Last reviewed · How we verify

NCT03975790

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

Completed Results posted Last updated 9 June 2023
What this trial tests

trial in Rheumatoid Arthritis in 479 participants. Completed in 2 October 2018.

Timeline
29 May 2018
Primary endpoint
2 October 2018
2 October 2018

Quick facts

Lead sponsorPfizer
StatusCompleted
Study typeOBSERVATIONAL
Enrollment479
Start date29 May 2018
Primary completion2 October 2018
Estimated completion2 October 2018
Sites1 location across United States

Conditions studied

Sponsor

Pfizer — full company profile →

Who can join

18 and older, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants as Per Type of Insurance Plan Primary · 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.

GroupValue95% CI
Methotrexate (MTX) + Tofacitinib: MTX Persistent36
Methotrexate (MTX) + Tofacitinib: MTX Discontinued13
Methotrexate (MTX) + Tofacitinib: MTX Interrupted9
Methotrexate (MTX) + Tofacitinib: MTX Persistent301
Methotrexate (MTX) + Tofacitinib: MTX Discontinued81
Methotrexate (MTX) + Tofacitinib: MTX Interrupted39
Number of Participants in Each Geographic Region Primary · 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.

GroupValue95% CI
Methotrexate (MTX) + Tofacitinib: MTX Persistent81
Methotrexate (MTX) + Tofacitinib: MTX Discontinued25
Methotrexate (MTX) + Tofacitinib: MTX Interrupted10
Methotrexate (MTX) + Tofacitinib: MTX Persistent76
Methotrexate (MTX) + Tofacitinib: MTX Discontinued17
Methotrexate (MTX) + Tofacitinib: MTX Interrupted14
Methotrexate (MTX) + Tofacitinib: MTX Persistent150
Methotrexate (MTX) + Tofacitinib: MTX Discontinued47
Methotrexate (MTX) + Tofacitinib: MTX Interrupted21
Methotrexate (MTX) + Tofacitinib: MTX Persistent29
Methotrexate (MTX) + Tofacitinib: MTX Discontinued5
Methotrexate (MTX) + Tofacitinib: MTX Interrupted3
Number of Participants With Biologic Disease Modifying Antirheumatic Drug (bDMARD) Use During Pre-Index Period Primary · 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.

GroupValue95% CI
Methotrexate (MTX) + Tofacitinib: MTX Persistent225
Methotrexate (MTX) + Tofacitinib: MTX Discontinued59
Methotrexate (MTX) + Tofacitinib: MTX Interrupted31
Number of Participants With Biologic Disease Modifying Antirheumatic Drug (bDMARD) Use During Variable Length Pre-Index Period Primary · 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

GroupValue95% CI
Methotrexate (MTX) + Tofacitinib: MTX Persistent247
Methotrexate (MTX) + Tofacitinib: MTX Discontinued69
Methotrexate (MTX) + Tofacitinib: MTX Interrupted36
Mean Number of Biologic Disease Modifying Antirheumatic Drug (bDMARD) Received During Pre-Index Period Primary · 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.

GroupValue95% CI
Methotrexate (MTX) + Tofacitinib: MTX Persistent1.38± 0.59
Methotrexate (MTX) + Tofacitinib: MTX Discontinued1.31± 0.46
Methotrexate (MTX) + Tofacitinib: MTX Interrupted1.23± 0.50
Mean Number of Biologic Disease Modifying Antirheumatic Drug (bDMARD) Received During Variable Length Pre-Index Period Primary · 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 cl

GroupValue95% CI
Methotrexate (MTX) + Tofacitinib: MTX Persistent1.81± 0.87
Methotrexate (MTX) + Tofacitinib: MTX Discontinued1.55± 0.76
Methotrexate (MTX) + Tofacitinib: MTX Interrupted1.50± 0.61
Number of Participants With Non-biologic Disease Modifying Antirheumatic Drug (NB-DMARD) Use During Pre-Index Period Primary · 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.

GroupValue95% CI
Methotrexate (MTX) + Tofacitinib: MTX Persistent333
Methotrexate (MTX) + Tofacitinib: MTX Discontinued93
Methotrexate (MTX) + Tofacitinib: MTX Interrupted47
Number of Participants With Non-Biologic Disease Modifying Antirheumatic Drug (NB-DMARD) Use During Variable Length Pre-Index Period Primary · 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 partici

GroupValue95% CI
Methotrexate (MTX) + Tofacitinib: MTX Persistent334
Methotrexate (MTX) + Tofacitinib: MTX Discontinued94
Methotrexate (MTX) + Tofacitinib: MTX Interrupted48
Mean Number of Non-Biologic Disease Modifying Antirheumatic Drug (NB-DMARD) Received During Pre-Index Period Primary · 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.

GroupValue95% CI
Methotrexate (MTX) + Tofacitinib: MTX Persistent1.46± 0.67
Methotrexate (MTX) + Tofacitinib: MTX Discontinued1.41± 0.63
Methotrexate (MTX) + Tofacitinib: MTX Interrupted1.40± 0.65
Mean Number of Non-Biologic Disease Modifying Antirheumatic Drug (NB-DMARD) Received During Variable Length Pre-Index Period Primary · 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 co

GroupValue95% CI
Methotrexate (MTX) + Tofacitinib: MTX Persistent1.62± 0.77
Methotrexate (MTX) + Tofacitinib: MTX Discontinued1.52± 0.70
Methotrexate (MTX) + Tofacitinib: MTX Interrupted1.63± 0.82
Mean Quan-Charlson Comorbidity Score of Participants Primary · 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.

GroupValue95% CI
Methotrexate (MTX) + Tofacitinib: MTX Persistent1.69± 1.08
Methotrexate (MTX) + Tofacitinib: MTX Discontinued1.76± 1.18
Methotrexate (MTX) + Tofacitinib: MTX Interrupted1.90± 1.46
Number of Participants With Top 25 Comorbid Conditions as Per Agency for Healthcare Research and Quality (AHRQ) During Pre-Index Period Primary · 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)o

Rheumatoid arthritis/related disease
GroupValue95% CI
Methotrexate (MTX) + Tofacitinib: MTX Persistent337
Methotrexate (MTX) + Tofacitinib: MTX Discontinued94
Methotrexate (MTX) + Tofacitinib: MTX Interrupted48
Other aftercare
GroupValue95% CI
Methotrexate (MTX) + Tofacitinib: MTX Persistent277
Methotrexate (MTX) + Tofacitinib: MTX Discontinued68
Methotrexate (MTX) + Tofacitinib: MTX Interrupted36
Other connective tissue disease
GroupValue95% CI
Methotrexate (MTX) + Tofacitinib: MTX Persistent203
Methotrexate (MTX) + Tofacitinib: MTX Discontinued66
Methotrexate (MTX) + Tofacitinib: MTX Interrupted26
Other non-traumatic joint disorders
GroupValue95% CI
Methotrexate (MTX) + Tofacitinib: MTX Persistent200
Methotrexate (MTX) + Tofacitinib: MTX Discontinued56
Methotrexate (MTX) + Tofacitinib: MTX Interrupted29
Medical examination/evaluation
GroupValue95% CI
Methotrexate (MTX) + Tofacitinib: MTX Persistent195
Methotrexate (MTX) + Tofacitinib: MTX Discontinued56
Methotrexate (MTX) + Tofacitinib: MTX Interrupted24
Other suspected conditions
GroupValue95% CI
Methotrexate (MTX) + Tofacitinib: MTX Persistent179
Methotrexate (MTX) + Tofacitinib: MTX Discontinued49
Methotrexate (MTX) + Tofacitinib: MTX Interrupted21
Immunizations/screening for infectious disease
GroupValue95% CI
Methotrexate (MTX) + Tofacitinib: MTX Persistent176
Methotrexate (MTX) + Tofacitinib: MTX Discontinued44
Methotrexate (MTX) + Tofacitinib: MTX Interrupted19
Osteoarthritis
GroupValue95% CI
Methotrexate (MTX) + Tofacitinib: MTX Persistent154
Methotrexate (MTX) + Tofacitinib: MTX Discontinued37
Methotrexate (MTX) + Tofacitinib: MTX Interrupted28

Sponsor's own description

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)

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Auranofin and its analogs as prospective agents for the treatment of colorectal cancer.
    Massai L, Cirri D, Marzo T, Messori L. · · 2022 · cited 21× · PMID 35582525 · DOI 10.20517/cdr.2021.71

Verify or expand the search:

Other recruiting trials for Rheumatoid Arthritis

Currently open trials in the same condition.

Other Pfizer trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03975790.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing