A Study to Evaluate Patient Characteristics and Treatment Patterns Among Rheumatoid Arthritis Patients

Rheumatoid Arthritis Clinical Trial

Official title:

Evaluation of Xeljanz Access Barriers Via Patient OOP Costs and TNFi Cycling

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04047121
• Other study ID #: A3921346
• Status: Completed
• Start date: May 20, 2019
• Est. completion date: October 21, 2019

Study information

• Verified date: June 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1349
• Est. completion date: October 21, 2019
• Est. primary completion date: October 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
United States	Pfizer	Collegeville	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Were Persistent With Index Medication During 12 Months Post-index Date	Persistent with the index medication was defined as not having a gap in the therapy of at least 60 days between prescription fill dates and their administration. Index medications were tofacitinib, adalimumab or etanercept.	During 12 months post-index date
Primary	Percentage of Participants Who Immediately Switched Index Medication During 12 Months Post-index Date	Participants who switched from index medication immediately were those who initiated a non-index advanced therapy before end of a 60-day gap in index medication. Index medications were tofacitinib, adalimumab or etanercept.	During 12 months post-index date
Primary	Percentage of Participants Who Discontinued Then Switched Index Medication During 12 Months Post-index Date	Participants who discontinued index medication then switched from index medication were those who had gap in the index medication therapy of at least 60 days and then after the gap they switched to an advanced therapy different from index medication. Index medications were tofacitinib, adalimumab or etanercept.	During 12 months post-index date
Primary	Percentage of Participants Who Discontinued Then Restarted Index Medication During 12 Months Post-index Date	Participants who discontinued index medication and then restarted index medication were those who had a gap in the index medication therapy of at least 60 days and the first advanced therapy observed after the gap was the index medication. Index medications were tofacitinib, adalimumab or etanercept.	During 12 months post index date
Primary	Percentage of Participants Who Discontinued Without Switching or Restarting Index Medication During 12 Months Post-index Date	Participants who discontinued index medication without switching or restarting index medication were those who had a gap in index medication therapy of at least 60 days and there were no claims for either the index medication or a different advanced therapy for the remainder of the follow-up period. Index medications were tofacitinib, adalimumab or etanercept.	During 12 months post index date
Secondary	Percentage of Participants Who Switched Index Medication Any Time During 12 Months Post-index Date	Participants who switched from index medication at any time during the 12-month follow-up post-index period were evaluated. Index medications were tofacitinib, adalimumab or etanercept.	During 12 months post-index date
Secondary	Mean of Number of Days to Immediate Switch From Index Medication During 12 Months Post-index Date	Participants who switched from index medication immediately were those who initiated a non-index advanced therapy before the end of a 60-day gap in index medication. Index medications were tofacitinib, adalimumab or etanercept. Number of days to immediately switch from index medication = immediate switch date - index date + 1.	During 12 months post-index date
Secondary	Mean of Number of Days to Immediate or Delayed Switch Index Medication During 12 Months Post-index Date	Number of days to immediate or delayed switch from index medication any time during the 12-month follow-up period = immediate or delayed switch date - index date + 1. Index medications were tofacitinib, adalimumab or etanercept.	During 12 month post-index date
Secondary	Mean of Number of Days to Discontinue Index Medication During 12 Months Post-index Date	Number of days to discontinue index medication = date of last persistent index medication prescription/administration + days supply- index date + 1. Index medications were tofacitinib, adalimumab or etanercept. Persistent with the index medication was defined as not having a gap in the therapy of at least 60 days between prescription fill dates and their administration.	During 12 months post-index date
Secondary	Duration of Index Medication Persistent Therapy During 12 Months Post-index Date	Index medication persistent therapy duration was defined as days to discontinue or immediate switch or end of 12 months post-index follow if participants remained persistent, whichever came first. Index medications were tofacitinib, adalimumab or etanercept. Persistent with the index medication: not having a gap in the therapy of at least 60 days between prescription fill dates and their administration. Discontinuation from index medication: gap in the index medication therapy of at least 60 days. Immediate switch from index medication: initiation of a non-index advanced therapy before end of a 60-day gap in index medication.	During 12 months post-index date
Secondary	Percentage of Participants Who Were Persistent With Main Non-Biologic Disease Modifying Antirheumatic Drugs (NB-DMARD) During 12 Months Post-index Date: Combination Therapy	Participants who initiated index medication in combination with main NB-DMARDSs were analyzed to evaluate percentage of participants who were persistent with main NB-DMARDs use. Main NB-DMARDs considered in the study were methotrexate, sulfasalazine, leflunomide, and hydroxychloroquine. Index medications were tofacitinib, adalimumab or etanercept. Persistence with main NB-DMARDs was defined as not having a gap of at least 60 days between prescription fill dates and their administration.	During 12 months post-index date
Secondary	Percentage of Participants Who Immediately Switched From Main NB-DMARDs During 12 Months Post-index Date: Combination Therapy	Participants who initiated index medication in combination with main NB-DMARDSs were analyzed to evaluate percentage of participants who immediately switched from main NB-DMARDs. Main NB-DMARDS considered in the study were methotrexate, sulfasalazine, leflunomide, and hydroxychloroquine. Index medications were tofacitinib, adalimumab or etanercept. Immediate switch from main NB-DMARDs was defined as initiation of other medication than main NB-DMARDs, before end of a 60-day gap.	During 12 months post-index date
Secondary	Percentage of Participants Who Discontinued Then Switched From Main NB-DMARDs During 12 Months Post-index Date: Combination Therapy	Participants who initiated index medication in combination with main NB-DMARDSs were analyzed to evaluate percentage of participants who discontinued then switched from main NB-DMARDs. Main NB-DMARDS considered in the study were methotrexate, sulfasalazine, leflunomide, and hydroxychloroquine. Index medications were tofacitinib, adalimumab or etanercept. Participants who discontinued main NB-DMARDs then switched from main NB-DMARDS were those who had gap in the main NB-DMARDs medication of at least 60 days and then after the gap switched to other medication than main NB-DMARDs.	During 12 months post-index date
Secondary	Percentage of Participants Who Discontinued Then Restarted Main NB-DMARDs During 12 Months Post-index Date: Combination Therapy	Participants who initiated index medication in combination with main NB-DMARDSs were analyzed to evaluate percentage of participants who discontinued then restarted main NB-DMARDs. Main NB-DMARDS considered in the study were methotrexate, sulfasalazine, leflunomide, and hydroxychloroquine. Index medications were tofacitinib, adalimumab or etanercept. Participants who discontinued main NB-DMARDs and then restarted main NB-DMARDs were those who had a gap in main NB-DMARDs of at least 60 days and after the gap, they started main NB-DMARDs again.	During 12 months post-index date
Secondary	Percentage of Participants Who Discontinued Without Switching or Restarting Main NB-DMARDs During 12 Months Post-index Date: Combination Therapy	Participants who initiated index medication in combination with main NB-DMARDSs were analyzed to evaluate percentage of participants who discontinued without switching or restarting main NB-DMARDs. Main NB-DMARDS considered in the study were methotrexate, sulfasalazine, leflunomide, and hydroxychloroquine. Index medications were tofacitinib, adalimumab or etanercept. Participants who discontinued main NB-DMARDs without switching or restarting main NB-DMARDs were those who had a gap in main NB-DMARDs of at least 60 days and there were no claims for either the main NB-DMARDs or a different therapy for the remainder of the follow-up period.	During 12 months post-index date
Secondary	Percentage of Participants Who Initiated Index Medication as Monotherapy and Eventually Added NB-DMARDs During 12 Months Post-index Date	Percentage of participants who initiated only index medication and then eventually also added any NB-DMARDs, 1 of the 4 mains NB-DMARDs or other than these 4 NB-DMARDs in their therapy, were evaluated. Main NB-DMARDS considered in the study were methotrexate, sulfasalazine, leflunomide, and hydroxychloroquine. Any NB-DMARDs included those participants who received any of the NB-DMARDs and participant was counted only once if took different NB-DMARDs during the follow-up period. Participants might be counted more than once in categories except category "Any NB-DMARDs". Index medications were tofacitinib, adalimumab or etanercept.	During 12 months post-index date
Secondary	Percentage of Participants Who Met Adherence Effectiveness Criteria During 12 Months Post-index Date	A proportion of days covered (PDC) was calculated based on total days' supply over the 12 months post-index. The PDC was calculated by using the date of service and the day supply for each fill of the index medication. Participants with early refills were allowed to stockpile medications up to a maximum of 14 days total for later use. Participants who met adherence effective criteria were those who had PDC >=0.8. Index medications were tofacitinib, adalimumab or etanercept.	During 12 months post-index date
Secondary	Percentage of Participants Who Met Dose Escalation Effectiveness Criteria During 12 Months Post-index Date	Dose escalation for index medication was defined as: 1) for adalimumab: at least 1 claim in the 12 months post-index follow-up with an average weekly dose of at least 40 milligram per week (mg/week), 2) for etanercept: at least 1 claim in the 12 months post-index follow-up with an average weekly dose of at least 100 mg/week, 3) for tofacitinib: at least 1 claim in the 12 months post-index follow-up with an average weekly dose of at least 20 milligram per day (mg/day) for immediate release and 22 mg/day for extended release. Participants who met dose escalation effectiveness criteria were those who did not have any dose escalation for index medication compared to the starting dose.	During 12 months post-index date
Secondary	Percentage of Participants Who Met Switched Effectiveness Criteria During 12 Months Post-index Date	A switch for this outcome measure was defined as use of a different biologic disease modifying antirheumatic drug (B-DMARDs) or Janus kinase inhibitor (JAKi), any time during the 12 months post-index follow-up. Participants who met switched effectiveness criteria were those who did not switch from the index medication to B-DMARDs or JAKi. Index medications were tofacitinib, adalimumab or etanercept.	During 12 months post-index date
Secondary	Percentage of Participants Who Met NB-DMARD Effectiveness Criteria During 12 Months Post-index Date	Participants who started only index medication regimen (as monotherapy), but eventually initiated main NB-DMARDs were identified in the 12 months post-index follow-up period as adding new NB-DMARD. Participants who started index medication regimen along with any of the main NB-DMARDs (combination therapy), presence of a different NB-DMARD in 12 months post-index was identified as adding new NB-DMARD. Participants who met NB-DMARD effectiveness criteria were those who did not add a new NB-DMARD in the 12 months post-index follow up. Index medications were tofacitinib, adalimumab or etanercept.	During 12 months post-index date
Secondary	Percentage of Participants Who Met Oral Glucocorticoid Effectiveness Criteria During 12 Months Post-index Date	Oral glucocorticoid effectiveness criteria for participants with no claims for oral glucocorticoid prescriptions in the 6 months prior to the index date = did not receive more than 30 days of oral glucocorticoids between (index date + 89 days) to (index date + 359 days). 30 days of oral glucocorticoids was determined by summing up the day supply of all glucocorticoids claims with a fill date between (index date + 89 days) to (index date + 359 days). Oral glucocorticoid effectiveness criteria for participants with claims for oral glucocorticoids during the 6 months prior to the index date = no increase in oral glucocorticoid dose >=20% during months 6-12 after index compared to the 6 months before the index date. Increase in oral glucocorticoids was determined from the prednisone equivalent dose for all glucocorticoid claims filled.	During 12 months post-index date
Secondary	Percentage of Participants Who Met Infusion Glucocorticoid Effectiveness Criteria During 12 Months Post-index Date	Glucocorticoid infusion effectiveness criteria was receiving of maximum of 1 parenteral or intra-articular glucocorticoid joint injection on unique days (between [index date + 89 days] to [index date + 359 days]) after the participants had been on treatment with index medication for more than 3 months. Index medications were tofacitinib, adalimumab or etanercept.	During 12 months post-index date
Secondary	Mean of Rheumatoid Arthritis (RA) Related Inpatient Visits During 12 Months Pre-index Date	Inpatient visits refers when participants visited hospital for formal admission. In this outcome measure, mean of number of inpatient visits related to RA during 12 months pre-index were evaluated.	During 12 months pre-index date
Secondary	Mean of Rheumatoid Arthritis Related Emergency Department (ED) Visits During 12 Months Pre-Index Date	In this outcome measure, mean of number of emergency department visits related to RA during 12 months pre-index were evaluated.	During 12 months pre-index date
Secondary	Mean of Rheumatoid Arthritis Related Outpatient Visits During 12 Months Pre-index Date	Outpatient visits refers when participants visited hospital but not for formal admission. In this outcome measure, mean of number of outpatient visits related to RA during 12 months pre-index were evaluated.	During 12 months pre-index date
Secondary	Mean of Rheumatoid Arthritis-Related Pharmacy Visits During 12 Months Pre-index Date	In this outcome measure, mean of number of pharmacy visits related to RA during 12 months pre-index were evaluated.	During 12 months pre-index date
Secondary	Mean of Rheumatoid Arthritis Related Inpatient Visits During 12 Months Post-index Date	Inpatient visits refers when participants visited hospital for formal admission. In this outcome measure, mean of number of inpatient visits related to RA during 12 months post-index were evaluated.	During 12 months post-index date
Secondary	Mean of Rheumatoid Arthritis Related Emergency Department (ED) Visits During 12 Months Post-index Date	In this outcome measure, mean of number of emergency department visits related to RA during 12 months post-index were evaluated.	During 12 months post-index date
Secondary	Mean of Rheumatoid Arthritis Related Outpatient Visits During 12 Months Post-index Date	Outpatient visits refers when participants visited hospital but not for formal admission. In this outcome measure, mean of number of outpatient visits related to RA during 12 months post-index were evaluated.	During 12 months post-index date
Secondary	Mean of Rheumatoid Arthritis Related Pharmacy Visits During 12 Months Post-index Date	In this outcome measure, mean of number of pharmacy visits related to RA during 12 months post-index were evaluated.	During 12 months post-index date
Secondary	Mean of All Cause Inpatient Visits During 12 Months Pre-Index Date	Inpatient visits refers when participants visited hospital for formal admission. In this outcome measure, mean of number of inpatient visits regardless of reason (including related to RA) during 12 months pre-index were evaluated.	During 12 months pre-index date
Secondary	Mean of All Cause Emergency Department (ED) Visits During 12 Months Pre-index Date	In this outcome measure, mean of number of emergency department visits regardless of reason (including related to RA) during 12 months pre-index were evaluated.	During 12 months pre-index date
Secondary	Mean of All Cause Outpatient Visits During 12 Months Pre-Index Date	Outpatient visits refers when participants visited hospital but not for formal admission. In this outcome measure, mean of number of outpatient visits regardless of reason (including related to RA) during 12 months pre-index were evaluated.	During 12 months pre-index date
Secondary	Mean of All Cause Pharmacy Visits During 12 Months Pre-index Date	In this outcome measure, mean of number of pharmacy visits regardless of reason (including related to RA) during 12 months pre-index were evaluated.	During 12 months pre-index date
Secondary	Mean of All Cause Inpatient Visits During 12 Months Post-index Date	Inpatient visits refers when participants visited hospital for formal admission. In this outcome measure, mean of number of inpatient visits regardless of reason (including related to RA) during 12 months post-index were evaluated.	During 12 months post-index date
Secondary	Mean of All Cause Emergency Department (ED) Visits During 12 Months Post-index Date	In this outcome measure, mean of number of emergency department visits regardless of reason (including related to RA) during 12 months post-index were evaluated.	During 12 months post-index date
Secondary	Mean of All Cause Outpatient Visits During 12 Months Post-index Date	Outpatient visits refers when participants visited hospital but not for formal admission. In this outcome measure, mean of number of outpatient visits regardless of reason (including related to RA) during 12 months post-index were evaluated.	During 12 months post-index date
Secondary	Mean of All Cause Pharmacy Visits During 12 Months Post-index Date	In this outcome measure, mean of number of pharmacy visits regardless of reason (including related to RA) during 12 months post-index were evaluated.	During 12 months post-index date
Secondary	Mean of Rheumatoid Arthritis Related Total Health Care Cost During 12 Months Pre-index Date	Total health care cost related to RA was calculated as sum of medical (outpatient, inpatient and emergency visit) cost and treatment costs (pharmacy cost) related to rheumatoid arthritis.	During 12 months pre-index date
Secondary	Mean of Rheumatoid Arthritis Related Total Health Care Cost During 12 Months Post-index Date	Total health care cost related to RA was calculated as sum of medical (outpatient, inpatient and emergency visit) cost and treatment costs (pharmacy cost) related to rheumatoid arthritis.	During 12 months post-index date
Secondary	All Cause Total Health Care Cost During 12 Months Pre-index Date	All cause total health care cost was calculated as sum of medical (outpatient, inpatient and emergency visit) cost and treatment cost (pharmacy cost) regardless of reason including RA.	During 12 months pre-index date
Secondary	All Cause Total Health Care Cost During 12 Months Post-index Date	All cause total health care cost was calculated as sum of medical (outpatient, inpatient and emergency visit) cost and treatment cost (pharmacy cost) regardless of reason including RA.	During 12 months post-index date

External Links

•   To obtain contact information for a study center near you, click here.