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Rheumatoid ArthritisNCT04047121

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

An observational study of Rheumatoid Arthritis, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
How many people
1,349 participants
Where
1 siteUnited States
Study dates
20 May 2019to 21 Oct 2019
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients

Who may be able to join

  • 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

Who cannot join

  • -None

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Pfizer

    Collegeville, Pennsylvania, 19426

Other trials in United States

About this study

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

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.

Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04047121
Study groupRoleWhat they receive
Truven Health MarketScanThe Truven Health MarketScan Research Databases reflects the combined healthcare service use of individuals covered by Truven Health clients (including employers, health plans, and hospitals) nationwide.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: During 12 months post-index date

  2. 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.

    Measured: During 12 months post-index date

  3. 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.

    Measured: During 12 months post-index date

  4. 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.

    Measured: During 12 months post index date

  5. 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.

    Measured: During 12 months post index date

Secondary outcomes (37)
  1. 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.

    Measured: During 12 months post-index date

  2. 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.

    Measured: During 12 months post-index date

  3. 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.

    Measured: During 12 month post-index date

  4. 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.

    Measured: During 12 months post-index date

  5. 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.

    Measured: During 12 months post-index date

  6. 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.

    Measured: During 12 months post-index date

  7. 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.

    Measured: During 12 months post-index date

  8. 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.

    Measured: During 12 months post-index date

  9. 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.

    Measured: During 12 months post-index date

  10. 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.

    Measured: During 12 months post-index date

  11. 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.

    Measured: During 12 months post-index date

  12. 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.

    Measured: During 12 months post-index date

  13. 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.

    Measured: During 12 months post-index date

  14. 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.

    Measured: During 12 months post-index date

  15. 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.

    Measured: During 12 months post-index date

  16. 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.

    Measured: During 12 months post-index date

  17. 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.

    Measured: During 12 months post-index date

  18. 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.

    Measured: During 12 months pre-index date

  19. 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.

    Measured: During 12 months pre-index date

  20. 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.

    Measured: During 12 months pre-index date

  21. 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.

    Measured: During 12 months pre-index date

  22. 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.

    Measured: During 12 months post-index date

  23. 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.

    Measured: During 12 months post-index date

  24. 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.

    Measured: During 12 months post-index date

  25. 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.

    Measured: During 12 months post-index date

  26. 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.

    Measured: During 12 months pre-index date

  27. 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.

    Measured: During 12 months pre-index date

  28. 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.

    Measured: During 12 months pre-index date

  29. 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.

    Measured: During 12 months pre-index date

  30. 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.

    Measured: During 12 months post-index date

  31. 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.

    Measured: During 12 months post-index date

  32. 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.

    Measured: During 12 months post-index date

  33. 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.

    Measured: During 12 months post-index date

  34. 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.

    Measured: During 12 months pre-index date

  35. 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.

    Measured: During 12 months post-index date

  36. 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.

    Measured: During 12 months pre-index date

  37. 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.

    Measured: During 12 months post-index date

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2019
  2. Study start20 May 2019
  3. Primary completion21 Oct 2019
  4. Study completion21 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1,349 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04047121
Sponsor's protocol ID
A3921346
Status last verified
Jun 2023
First submitted
4 Aug 2019
Last updated
9 Jun 2023
Individual data sharing
No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis, run by Pfizer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Were Persistent With Index Medication During 12 Months Post-index Date (time frame: During 12 months post-index date). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2023.

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