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 |
|