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.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| All TNFi initiations
|
Other: patterns of use of combination therapy and monotherapy
|
| TNFi initiations after 11/6/2012 for comparisons with Tofacitinib initiators
|
Other: patterns of use of combination therapy and monotherapy
|
| RA patient in Corrona with initiation Tofacitinib during follow-up in Corron
|
Other: patterns of use of combination therapy and monotherapy
|
Outcome Measures
Primary Outcome Measures
- 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
- Achievement of LDA or remission based on CDAI score [6 months]
Estimate and compare efficacy in patients on TNFi monotherapy vs TNFi combination with MTX
- Achievement of LDA or remission based on CDAI score [6 months]
Estimate and compare efficacy in patients on Tofacitinib monotherapy vs TNFi combination with MTX
- Achievement of LDA or remission based on CDAI score [6 months]
Estimate and compare efficacy in patients on Tofacitinib monotherapy 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 combination with MTX
- 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
- Achievement of mACR20 [6 months]
Estimate and compare efficacy in patients on tofacitinib monotherapy vs tofacitinib with MTX
- Achievement of mACR20 [6 months]
Estimate and compare efficacy in patients on TNFi monotherapy vs TNFi combination with MTX
- Achievement of mACR20 [6 months]
Estimate and compare efficacy in patients on Tofacitinib monotherapy vs TNFi combination with MTX
- Achievement of mACR20 [6 months]
Estimate and compare efficacy in patients on Tofacitinib monotherapy vs TNFi monotherapy
- Achievement of mACR20 [6 months]
Estimate and compare efficacy in patients on Tofacitinib combination with MTX vs TNFi combination with MTX
- Achievement of mACR20 [6 months]
Estimate and compare efficacy in patients on Tofacitinib combination with MTX vs. TNFi 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 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.
- 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.
- Median age, years [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.
- 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.
- Percent bDMARD-naïve [Baseline]
Describe and compare demographic and clinical characteristics of patients initiating combination therapy vs monotherapy.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer | New York | New York | United States | 10017 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- A3921422