drugset / Trial / NCT05313620
Effect of Tofacitinib on Coagulation and Platelet Function, and Its Role in Thromboembolic Events
Phase 4
Recruiting
30 enrolled
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Non-randomizedParallel-groupOpen-labelTreatment
Summary
Post-authorization, prospective and unicenter clinical trial, in which patients with UC will be included. The treatment with anti-TNFα (infliximab, adalimumab or golimumab) or JAK-inhibitors (tofacitinib) will be initiated by clinical practice and the choice will be made at the discretion of the investigator at the center where the patients will be recruited (Hospital Universitario de La Princesa). In the case of the group of patients treated with tofacitinib, the selection will be made following the action protocol implemented in our center, in which this drug is usually reserved for those cases refractory to anti-TNFα and/or vedolizumab. There will be no random assignment of treatment. The drugs will be used in the approved indications and conditions of use.
Timeline
- Start
- 2022-04-01
- Primary completion
- 2025-12
- Completion
- 2025-12
Publications
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- Background Chaparro M, Garre A, Mesonero F, Rodriguez C, Barreiro-de Acosta M, Martinez-Cadilla J, Arroyo MT, Mancenido N, Sierra-Ausin M, Vera-Mendoza I, Casanova MJ, Nos P, Gonzalez-Munoza C, Martinez T, Bosca-Watts M, Calafat M, Busquets D, Girona E, Llao J, Martin-Arranz MD, Piqueras M, Ramos L, Suris G, Bermejo F, Carbajo AY, Casas-Deza D, Fernandez-Clotet A, Garcia MJ, Ginard D, Gutierrez-Casbas A, Hernandez L, Lucendo AJ, Marquez L, Merino-Ochoa O, Rancel FJ, Taxonera C, Lopez Sanroman A, Rubio S, Domenech E, Gisbert JP. Tofacitinib in Ulcerative Colitis: Real-world Evidence From the ENEIDA Registry. J Crohns Colitis. 2021 Jan 13;15(1):35-42. doi: 10.1093/ecco-jcc/jjaa145.
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- Background Sandborn WJ, Panes J, Sands BE, Reinisch W, Su C, Lawendy N, Koram N, Fan H, Jones TV, Modesto I, Quirk D, Danese S. Venous thromboembolic events in the tofacitinib ulcerative colitis clinical development programme. Aliment Pharmacol Ther. 2019 Nov;50(10):1068-1076. doi: 10.1111/apt.15514. Epub 2019 Oct 9.
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Adalimumab | Monoclonal antibody | 40 mg | Subcutaneous |
| Comparator | Golimumab | Monoclonal antibody | 50 mg | Subcutaneous |
| Comparator | Infliximab | Monoclonal antibody | 5 mg/kg | Intravenous |
| Subject | Tofacitinib | Small molecule | 5 mg | Oral |