Clinical trial NCT05576051: To Estimate the Efficacy of Treatment With TNFi as Monotherapy or Combination Therapy With MTX and Compare and Contrast Efficacy With Tofacitinib as Monotherapy and Combination Therapy in a Real World Setting.
Official title: Epidemiology and Efficacy of TNFi Combination Therapy (MTX+TNFi), TNFi Monotherapy, Tofacitinib Combination Therapy and Tofacitinib Monotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-10-12
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Observational retrospective data using the Corrona RA Registry

Brief summary: To estimate the efficacy of treatment with TNFi as monotherapy or combination therapy with MTX and compare and contrast efficacy with Tofacitinib as monotherapy and combination therapy in a real world setting.


Eligibility criteria: Inclusion Criteria:

* RA patients in Corrona initiating a TNFi biologic (adalimumab, etanercept, infliximab, golimumab, certolizumab pegol) during follow-up in Corrona with no prior use of Tofacitinib

Exclusion Criteria:

* Patients with no history of cDMARD but history of 1+ biologics - these cases will be excluded from analyses
* Patients using combination therapy with a cDMARD other than MTX will be excluded
* Patients using combination therapy of MTX and another cDMARD will be excluded

Primary outcomes:
measure: Achievement of LDA or remission based on CDAI score
timeFrame: 6 months
Secondary outcomes:
measure: Achievement of LDA or remission based on CDAI score
timeFrame: 6 months
measure: Achievement of LDA or remission based on CDAI score
timeFrame: 6 months
measure: Achievement of LDA or remission based on CDAI score
timeFrame: 6 months
measure: Achievement of LDA or remission based on CDAI score
timeFrame: 6 months
measure: Achievement of LDA or remission based on CDAI score
timeFrame: 6 months
measure: Achievement of mACR20
timeFrame: 6 months
measure: Achievement of mACR20
timeFrame: 6 months
measure: Achievement of mACR20
timeFrame: 6 months
measure: Achievement of mACR20
timeFrame: 6 months
measure: Achievement of mACR20
timeFrame: 6 months
measure: Achievement of mACR20
timeFrame: 6 months
measure: Proportion of patients in 1st line (no prior use of any DMARD at time of initiation)
timeFrame: Baseline
measure: Proportion of patients 2nd line (prior use of at least one csDMARD and no prior use of any biologic)
timeFrame: Baseline
measure: Proportion of patients 3rd line (prior use of at least one csDMARD and prior use of 1 biologic)
timeFrame: Baseline
measure: Proportion of patients 4th line or later (prior use of at least one csDMARD and prior use of 2+ biologics)
timeFrame: Baseline
measure: Proportion of 3rd line + patients with exposure to adalimumab, etanercept, infliximab, golimumab, certolizumab pegol, abatacept, rituximab, tocilizumab, or anakinra
timeFrame: Baseline
measure: Median age, years
timeFrame: Baseline
measure: Percent Female
timeFrame: Baseline
measure: Percent White
timeFrame: Baseline
measure: Median duration of RA in years
timeFrame: Baseline
measure: Median CDAI
timeFrame: Baseline
measure: Percent bDMARD-naïve
timeFrame: Baseline
Other outcomes:
Locations:
city: New York
country: United States
facility: Pfizer
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: