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.

Rheumatoid Arthritis Clinical Trial

Official title:

Epidemiology and Efficacy of TNFi Combination Therapy (MTX+TNFi), TNFi Monotherapy, Tofacitinib Combination Therapy and Tofacitinib Monotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05576051
• Other study ID #: A3921422
• Status: Completed
• Start date: June 4, 2015
• Est. completion date: October 7, 2015

Study information

• Verified date: April 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: October 7, 2015
• Est. primary completion date: October 7, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• patterns of use of combination therapy and monotherapy

Locations

Country	Name	City	State
United States	Pfizer	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

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