- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03964649
Comparative Analysis of Outcomes Among Patients Treated With Xeljanz vs Biologics
May 12, 2021 updated by: Pfizer
Comparative Analysis of Outcomes Among Rheumatoid Arthritis Patients Treated With Xeljanz Versus Biologic DMARDs Using a United States Healthcare Claims Database
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
7308
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10017
- Pfizer
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 second and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
This study will utilize the de-identified claims data in the Truven Health MarketScan Research Database.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
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Truven Health MarketScan Research Database
To compare RA-related costs among patients treated with tofacitinib (IR, XR and combined groups) to patients treated with each of the bDMARDs (individually, as well as to TNFi and to non-TNFi each combined as groups).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants Who Were on Combination Therapy and Monotherapy During 90 Days After Index Date
Time Frame: 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)
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In this outcome measure number of participants who were on combination therapy with index medication and who were on monotherapy during 12 months pre-index date were reported.
Participants with a use of at least 1 of 4 specific csDMARDs (methotrexate, sulfasalazine, hydroxychloroquine, leflunomide) within 90 days on or after the index date were considered as being treated with combination therapy.
Participants who did not take any csDMARDs along with index medication were considered being treated with monotherapy.
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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)
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Number of Participants for Each of the Most Commonly Used Medications During the 12 Months Post-index Date
Time Frame: 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)
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Number of participants with most commonly used medications use during 12 months post index period are reported.
The 25 most medications: 1) methotrexate sodium, 2) prednisone, 3) folic acid, 4) adalimumab, 5) etanercept, 6) acetaminophen/hydrocodone bitartrate, 7) hydroxychloroquine sulfate, 8) azithromycin, 9) levothyroxine sodium, 10) tramadol hydrochloride, 11) methylprednisolone, 12) gabapentin, 13) albuterol sulfate, 14) amoxicillin/clavulanate potassium, 15) omeprazole, 16) amoxicillin, 17) meloxicam, 18) tofacitinib citrate, 19) fluticasone propionate, 20) cyclobenzaprine hydrochloride, 21) diclofenac sodium, 22) duloxetine hydrochloride, 23) atorvastatin calcium, 24) leflunomide, 25) fluconazole.
A participant could have received >=1 most common medication.
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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)
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Number of Participants Who Used Opioids and Non-steroidal Anti-inflammatory Drug (NSAIDs) During 12 Months Post Index Period
Time Frame: 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)
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Number of participants who used at least 1 opioid and NSAID during post-index period are reported.
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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)
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Mean Number of Pharmacy Claims for Opioids and NSAIDS During 12 Months Post Index Period
Time Frame: 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)
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The mean number of pharmacy claims for opioids and NSAIDs during the post-index period are reported.
A pharmacy claim was defined as a claim made by participants to their insurance provider in purchasing opioids and NSAIDs from the pharmacy.
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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)
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Mean Number of Days From The Index Date to the First Opioid and NSAIDs Claim During 12 Months Post Index Period
Time Frame: 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)
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Mean number of days from the index date to the first opioid and NSAIDs claim during post index period are reported.
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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)
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Number of Participants Who Used Opioids and NSAIDs While Persistent and After Persistent With Index Medication During 12 Months Post Index Period
Time Frame: 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)
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Number of participants who used opioids and NSAIDs during tofacitinib persistency and post-persistency are reported.
Persistence with the index medication was defined as not having a gap in therapy of at least 60 days between fills/infusions.
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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)
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Number of Participants Who Used Oral Corticosteroids During 12 Months Post-Index Period
Time Frame: 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)
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The number of participants who used at least 1 oral corticosteroid during the 12 months post-index period are reported.
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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)
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Number of Participants Who Were Non-persistent to Index Medication
Time Frame: 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)
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Non-persistence was defined as the gap of at least 60 days in treatment with the index medication or switching to other biologic.
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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)
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Number of Participants Who Switched Immediately From Index Medication
Time Frame: 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)
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Participants were classified as switched immediately if they initiated a non-index bDMARD before a 60-day gap in index medication treatment.
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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)
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Number of Participants Who Discontinued Then Restarted Index Medication
Time Frame: 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)
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Participants were classified as discontinued and then restarted index medication if there was a gap in the index therapy of at least 60 days and the first medication observed after the gap was the index medication.
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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)
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Number of Participants Who Discontinued Then Switched From Index Medication
Time Frame: 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)
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Participants were classified as discontinued and then switched from index medication if there was a gap in the index therapy of at least 60 days and the first medication observed after the gap was a bDMARD (including tofacitinib) different from index medication.
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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)
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Number of Participants Who Discontinued Without Switching or Restarting Index Medication
Time Frame: 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)
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Participants were classified as discontinued without switching or restarting index medication if they had a gap in therapy of at least 60 days and there were no claims for either the index medication or a different bDMARD for the remainder of the follow-up period.
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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)
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Number of Participants Who Switched Any Time From Index Medication
Time Frame: 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)
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Number of participants who switched from index medication to a biologic at any time during post-index period are reported.
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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)
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Number of Participants Who Re-started Index Medication at Any Time
Time Frame: 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)
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Participants who had a claim for the index medication any time after they were considered non-persistent with the index treatment (i.e, including after switching) during the 12-month follow-up are reported.
Non-persistence was defined as the gap of at least 60 days in treatment with the index medication or switching to other biologic.
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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)
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Mean Medication Possession Ratio (MPR) for Methotrexate
Time Frame: 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)
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MPR was calculated as the total days supply of methotrexate between the first and including the last prescription/administration divided by the time between the first through and including last biologic prescription/administration days supply.
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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)
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Proportion of Days Covered (PDC)
Time Frame: 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)
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The PDC was calculated based on total days supply over the 12 months follow-up.
The PDC was calculated by using the date of service and the day supply for each fill of the index medication.
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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)
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Addition of Conventional Synthetic Disease-modifying Antirheumatic Drug (Cs-DMARDs) in Participants With Monotherapy
Time Frame: 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)
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Participants with monotherapy who used additional csDMARD during post index period are reported.
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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)
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Adherence to Cs-DMARDs in Participants With Combination Therapy
Time Frame: 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)
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Adherence was calculated as the total day supply for csDMARDs divided by the number of days from the first claim during the follow-up until the end of the follow-up.
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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)
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Number of Participants Who Met Different Medication Effectiveness Criteria
Time Frame: 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)
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Adherence criteria: PDC >=0.8, proportion of days of supply during post-index period of 12 months.Dose escalation criteria: no increase in dose for index drug compared to starting dose during post-index period.
Switch criteria: no switching from index drug to (different) biologic agent during post-index period.
DMARD criteria: no addition of new csDMARD to index drug during post-index period.
Oral glucocorticoid criteria: Participants with no claims for oral glucocorticoids in 6 months pre-index cannot receive oral glucocorticoids for greater than (>)30 days between (index date +91 days) to (index date + 365 days); or participants with claims for oral glucocorticoids in 6 months pre-index no increase in oral glucocorticoid dose during months 6-12 post-index.Injectable glucocorticoid criteria: at most 1 parenteral or intra-articular glucocorticoid joint injection on unique days after participant had been on bDMARD treatment for >3 months between (index date + 91) to (index date + 365).
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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)
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All Cause Inpatient Visits Costs, Outpatient Visits Costs and Emergency Room (ER) Visits Costs During 12 Months Post Index Period
Time Frame: 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)
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All cause inpatient visits costs, outpatient visits costs and emergency room visits costs during 12 months post index period are reported.
Inpatient visit costs consisted of expenses during hospital visit for formal admission.
Outpatient visit costs consisted of expenses when participants visited hospital but not for formal admission.
Emergency room visit costs consisted of expenses during visit to hospital emergency room.
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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)
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Rheumatoid Arthritis (RA) Related Inpatient Visits Costs, Outpatient Visits Costs and Emergency Room (ER) Visits Costs During 12 Months Post Index Period
Time Frame: 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)
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RA related inpatient visit costs consisted of expenses during hospital visits for formal admission for RA.
Outpatient visit costs consisted of expenses when participants visited hospital but not for formal admission for RA.
ER visit costs consisted of expenses during visit to ER of hospital for RA.
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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)
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All Cause Total Health Care Costs, Medical Costs, Pharmacy Costs During 12 Months Post-Index Period
Time Frame: 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)
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All cause total health care costs, medical costs, pharmacy costs during 12 months post-index period are reported.
All cause refers to cost spent due to all comorbidities including RA.
Total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs).
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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)
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RA Related Total Health Care Costs, Medical Costs, Pharmacy Costs During 12 Months Post-Index Period
Time Frame: 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)
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RA related total health care costs, medical costs, pharmacy costs during 12 months post-index period are reported.
RA related total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs).
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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)
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Total All Cause Monthly Health Care Cost at Month 1 Post Index Date
Time Frame: Month 1 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
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All cause refers to cost spent due to all comorbidities including RA.
Total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs).
In this outcome measure total all cause health care cost in dollars is reported for Month 1 post-index date.
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Month 1 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
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Total All Cause Monthly Health Care Cost at Month 2 Post Index Date
Time Frame: Month 2 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
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All cause refers to cost spent due to all comorbidities including RA.
Total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs).
In this outcome measure total all cause health care cost in dollars is reported for Month 2 post-index date.
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Month 2 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
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Total All Cause Monthly Health Care Cost at Month 3 Post Index Date
Time Frame: Month 3 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
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All cause refers to cost spent due to all comorbidities including RA.
Total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs).
In this outcome measure total all cause health care cost in dollars is reported for Month 3 post-index date.
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Month 3 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
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Total All Cause Monthly Health Care Cost at Month 4 Post Index Date
Time Frame: Month 4 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
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All cause refers to cost spent due to all comorbidities including RA.
Total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs).
In this outcome measure total all cause health care cost in dollars is reported for Month 4 of post-index date.
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Month 4 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
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Total All Cause Monthly Health Care Cost at Month 5 Post Index Date
Time Frame: Month 5 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
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All cause refers to cost spent due to all comorbidities including RA.
Total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs).
In this outcome measure total all cause health care cost in dollars is reported for Month 5 post-index date.
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Month 5 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
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Total All Cause Monthly Health Care Cost at Month 6 Post Index Date
Time Frame: Month 6 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
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All cause refers to cost spent due to all comorbidities including RA.
Total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs).
In this outcome measure total all cause health care cost in dollars is reported for Month 6 post-index date.
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Month 6 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
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Total All Cause Monthly Health Care Cost at Month 7 Post Index Date
Time Frame: Month 7 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
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All cause refers to cost spent due to all comorbidities including RA.
Total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs).
In this outcome measure total all cause health care cost in dollars is reported for Month 7 post-index date.
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Month 7 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
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Total All Cause Monthly Health Care Cost at Month 8 Post Index Date
Time Frame: Month 8 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
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All cause refers to cost spent due to all comorbidities including RA.
Total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs).
In this outcome measure total all cause health care cost in dollars is reported for Month 8 post-index date.
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Month 8 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
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Total All Cause Monthly Health Care Cost at Month 9 Post Index Date
Time Frame: Month 9 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
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All cause refers to cost spent due to all comorbidities including RA.
Total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs).
In this outcome measure total all cause health care cost in dollars is reported for Month 9 post-index date.
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Month 9 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
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Total All Cause Monthly Health Care Cost at Month 10 Post Index Date
Time Frame: Month 10 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
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All cause refers to cost spent due to all comorbidities including RA.
Total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs).
In this outcome measure total all cause health care cost in dollars is reported for Month 10 post-index date.
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Month 10 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
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Total All Cause Monthly Health Care Cost at Month 11 Post-index Date
Time Frame: Month 11 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
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All cause refers to cost spent due to all comorbidities including RA.
Total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs).
In this outcome measure total all cause health care cost in dollars is reported for Month 11 post-index date.
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Month 11 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
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Total All Cause Monthly Health Care Cost at Month 12 Post Index Date
Time Frame: Month 12 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
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All cause refers to cost spent due to all comorbidities including RA.
Total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs).
In this outcome measure total all cause health care cost in dollars is reported for Month 12 post-index date.
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Month 12 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
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Total RA Related Monthly Health Care Cost at Month 1 Post Index Date
Time Frame: Month 1 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
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RA related total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs).
In this outcome measure RA related total all cause health care cost in dollars is reported for Month 1 post-index date.
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Month 1 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
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Total RA Related Monthly Health Care Cost at Month 2 Post Index Date
Time Frame: Month 2 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
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RA related total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs).
In this outcome measurec RA related total all cause health care cost in dollars is reported for Month 2 post-index date.
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Month 2 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
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Total RA Related Monthly Health Care Cost at Month 3 Post Index Date
Time Frame: Month 3 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
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RA related total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs).
In this outcome measure RA related total all cause health care cost in dollars is reported for Month 3 post-index date.
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Month 3 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
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Total RA Related Monthly Health Care Cost at Month 4 Post Index Date
Time Frame: Month 4 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
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RA related total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs).
In this outcome measure RA related total all cause health care cost in dollars is reported for Month 4 post-index date.
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Month 4 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
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Total RA Related Monthly Health Care Cost at Month 5 Post Index Date
Time Frame: Month 5 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
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RA related total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs).
In this outcome measure RA related total all cause health care cost in dollars is reported for Month 5 post-index date.
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Month 5 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
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Total RA Related Monthly Health Care Cost at Month 6 Post Index Date
Time Frame: Month 6 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
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RA related total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs).
In this outcome measure RA related total all cause health care cost in dollars is reported for Month 6 post-index date.
|
Month 6 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
|
Total RA Related Monthly Health Care Cost at Month 7 Post Index Date
Time Frame: Month 7 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
|
RA related total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs).
In this outcome measure RA related total all cause health care cost in dollars is reported for Month 7 post-index date.
|
Month 7 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
|
Total RA Related Monthly Health Care Cost at Month 8 Post Index Date
Time Frame: Month 8 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
|
RA related total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs).
In this outcome measure RA related total all cause health care cost in dollars is reported for Month 8 post-index date.
|
Month 8 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
|
Total RA Related Monthly Health Care Cost at Month 9 Post Index Date
Time Frame: Month 9 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
|
RA related total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs).
In this outcome measure RA related total all cause health care cost in dollars is reported for Month 9 post-index date.
|
Month 9 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
|
Total RA Related Monthly Health Care Cost at Month 10 Post Index Date
Time Frame: Month 10 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
|
RA related total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs).
In this outcome measure RA related total all cause health care cost in dollars is reported for Month 10 post-index date.
|
Month 10 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
|
Total RA Related Monthly Health Care Cost at Month 11 Post-index Date
Time Frame: Month 11 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
|
RA related total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs).
In this outcome measure RA related total all cause health care cost in dollars is reported for Month 11 post-index date.
|
Month 11 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
|
Total RA Related Monthly Health Care Cost at Month 12 Post Index Date
Time Frame: Month 12 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
|
RA related total health care cost was calculated as the total of pharmacy cost (home healthcare cost, urgent care cost and other medical services costs) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost and other costs).
In this outcome measure RA related total all cause health care cost in dollars is reported for Month 12 post-index date.
|
Month 12 post-index date (index date =date of first claim for index medication [bDMARDs or tofacitinib] during identification period of 3.5 years)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2019
Primary Completion (Actual)
April 6, 2020
Study Completion (Actual)
April 6, 2020
Study Registration Dates
First Submitted
May 20, 2019
First Submitted That Met QC Criteria
May 24, 2019
First Posted (Actual)
May 28, 2019
Study Record Updates
Last Update Posted (Actual)
June 2, 2021
Last Update Submitted That Met QC Criteria
May 12, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A3921305
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
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.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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