Clinical trial · Interventional
Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis
PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS
NCT02092467CI-TRIAL-00053337completedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This post-marketing study is designed to compare the safety of tofacitinib versus TNF inhibitor with respect to major cardiovascular adverse events and malignancies, excluding non-melanoma skin cancers when given to subjects with rheumatoid arthritis. Other safety events, including non-melanoma skin cancers, hepatic events, infections, and efficacy parameters will be collected and evaluated in the study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Arthritis, Rheumatoid | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adalimumab | Biological | — | UNRESOLVED |
| etanercept | Biological | — | UNRESOLVED |
| tofacitinib | Drug | Tofacitinib | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Treatment Arm 1
- interventionNames
- Drug: tofacitinib
- type
- EXPERIMENTAL
- label
- Treatment Arm 2
- interventionNames
- Drug: tofacitinib
- type
- ACTIVE_COMPARATOR
- label
- Treatment Arm 3
- description
- TNF inhibitor Arm - adalimumab will be used in US, Canada and Puerto Rico; etanercept will be used in all other countries.
- interventionNames
- Biological: adalimumab
- Biological: etanercept
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Moderate to severe rheumatoid arthritis * Taking methotrexate without adequate control of symptoms * Have at least one cardiovascular risk factor (eg, current smoker, high blood pressure, high cholesterol levels, diabetes mellitus, history of heart attack, family history of coronary heart disease, extra-articular RA disease) Exclusion Criteria: * Current or recent infection * Clinically significant laboratory abnormalities * Pregnancy
References
Publications (13)
- DERIVEDGiles JT, Charles-Schoeman C, Buch MH, Dougados M, Szekanecz Z, Mikuls TR, Ytterberg SR, Koch GG, Kwok K, Cadatal MJ, Menon S, Chen Y, Diehl AM, Rivas JL, Yndestad A, Bhatt DL. Use of statins and its association with major adverse cardiovascular events with tofacitinib vs TNF inhibitors in patients with rheumatoid arthritis with and without atherosclerotic cardiovascular disease. Ann Rheum Dis. 2026 Jan;85(1):103-113. doi: 10.1016/j.ard.2025.08.028. Epub 2025 Sep 23. PMID 40992967
- DERIVEDHetland ML, Strangfeld A, Bonfanti G, Soudis D, Deuring JJ, Edwards RA. Machine learning prediction and explanatory models of serious infections in patients with rheumatoid arthritis treated with tofacitinib. Arthritis Res Ther. 2024 Aug 27;26(1):153. doi: 10.1186/s13075-024-03376-9. PMID 39192350
- DERIVEDBatko B, Jeka S, Wiland P, Zielinska A, Stopinska-Polaszewska M, Stajszczyk M, Kosydar-Piechna M, Cadatal MJ, Rivas JL. Geographical Differences in the Safety and Efficacy of Tofacitinib Versus TNFi: A Post Hoc Analysis of ORAL Surveillance. Rheumatol Ther. 2024 Oct;11(5):1217-1235. doi: 10.1007/s40744-024-00693-y. Epub 2024 Jul 26. PMID 39060905
- DERIVEDCitera G, Mysler E, Kakehasi AM, Pascual-Ramos V, Masson W, Cadatal MJ, Rivas JL, Sheibanie F, Helling C, Ponce de Leon D. Cardiovascular Events, Malignancies, and Efficacy Outcomes in Latin American Patients With Rheumatoid Arthritis Receiving Tofacitinib or Tumor Necrosis Factor Inhibitors: A Post Hoc Analysis of the ORAL Surveillance Study. J Clin Rheumatol. 2024 Aug 1;30(5):208-216. doi: 10.1097/RHU.0000000000002106. Epub 2024 Jun 17. PMID 38880956
- DERIVEDBuch MH, Bhatt DL, Charles-Schoeman C, Giles JT, Mikuls T, Koch GG, Ytterberg S, Nagy E, Jo H, Kwok K, Connell CA, Masri KR, Yndestad A. Risk of extended major adverse cardiovascular event endpoints with tofacitinib versus TNF inhibitors in patients with rheumatoid arthritis: a post hoc analysis of a phase 3b/4 randomised safety study. RMD Open. 2024 Apr 12;10(2):e003912. doi: 10.1136/rmdopen-2023-003912. PMID 38609322