N/A
N=9,159
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
Bottom Line
View on ClinicalTrials.gov: NCT05576051 ↗Enrolled (actual)
9,159
Serious AEs
—
Results posted
Dec 2025
Primary outcome: Primary: Clinical Disease Activity Index (CDAI) Score at 6 Months for Tofacitinib Monotherapy vs Tofacitinib With Methotrexate (MTX) — 18.1; 17; 16.6; 14.6 Units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- patterns of use of combination therapy and monotherapy (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Disease Activity Index (CDAI) Score at 6 Months for Tofacitinib Monotherapy vs Tofacitinib With Methotrexate (MTX) |
18.1; 17; 16.6; 14.6 | — |
| SECONDARY CDAI Score at 6 Months for Tumor Necrosis Factor Inhibitor (TNFi) Monotherapy vs TNFi Combination With MTX |
13.9; 16.5; 13; 14.9 | — |
| SECONDARY CDAI Score at 6 Months for Tofacitinib Monotherapy vs TNFi Combination With MTX |
13.9; 17; 13; 14.6 | — |
| SECONDARY CDAI Score at 6 Months for Tofacitinib Combination With MTX vs TNFi Monotherapy |
16.5; 18.1; 14.9; 16.6 | — |
| SECONDARY CDAI Score at 6 Months for Tofacitinib Combination With MTX vs TNFi Combination With MTX |
13.9; 18.1; 13; 16.6 | — |
| SECONDARY CDAI Score at 6 Months for Tofacitinib Monotherapy vs TNFi Monotherapy |
16.5; 17; 14.9; 14.6 | — |
| SECONDARY Number of Participants With Modified American College of Rheumatology 20% (mACR20) at 6 Months for Tofacitinib Monotherapy vs Tofacitinib With MTX |
19; 28 | — |
| SECONDARY Number of Participants With mACR20 at 6 Months for TNFi Monotherapy vs TNFi Combination With MTX |
1224; 394 | — |
| SECONDARY Number of Participants With mACR20 at 6 Months for Tofacitinib Monotherapy vs TNFi Combination With MTX |
1224; 28 | — |
| SECONDARY Number of Participants With mACR20 at 6 Months for Tofacitinib Monotherapy vs TNFi Monotherapy |
394; 28 | — |
| SECONDARY Number of Participants With mACR20 at 6 Months for Tofacitinib Combination With MTX vs TNFi Combination With MTX |
1224; 19 | — |
| SECONDARY Number of Participants With mACR20 at 6 Months for Tofacitinib Combination With MTX vs TNFi Monotherapy |
394; 19 | — |
| SECONDARY Number of Participants According to Line of Therapy at TNFi Initiation |
203; 89; 2109; 616; 1088; 581 | — |
| SECONDARY Number of Participants According to Line of Therapy at TNFi Initiation After 11/6/2012 |
54; 361; 388; 123; 212; 118 | — |
| SECONDARY Number of Participants According to Line of Therapy at Tofacitinib Initiation |
6; 12; 12; 12; 11; 22 | — |
| SECONDARY Median CDAI Score at Baseline- TNFi Initiator |
18.6; 19.7 | 0.278 |
| SECONDARY Median CDAI Score at Baseline- Tofacitinib Initiator |
22.1; 19 | 0.131 |
| SECONDARY Median CDAI Score at Baseline- TNFi Initiator After 11-6-2012 |
19.5; 21 | 0.987 |
| SECONDARY Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation |
975; 634; 1286; 872; 707; 434 | — |
| SECONDARY Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) Use at TNFi Initiation After 11/6/2012 |
233; 176; 246; 194; 147; 93 | — |
| SECONDARY Number of Participants According to Prior Biologic for Line of Therapy of Prior Biologics (Restricted to 3+ Line of Therapy: Prior Use of at Least One Biologic) at Tofacitinib Initiation |
72; 109; 61; 123; 41; 82 | — |
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
Data sourced from ClinicalTrials.gov (NCT05576051). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.