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.

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Other: patterns of use of combination therapy and monotherapy

• Registration Number: NCT05576051
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-04
• Primary Completion: 2015-10-07
• Study Completion: 2015-10-07
• Study First Submitted: 2022-10-07
• Study First Submitted QC: 2022-10-07
• Study First Posted: 2022-10-12
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TNFi initiations after 11/6/2012 for comparisons with Tofacitinib initiators	patterns of use of combination therapy and monotherapy	-
All TNFi initiations	patterns of use of combination therapy and monotherapy	-
RA patient in Corrona with initiation Tofacitinib during follow-up in Corron	patterns of use of combination therapy and monotherapy	-

Primary Outcome Measures

Name	Time	Method
Achievement of LDA or remission based on CDAI score	6 months	Estimate and compare efficacy in patients on tofacitinib monotherapy vs tofacitinib with MTX

Secondary Outcome Measures

Name	Time	Method
Proportion of patients 4th line or later (prior use of at least one csDMARD and prior use of 2+ biologics)	Baseline	Describe line of therapy and prior medication use for patients initiating combination therapy and monotherapy with TNFi or Tofacitinib.
Median age, years	Baseline	Describe and compare demographic and clinical characteristics of patients initiating combination therapy vs monotherapy.
Percent bDMARD-naïve	Baseline	Describe and compare demographic and clinical characteristics of patients initiating combination therapy vs monotherapy.
Percent Female	Baseline	Describe and compare demographic and clinical characteristics of patients initiating combination therapy vs monotherapy.
Percent White	Baseline	Describe and compare demographic and clinical characteristics of patients initiating combination therapy vs monotherapy.
Proportion of patients in 1st line (no prior use of any DMARD at time of initiation)	Baseline	Describe line of therapy and prior medication use for patients initiating combination therapy and monotherapy with TNFi or Tofacitinib
Proportion of patients 2nd line (prior use of at least one csDMARD and no prior use of any biologic)	Baseline	Describe line of therapy and prior medication use for patients initiating combination therapy and monotherapy with TNFi or Tofacitinib.
Proportion of patients 3rd line (prior use of at least one csDMARD and prior use of 1 biologic)	Baseline	Describe line of therapy and prior medication use for patients initiating combination therapy and monotherapy with TNFi or Tofacitinib.
Proportion of 3rd line + patients with exposure to adalimumab, etanercept, infliximab, golimumab, certolizumab pegol, abatacept, rituximab, tocilizumab, or anakinra	Baseline	Describe line of therapy and prior medication use for patients initiating combination therapy and monotherapy with TNFi or Tofacitinib.
Achievement of mACR20	6 months	Estimate and compare efficacy in patients on Tofacitinib combination with MTX vs. TNFi monotherapy
Achievement of LDA or remission based on CDAI score	6 months	Estimate and compare efficacy in patients on Tofacitinib combination with MTX vs. TNFi monotherapy
Median duration of RA in years	Baseline	Describe and compare demographic and clinical characteristics of patients initiating combination therapy vs monotherapy.
Median CDAI	Baseline	Describe and compare demographic and clinical characteristics of patients initiating combination therapy vs monotherapy.

Trial Locations

Locations (1)

Pfizer; 🇺🇸 New York, New York, United States