw MTX Versus Continue MTX Using a United States Healthcare Claims Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-06-05
Enrollment: 479
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who are privately insured and with Medicare Supplemental insurance

Brief summary: To address the objectives, a retrospective cohort design will be employed to evaluate patient characteristics, treatment patterns, medication effectiveness, and health care cost and utilization in RA patients newly initiating tofacitinib in combination with oral methotrexate (MTX)


Eligibility 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.

Primary outcomes:
measure: Number of Participants as Per Type of Insurance Plan
timeFrame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Number of Participants in Each Geographic Region
timeFrame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Number of Participants With Biologic Disease Modifying Antirheumatic Drug (bDMARD) Use During Pre-Index Period
timeFrame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Number of Participants With Biologic Disease Modifying Antirheumatic Drug (bDMARD) Use During Variable Length Pre-Index Period
timeFrame: During variable length pre-index period (1 year before the index date up to 5.2 years)
measure: Mean Number of Biologic Disease Modifying Antirheumatic Drug (bDMARD) Received During Pre-Index Period
timeFrame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Mean Number of Biologic Disease Modifying Antirheumatic Drug (bDMARD) Received During Variable Length Pre-Index Period
timeFrame: During variable length pre-index period (1 year before the index date up to 5.2 years)
measure: Number of Participants With Non-biologic Disease Modifying Antirheumatic Drug (NB-DMARD) Use During Pre-Index Period
timeFrame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Number of Participants With Non-Biologic Disease Modifying Antirheumatic Drug (NB-DMARD) Use During Variable Length Pre-Index Period
timeFrame: During variable length pre-index period (1 year before the index date up to 5.2 years)
measure: Mean Number of Non-Biologic Disease Modifying Antirheumatic Drug (NB-DMARD) Received During Pre-Index Period
timeFrame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Mean Number of Non-Biologic Disease Modifying Antirheumatic Drug (NB-DMARD) Received During Variable Length Pre-Index Period
timeFrame: During variable length pre-index period (1 year before the index date up to 5.2 years)
measure: Mean Quan-Charlson Comorbidity Score of Participants
timeFrame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Pre-Index Period
timeFrame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Post-Index Period
timeFrame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Mean Claims Based Index of RA Severity (CIRAS) Score During Pre-Index Period
timeFrame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Number of Participants With 25 Most Common Medications Use During Pre-Index Period
timeFrame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Number of Participants With 26 Most Common Medications Use During Post-Index Period
timeFrame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Number of Participants Who Used Opioids During Pre-Index Period
timeFrame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Number of Participants Who Used Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) During Pre-Index Period
timeFrame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Number of Participants Who Used Opioids During Post-Index Period
timeFrame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Number of Participants Who Used NSAIDs During Post-Index Period
timeFrame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Mean Number of Pharmacy Claims for Opioids During Pre-Index Period
timeFrame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Mean Number of Pharmacy Claims for Non-Steroidal Anti Inflammatory Drugs (NSAIDs) During Pre-Index Period
timeFrame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Mean Number of Pharmacy Claims for Opioids During Post-Index Period
timeFrame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Mean Number of Pharmacy Claims for Non-Steroidal Anti Inflammatory Drugs (NSAIDs) During Post-Index Period
timeFrame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Mean Number of Days From The Index Date to The First Opioid Claim During Post Index Period
timeFrame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Mean Number of Days From The Index Date to The First NSAIDs Claim During Post Index Period
timeFrame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Number of Participants Who Used Opioids During Tofacitinib Persistency and Post-Persistency
timeFrame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Number of Participants Who Used NSAIDs During Tofacitinib Persistency and Post-Persistency
timeFrame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Number of Participants Who Used Oral Corticosteroids During Pre-Index Period
timeFrame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Number of Participants Who Used Oral Corticosteroids During Post-Index Period
timeFrame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Mean Total Dose of Oral Corticosteroids During Pre-Index Period
timeFrame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Mean Total Dose of Oral Corticosteroid During Post-Index Period
timeFrame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Mean Number of Visits to Rheumatologist During Pre-Index Period
timeFrame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Mean Number of Visits to Rheumatologist During Variable-Length Pre-Index Period
timeFrame: During variable length pre-index period (1 year before the index date up to 5.2 years)
measure: Mean Disease Duration
timeFrame: During variable length pre-index period (1 year before the index date up to 5.2 years)
measure: Mean Out of Pocket Health Care Costs for Healthcare Services During Pre-Index Period
timeFrame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Mean Out of Pocket Health Care Costs for Healthcare Services During Variable Length Pre-Index Period
timeFrame: During variable length pre-index period (1 year before the index date up to 5.2 years)
measure: Number of Participants With Comorbidities of Interest During Pre-Index Period
timeFrame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Number of Participants With Non-persistence to Index Medication (Tofacitinib)
timeFrame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Number of Participants With Post-Persistence Treatment Patterns
timeFrame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Number of Participants Who Switched From Index Medication (Tofacitinib) at Any Time During Post-Index Period
timeFrame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Number of Participants Who Re-started Index Medication (Tofacitinib) at Any Time During Post-Index Period
timeFrame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Mean Medication Possession Ratio (MPR) for Methotrexate (MTX)
timeFrame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Mean Adherence To Methotrexate (MTX)
timeFrame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Number of Participants Who Used Additional NB-DMARD During Post Index Period
timeFrame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Number of Participants Who Met Medication Effectiveness Criteria: Adherence to Index Medication (Tofacitinib)
timeFrame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Number of Participants Who Met Medication Effectiveness Criteria: No Dose Escalation for Index Medication (Tofacitinib)
timeFrame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Number of Participants Who Met Medication Effectiveness Criteria: No Switch From Index Medication (Tofacitinib)
timeFrame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Number of Participants Who Met Medication Effectiveness Criteria: No Addition of NB-DMARD
timeFrame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Number of Participants Who Met Medication Effectiveness Criteria: Criteria for Oral Glucocorticoids
timeFrame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Number of Participants Who Met Medication Effectiveness Criteria: Use of Injectable Glucocorticoids
timeFrame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Number of Participants With All Cause Ambulatory Visits During Pre-Index Period
timeFrame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Number of Participants With All Cause Emergency Department Visits During Pre-Index Period
timeFrame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Number of Participants With All Cause Inpatient Admissions During Pre-Index Period
timeFrame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Number of Participants With RA Related Ambulatory Visits During Pre-Index Period
timeFrame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Number of Participants With RA Related Emergency Department Visits During Pre-Index Period
timeFrame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Number of Participants With RA Related Inpatient Admissions During Pre-Index Period
timeFrame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Number of Participants With All Cause Ambulatory Visits During Post-Index Period
timeFrame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Number of Participants With All Cause Emergency Department Visits During Post-Index Period
timeFrame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Number of Participants With All Cause Inpatient Admissions During Post-Index Period
timeFrame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Number of Participants With RA Related Ambulatory Visits During Post Index Period
timeFrame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Number of Participants With RA Related Emergency Department Visits During Post Index Period
timeFrame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Number of Participants With RA Related Inpatient Admissions During Post Index Period
timeFrame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Mean Total Health Care Cost All Cause During Pre-Index Period
timeFrame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Mean Total Health Care Cost RA Related During Pre-Index Period
timeFrame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Mean Total Health Care Cost Due to All Cause During Post-Index Period
timeFrame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Mean Total Health Care Cost RA Related During Post-Index Period
timeFrame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
measure: Mean Treatment Persistence Duration Measured for Index Medication (Tofacitinib)
timeFrame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years])
Secondary outcomes:
measure: Mean Total All Cause Monthly Health Care Cost
timeFrame: During pre-index period (at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 months before index date) and post index period (at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 month post index date)
measure: Mean Total RA Related Monthly Health Care Cost
timeFrame: During pre-index period (at1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 months before index date) and post index period (at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 month after index date)
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: