Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03975790
Previous Study | Return to List | Next Study

Comparative Analysis of Outcomes Among Patients Initiating Xeljanz in Combination With Oral MTX Who Withdraw MTX Versus Continue MTX

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03975790
Recruitment Status : Completed
First Posted : June 5, 2019
Results First Posted : October 22, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date May 29, 2019
First Posted Date June 5, 2019
Results First Submitted Date September 28, 2019
Results First Posted Date October 22, 2019
Last Update Posted Date October 22, 2019
Actual Study Start Date May 29, 2018
Actual Primary Completion Date October 2, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 28, 2019)
  • Number of Participants as Per Type of Insurance Plan [ Time Frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Number of participants covered by type of insurance is reported. There were two types of insurance: 1) a private insurance plan, that is, one purchased by the participants, commercially available; 2) employer-provided insurance plan, that is, the participant's employer provided the insurance.
  • Number of Participants in Each Geographic Region [ Time Frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Number of participants enrolled in the study per geographic region of the United States (northeast; north central; south; west; unknown) is reported.
  • Number of Participants With Biologic Disease Modifying Antirheumatic Drug (bDMARD) Use During Pre-Index Period [ Time Frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Number of Participants with use of at least one bDMARD during pre-index period is reported. The bDMARD could have been any tumor-necrosis factor-alpha inhibitors (TNFi), any non-TNFi, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, anakinra, abatacept, tocilizumab or rituximab.
  • Number of Participants With Biologic Disease Modifying Antirheumatic Drug (bDMARD) Use During Variable Length Pre-Index Period [ Time Frame: During variable length pre-index period (1 year before the index date up to 5.2 years) ]
    Number of Participants with use of at least one bDMARD during variable length pre-index period is reported. The bDMARD could have been any TNFi, any non-TNFi, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, anakinra, abatacept, tocilizumab or rituximab. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant, could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.
  • Mean Number of Biologic Disease Modifying Antirheumatic Drug (bDMARD) Received During Pre-Index Period [ Time Frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Mean number of bDMARD received during pre-index period is reported. The bDMARD could have been any TNFi, any non-TNFi, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, anakinra, abatacept, tocilizumab or rituximab.
  • Mean Number of Biologic Disease Modifying Antirheumatic Drug (bDMARD) Received During Variable Length Pre-Index Period [ Time Frame: During variable length pre-index period (1 year before the index date up to 5.2 years) ]
    Mean number of bDMARD received during variable length pre-index period is reported. The bDMARD could have been any TNFi, any non-TNFi, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, anakinra, abatacept, tocilizumab or rituximab. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.
  • Number of Participants With Non-biologic Disease Modifying Antirheumatic Drug (NB-DMARD) Use During Pre-Index Period [ Time Frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Number of Participants with NB-DMARD use during pre-index period is reported. The NB-DMARD could have been hydroxychloroquine, MTX oral, leflunomide, sulfasalazine, chloroquine, cyclosporine, thalidomide, azathioprine, cyclophosphamide, auranofin, aurothioglucose, gold sodium thiomalate, penicillamine, tacrolimus or minocycline.
  • Number of Participants With Non-Biologic Disease Modifying Antirheumatic Drug (NB-DMARD) Use During Variable Length Pre-Index Period [ Time Frame: During variable length pre-index period (1 year before the index date up to 5.2 years) ]
    Number of Participants with NB-MARD use during variable length pre-index period is reported. The NB-DMARD could have been hydroxychloroquine, MTX oral, leflunomide, sulfasalazine, chloroquine, cyclosporine, thalidomide, azathioprine, cyclophosphamide, auranofin, aurothioglucose, gold sodium thiomalate, penicillamine, tacrolimus or minocycline. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.
  • Mean Number of Non-Biologic Disease Modifying Antirheumatic Drug (NB-DMARD) Received During Pre-Index Period [ Time Frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Mean number of NB-DMARD received during pre-index period is reported. The NB-DMARD could have been hydroxychloroquine, MTX oral, leflunomide, sulfasalazine, chloroquine, cyclosporine, thalidomide, azathioprine, cyclophosphamide, auranofin, aurothioglucose, gold sodium thiomalate, penicillamine, tacrolimus or minocycline.
  • Mean Number of Non-Biologic Disease Modifying Antirheumatic Drug (NB-DMARD) Received During Variable Length Pre-Index Period [ Time Frame: During variable length pre-index period (1 year before the index date up to 5.2 years) ]
    Mean number of NB-DMARD received during variable length pre-index period is reported. The NB-DMARD could have been hydroxychloroquine, MTX oral, leflunomide, sulfasalazine, chloroquine, cyclosporine, thalidomide, azathioprine, cyclophosphamide, auranofin, aurothioglucose, gold sodium thiomalate, penicillamine, tacrolimus or minocycline. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.
  • Mean Quan-Charlson Comorbidity Score of Participants [ Time Frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    The mean Quan-Charlson Comorbidity Score during the Pre-Index Period is reported. Quan-Charlson Comorbidity Score predicts the probability of death within one year in participants and was based on the presence of any diagnosis codes on medical claims at any time during the 12-month pre-index period, based on the International Classification of Diseases (ICD) diagnosis codes. Total score ranges from 0 to 9.0. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome could result in mortality or higher healthcare resource utilization.
  • Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Pre-Index Period [ Time Frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Top 25 comorbid conditions: 1) rheumatoid arthritis/related disease, 2)other aftercare, 3)other connective tissue disease, 4)other non-traumatic joint disorders, 5)medical examination/evaluation, 6) other suspected conditions(other miscellaneous conditions other than mental disorders/infectious disease), 7)immunizations/screening for infectious disease, 8)osteoarthritis, 9)essential hypertension, 10) residual codes: unclassified, 11)disorders of lipid metabolism, 12)back problems, 13)other upper respiratory infections, 14)other lower respiratory disease, 15)other nervous system disorders, 16)other skin disorders, 17)thyroid disorders, 18)other bone disease/musculoskeletal deformities, 19) malaise/fatigue, 20)esophageal disorders, 21)nutritional deficiencies, 22)other nutritional: endocrine, metabolic disorders, 23)diabetes mellitus without complication, 24)other/unspecified benign neoplasm, 25)genitourinary symptoms/ill-defined conditions. A participant could have had >=1 comorbidity.
  • Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Post-Index Period [ Time Frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Top 25 comorbid conditions: 1) rheumatoid arthritis/related disease, 2)other aftercare, 3)other connective tissue disease, 4)other non-traumatic joint disorders, 5)medical examination/evaluation, 6) other suspected conditions(other miscellaneous conditions other than mental disorders/infectious disease), 7)immunizations/screening for infectious disease, 8)osteoarthritis, 9)essential hypertension, 10) residual codes: unclassified, 11)disorders of lipid metabolism, 12)back problems, 13)other upper respiratory infections, 14)other lower respiratory disease, 15)other nervous system disorders, 16)other skin disorders, 17)thyroid disorders, 18)other bone disease/musculoskeletal deformities, 19) malaise/fatigue, 20)esophageal disorders, 21)nutritional deficiencies, 22)other nutritional: endocrine, metabolic disorders, 23)diabetes mellitus without complication, 24)other/unspecified benign neoplasm, 25)Other upper respiratory disease. A participant could have had >=1 comorbidity.
  • Mean Claims Based Index of RA Severity (CIRAS) Score During Pre-Index Period [ Time Frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    The mean of the CIRAS score during pre-index period is reported. The CIRAS is based on claims at any time during the 12-month pre-index period, used to measure RA disease severity using 9 measures (age at index, gender, inflammatory marker test ordered, rehabilitation visit, rheumatoid factor test, Felty's syndrome, number of platelet counts ordered, number of chemistry panels ordered, rheumatologist visit). Value of all 9 measure was used to derive the overall CIRAS score which ranges from 0-7.9 with higher value indicating greater severity of RA.
  • Number of Participants With 25 Most Common Medications Use During Pre-Index Period [ Time Frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Number of participants with 25 most common medications use during the pre-index period are reported. The 25 most medications: 1) MTX sodium, 2) folic acid, 3) prednisone, 4) acetaminophen/hydrocodone bitartrate, 5) azithromycin, 6) adalimumab, 7) hydroxychloroquine sulfate, 8) etanercept, 9) levothyroxine sodium, 10) methylprednisolone, 11) omeprazole, 12) tramadol hydrochloride, 13) meloxicam, 14) amoxicillin, 15) albuterol sulfate, 16) gabapentin, 17) acetaminophen/oxycodone hydrochloride, 18) amoxicillin/clavulanate potassium, 19) cyclobenzaprine hydrochloride, 20) fluticasone propionate, 21) ciprofloxacin hydrochloride, 22) duloxetine hydrochloride, 23) atorvastatin calcium, 24) diclofenac sodium, 25) levofloxacin. A participant could have received >=1 most common medication.
  • Number of Participants With 26 Most Common Medications Use During Post-Index Period [ Time Frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Number of participants with 26 most common medications use during the post-index period are reported. The 26 most common medications: 1) MTX sodium, 2) folic acid, 3) prednisone, 4) acetaminophen/hydrocodone bitartrate, 5) azithromycin, 6) adalimumab, 7) hydroxychloroquine sulfate, 8) etanercept, 9) levothyroxine sodium, 10) methylprednisolone, 11) omeprazole, 12) tramadol hydrochloride, 13) meloxicam, 14) amoxicillin, 15) albuterol sulfate, 16) gabapentin, 17) acetaminophen/oxycodone hydrochloride, 18) amoxicillin/clavulanate potassium, 19) cyclobenzaprine hydrochloride, 20) fluticasone propionate, 21) ciprofloxacin hydrochloride, 22) duloxetine hydrochloride, 23) diclofenac Sodium, 24) levofloxacin, 25) cephalexin, 26) ibuprofen. A participant could have received >=1 most common medication.
  • Number of Participants Who Used Opioids During Pre-Index Period [ Time Frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Number of participants who used at least one opioid during pre-index period are reported.
  • Number of Participants Who Used Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) During Pre-Index Period [ Time Frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Number of participants who used at least one NSAID during pre-index period are reported.
  • Number of Participants Who Used Opioids During Post-Index Period [ Time Frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Number of participants who used at least one opioid during the post-index period are reported.
  • Number of Participants Who Used NSAIDs During Post-Index Period [ Time Frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Number of participants who used at least one NSAID during the post-index period are reported.
  • Mean Number of Pharmacy Claims for Opioids During Pre-Index Period [ Time Frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    The mean number of pharmacy claims for opioids during the pre-index period are reported. A pharmacy claim is defined as a claim made by participants to their insurance provider in purchasing opioids from their pharmacy.
  • Mean Number of Pharmacy Claims for Non-Steroidal Anti Inflammatory Drugs (NSAIDs) During Pre-Index Period [ Time Frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    The mean number of pharmacy claims for NSAIDs during the pre-index period are reported. A pharmacy claim is defined as a claim made by participants to their insurance provider in purchasing NSAIDs from their pharmacy.
  • Mean Number of Pharmacy Claims for Opioids During Post-Index Period [ Time Frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    The mean number of pharmacy claims for opioids during the post-index period are reported. A pharmacy claim is defined as a claim made by participants to their insurance provider in purchasing opioids from their pharmacy.
  • Mean Number of Pharmacy Claims for Non-Steroidal Anti Inflammatory Drugs (NSAIDs) During Post-Index Period [ Time Frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    The mean number of pharmacy claims for NSAIDs during the post-index period are reported. A pharmacy claim is defined as a claim made by participants to their insurance provider in purchasing NSAIDs from their pharmacy.
  • Mean Number of Days From The Index Date to The First Opioid Claim During Post Index Period [ Time Frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Mean number of days from the index date to the first opioid claim during post index period are reported.
  • Mean Number of Days From The Index Date to The First NSAIDs Claim During Post Index Period [ Time Frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Mean number of days from the index date to the first NSAIDs claim during post index period are reported.
  • Number of Participants Who Used Opioids During Tofacitinib Persistency and Post-Persistency [ Time Frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Number of participants who used opioids during tofacitinib persistency and post-persistency are reported. Persistence for participants is defined as the period of treatment with tofacitinib. Post persistence refers to switching to another medication from tofacitinib; or discontinuing tofacitinib either permanently or for a gap in time >60 days before restarting.
  • Number of Participants Who Used NSAIDs During Tofacitinib Persistency and Post-Persistency [ Time Frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Number of participants who used NSAIDs during tofacitinib persistency and post-persistency are reported. Persistence for participants is defined as the period of treatment with tofacitinib. Post persistence refers to switching to another medication from tofacitinib; or discontinuing tofacitinib either permanently or for a gap in time >60 days before restarting.
  • Number of Participants Who Used Oral Corticosteroids During Pre-Index Period [ Time Frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    The number of participants who used at least one oral corticosteroid during the pre-index period is reported.
  • Number of Participants Who Used Oral Corticosteroids During Post-Index Period [ Time Frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    The number of participants who used at least one oral corticosteroid during the post-index period is reported.
  • Mean Total Dose of Oral Corticosteroids During Pre-Index Period [ Time Frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Mean total dose of oral corticosteroids during pre-index period is reported. The total dose is expressed as a prednisone-equivalent dose of the oral corticosteroids used.
  • Mean Total Dose of Oral Corticosteroid During Post-Index Period [ Time Frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Mean total dose of oral corticosteroids during post-index period is reported. The total dose is expressed as a prednisone-equivalent dose of the oral corticosteroids used.
  • Mean Number of Visits to Rheumatologist During Pre-Index Period [ Time Frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Mean number of visits to a rheumatologist during pre-index period is reported. A visit is referring to out-patient visit specifically to a rheumatologist.
  • Mean Number of Visits to Rheumatologist During Variable-Length Pre-Index Period [ Time Frame: During variable length pre-index period (1 year before the index date up to 5.2 years) ]
    Mean number of visits to rheumatologist during the variable-length pre-index period is reported. A visit is referring to out-patient visit specifically to a rheumatologist. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.
  • Mean Disease Duration [ Time Frame: During variable length pre-index period (1 year before the index date up to 5.2 years) ]
    Mean Disease Duration of RA based upon the variable length pre-index period is reported. Disease duration (in days) defined as the number of days from the earliest claim with a diagnosis of RA in the variable length pre-index period until the index date. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.
  • Mean Out of Pocket Health Care Costs for Healthcare Services During Pre-Index Period [ Time Frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Mean out of pocket health care costs for healthcare services during pre-index period is reported. It is categorized as: All causes and RA related. All cause consisted of money spent by participants on all health care services (pharmacy, medical [ambulatory, emergency department and inpatient admission]). RA related signifies money spent by participants on health care services for RA.
  • Mean Out of Pocket Health Care Costs for Healthcare Services During Variable Length Pre-Index Period [ Time Frame: During variable length pre-index period (1 year before the index date up to 5.2 years) ]
    Mean out of pocket health care costs for healthcare services during variable length pre-index period is reported. It is categorized as: All causes and RA related. All cause consisted of money spent by participants on all health care services (pharmacy, medical [ambulatory, emergency department and inpatient admission]). RA related signifies one spent by participants on health care services for RA. Variable-length pre-index period defined as the period from the participant's first date of enrollment in the database to the day before the index date. The date of enrollment had to be at least 1 year prior to the index date and depending on the participant could have been as much as maximum of 5.2 years. The index date was the date of the first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.
  • Number of Participants With Comorbidities of Interest During Pre-Index Period [ Time Frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Number of participants with at least one of comorbidity of interest during pre-index period is reported. The comorbidities of interest included cardiovascular diseases, chronic obstructive pulmonary disorder (COPD), asthma, kidney disease, diabetes, depression, anxiety, liver disease, sleep disorders. A participant could have >1 comorbidity of interest.
  • Number of Participants With Non-persistence to Index Medication (Tofacitinib) [ Time Frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Non-persistence was defined as the gap of at least 60 days in treatment with the index medication (tofacitinib) or switching to other biologic.
  • Number of Participants With Post-Persistence Treatment Patterns [ Time Frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Number of participants with post-persistence treatment patterns is reported. Post-persistence was categorized as: 1) switch immediately (if participants initiated a non-index biologic before a 60-day gap in treatment is observed for the index medication); 2) discontinue then restart (if there was a gap in the index therapy of at least 60 days and the first medication observed after the gap is the index medication); 3) discontinue then switch ( if there was a gap in the index therapy of at least 60 days and the first medication observed after the gap is a biologic [including Tofacitinib] different from index medication), 4) discontinue without switch or restart (if participant's had a gap in therapy of at least 60 days and there are no claims for either the index medication or a different biologic for the remaining observation period).
  • Number of Participants Who Switched From Index Medication (Tofacitinib) at Any Time During Post-Index Period [ Time Frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Number of participants who switched from index medication (tofacitinib) to a biologic at any time during post-index period is reported.
  • Number of Participants Who Re-started Index Medication (Tofacitinib) at Any Time During Post-Index Period [ Time Frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Number of participants who re-started tofacitinib (after considered as non-persistence with the tofacitinib) after discontinuation at any time during post-index period is reported.
  • Mean Medication Possession Ratio (MPR) for Methotrexate (MTX) [ Time Frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Mean MPR for Methotrexate is reported. MPR was calculated as the total days supply of MTX 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.
  • Mean Adherence To Methotrexate (MTX) [ Time Frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Mean adherence for methotrexate is reported. Adherence was calculated as the total number of days supplied for MTX during the post-index period divided by the number of days from the first claim during the post-index period to the end of the post-index period
  • Number of Participants Who Used Additional NB-DMARD During Post Index Period [ Time Frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Number of participants who used additional NB-DMARD during post index period is reported. Additional NB-DMARD use could have been leflunomide, sulfasalazine and hydroxychloroquine.
  • Number of Participants Who Met Medication Effectiveness Criteria: Adherence to Index Medication (Tofacitinib) [ Time Frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Medication effectiveness criteria categorized as: 1) adherence to index medication, 2) no dose escalation for index medication, 3) no switch from index medication, 4) no addition of NB-DMARD, 5) criteria for oral glucocorticoids, 6) use of Injectable glucocorticoids. Adherence to index medication was defined as at least 30 days continuous supply of tofacitinib during post-index period.
  • Number of Participants Who Met Medication Effectiveness Criteria: No Dose Escalation for Index Medication (Tofacitinib) [ Time Frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Medication effectiveness criteria categorized as: 1) adherence to index medication, 2) no dose escalation for index medication, 3) no switch from index medication, 4) no addition of NB-DMARD, 5) criteria for oral glucocorticoids, 6) use of Injectable glucocorticoids. No dose escalation for index medication was defined as no increase in dose for index medication compared to the starting dose during post-index period.
  • Number of Participants Who Met Medication Effectiveness Criteria: No Switch From Index Medication (Tofacitinib) [ Time Frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Medication effectiveness criteria categorized as: 1) adherence to index medication, 2) no dose escalation for index medication, 3) no switch from index medication, 4) no addition of NB-DMARD, 5) criteria for oral glucocorticoids, 6) use of Injectable glucocorticoids. No switch from index medication was defined as no switching from the index medication to a (different) biologic agent during post-index period.
  • Number of Participants Who Met Medication Effectiveness Criteria: No Addition of NB-DMARD [ Time Frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Medication effectiveness criteria categorized as: 1) adherence to index medication, 2) no dose escalation for index medication, 3) no switch from index medication, 4) no addition of NB-DMARD, 5) criteria for oral glucocorticoids, 6) use of Injectable glucocorticoids. No addition of NB-DMARD was defined as no addition of new NB-DMARD to index therapy during post-index period.
  • Number of Participants Who Met Medication Effectiveness Criteria: Criteria for Oral Glucocorticoids [ Time Frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Medication effectiveness criteria categorized as: 1) adherence to index medication, 2) no dose escalation for index medication, 3) no switch from index medication, 4) no addition of NB-DMARD, 5) criteria for oral glucocorticoids, 6) use of Injectable glucocorticoids. Medication effectiveness criteria for oral glucocorticoids was defined as either of the following: 1) Participants cannot receive oral glucocorticoids for > 30 days between (index date +91 days) to (index date + 359 days); 2) No increase in oral glucocorticoid dose during months 6-12 after index date.
  • Number of Participants Who Met Medication Effectiveness Criteria: Use of Injectable Glucocorticoids [ Time Frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Medication effectiveness criteria categorized as: 1) adherence to index medication, 2) no dose escalation for index medication, 3) no switch from index medication, 4) no addition of NB-DMARD, 5) criteria for oral glucocorticoids, 6) use of Injectable glucocorticoids. Use of Injectable glucocorticoids was defined as maximum one parenteral or intra-articular glucocorticoid joint injection use after the participant had been on biologic treatment for >3 months post index date ([index date +91 days] to [index date +359 days]).
  • Number of Participants With All Cause Ambulatory Visits During Pre-Index Period [ Time Frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Number of participants with at least one ambulatory visit that was due to all cause during the pre-index period is reported. All cause refers to ambulatory visits due to all comorbidities, including RA.
  • Number of Participants With All Cause Emergency Department Visits During Pre-Index Period [ Time Frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Number of participants with at least one emergency department visits that was due to all cause during the pre-index period is reported. All cause refers to emergency visits due to all comorbidities, including RA.
  • Number of Participants With All Cause Inpatient Admissions During Pre-Index Period [ Time Frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Number of participants with at least one inpatient admissions that was due to all cause during the pre-index period is reported. All cause refers to inpatient admission due to all comorbidities, including RA.
  • Number of Participants With RA Related Ambulatory Visits During Pre-Index Period [ Time Frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Number of participants with at least one ambulatory visit that was due to RA during the pre-index period is reported. RA related refers to ambulatory visits due to RA.
  • Number of Participants With RA Related Emergency Department Visits During Pre-Index Period [ Time Frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Number of participants with at least one emergency department visits that was due to RA during the pre-index period is reported. RA related refers to emergency department visits due to RA.
  • Number of Participants With RA Related Inpatient Admissions During Pre-Index Period [ Time Frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Number of participants with at least one inpatient admissions that was due to RA during the pre-index period is reported. RA related refers to inpatient admission due to RA.
  • Number of Participants With All Cause Ambulatory Visits During Post-Index Period [ Time Frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Number of participants with at least one ambulatory visit that was due to all cause during the post-index period is reported. All cause refers to ambulatory visits due to all comorbidities, including RA.
  • Number of Participants With All Cause Emergency Department Visits During Post-Index Period [ Time Frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Number of participants with at least one emergency department visits that was due to all cause during the post-index period is reported. All cause refers to emergency department visits due to all comorbidities, including RA.
  • Number of Participants With All Cause Inpatient Admissions During Post-Index Period [ Time Frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Number of participants with at least one inpatient admissions that was due to all cause during the post-index period is reported. All cause refers to inpatient admissions due to all comorbidities, including RA.
  • Number of Participants With RA Related Ambulatory Visits During Post Index Period [ Time Frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Number of participants with at least one of the RA-related ambulatory visits during the post-index period is reported. RA related refers to ambulatory visits due to RA.
  • Number of Participants With RA Related Emergency Department Visits During Post Index Period [ Time Frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Number of participants with at least one of the RA-related emergency department visit during the post-index period is reported. RA related refers to emergency department visits due to RA.
  • Number of Participants With RA Related Inpatient Admissions During Post Index Period [ Time Frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Number of participants with at least one of an RA-related inpatient admission during the post-index period is reported. RA related refers to inpatient admissions due to RA.
  • Mean Total Health Care Cost All Cause During Pre-Index Period [ Time Frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Mean total health care cost all cause during pre-index period is reported. All cause refers to cost spent due to all comorbidities including RA and 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).
  • Mean Total Health Care Cost RA Related During Pre-Index Period [ Time Frame: During pre-index period (12 months duration before the index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    RA related healthcare cost refers to cost spent due to RA alone and was calculated as the total of treatment cost (cost of tofacitinib, biologic DMARDs, NB-DMARDs and administration of intravenous (IV) biologics) and medical cost (cost of ambulatory cost, emergency department visits cost, inpatient admission cost, home health care cost, urgent care cost and other medical services cost).
  • Mean Total Health Care Cost Due to All Cause During Post-Index Period [ Time Frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Mean total health care cost due to all cause during post-index period is reported. All cause refers to cost spent due to all comorbidities, including RA and calculated as the total of pharmacy cost (cost of home healthcare cost, urgent care cost and other medical services costs) and medical cost (cost of ambulatory cost, emergency department visits cost, inpatient admission cost and other costs).
  • Mean Total Health Care Cost RA Related During Post-Index Period [ Time Frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    RA related healthcare cost refers to cost spent due to RA alone and was calculated as the total of treatment cost (cost of tofacitinib, biologic DMARDs, NB-DMARDs and administration of IV biologics) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost, home health care cost, urgent care cost and other medical services cost).
  • Mean Treatment Persistence Duration Measured for Index Medication (Tofacitinib) [ Time Frame: During post-index period (12 months duration post index date [Index date: date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years]) ]
    Treatment persistence with tofacitinib was defined as not having a gap in therapy of at least 60 days between prescription re-fills of tofacitinib.
Original Primary Outcome Measures
 (submitted: June 4, 2019)
Treatment persistence duration measured with index medication [ Time Frame: 12 months post treatment initiation ]
Non-persistence will be identified based on a gap in treatment with the index medication or switching to another biologic in the 12 months post treatment initiation. Persistence with the index medication will be defined as not having a gap in therapy of at least 60 days between fills/infusions.
Change History Complete list of historical versions of study NCT03975790 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 28, 2019)
  • Mean Total All Cause Monthly Health Care Cost [ Time Frame: During pre-index period (at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 months before index date) and post index period (at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 month post index date) ]
    Mean total monthly health care cost due to all cause is reported. All cause refers to cost spent due to all comorbidities, including RA and calculated as the total of pharmacy cost (cost of home healthcare cost, urgent care cost and other medical services costs) and medical cost (cost of ambulatory cost, emergency department visits cost, inpatient admission cost and other costs). Total all cause monthly health care cost is reported for every month from 12 months duration before index date (pre-index period) to 12 months duration post index date (post index period). Index date is defined as the date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.
  • Mean Total RA Related Monthly Health Care Cost [ Time Frame: During pre-index period (at1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 months before index date) and post index period (at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 month after index date) ]
    Mean total monthly health care cost due to RA is reported. RA related refers to cost spent by participants due to RA on health care services. This is calculated as the total of treatment cost (cost of tofacitinib, biologic DMARDs, NB-DMARDs and administration of IV biologics) and medical cost (ambulatory cost, emergency department visits cost, inpatient admission cost, home health care cost, urgent care cost and other medical services cost). RA related monthly health care cost is reported for every month from 12 months duration before index date (pre-index period) to 12 months duration post index date (post index period). Index date is defined as the date of first claim for tofacitinib made by participants to their insurance provider during identification period of 3 years.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comparative Analysis of Outcomes Among Patients Initiating Xeljanz in Combination With Oral MTX Who Withdraw MTX Versus Continue MTX
Official Title Comparative Analysis of Outcomes Among Patients Initiating Xeljanz in Combination With Oral MTX Who Withdraw MTX Versus Continue MTX Using a United States Healthcare Claims Database
Brief Summary To address the objectives, a retrospective cohort design will be employed to evaluate patient characteristics, treatment patterns, medication effectiveness, and health care cost and utilization in RA patients newly initiating tofacitinib in combination with oral methotrexate (MTX)
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Individuals who are privately insured and with Medicare Supplemental insurance
Condition Rheumatoid Arthritis
Intervention Not Provided
Study Groups/Cohorts Truven Health MarketScan Research Database
Compare treatment patterns including dosing, concomitant medication use, adherence, persistence, and switching among tofacitinb+MTX patients who withdraw MTX vs. persist with MTX or experience interrupted MTX
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 28, 2019)
479
Original Actual Enrollment
 (submitted: June 4, 2019)
1
Actual Study Completion Date October 2, 2018
Actual Primary Completion Date October 2, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • At least one claim for tofacitinib between 01 January 2014 and 31 January 2017 (the identification period).
  • Presence of The International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9 CM) code for RA (in any position) during the one-year pre-index period or on the index date. ICD-9 = 714.0x-714.4x & 714.81 or ICD10 = M05.* & M06.0*-M06.3* or M06.8*-M06.9*.
  • At least 18 years old as of the index date.

Exclusion Criteria:

  • Patients with claims for other conditions for which biologics are used during the one-year pre-index period or on the index date: ankylosing spondylitis, Crohn's disease, psoriasis, psoriatic arthritis, or ulcerative colitis will be excluded from the study.
  • Patients with evidence of the index medication during the one-year pre-index period will be removed from the analysis. Patients will be allowed to have been treated with other biologics approved for RA (Tumor-Necrosis Factor-alpha inhibitors (TNFi) [adalimumab (Humira), etanercept (Enbrel), certolizumab pegol (Cimzia), golimumab (Simponi), infliximab (Remicade)] and non-TNFi's with alternative mechanisms of action [abatacept (Orencia), and rituximab (Rituxan), anakinra (Kineret), tocilizumab (Actemra)]) during the one-year pre-index period.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03975790
Other Study ID Numbers A3921336
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
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.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2019