ClinicalTrials.gov
Cure8 trial brief
Why This Matters
Tofacitinib has been linked to increased risk of venous thromboembolism in other post‑marketing safety studies; this trial examines coagulation and platelet effects in UC patients, which could help clarify mechanisms and inform safer use.
Who Should Pay Attention
Adults with ulcerative colitis, particularly those considering or taking tofacitinib; clinicians prescribing JAK inhibitors or biologics; researchers studying thromboembolic risk with IBD therapies.
Study Snapshot
Story typeClinical Reference
Trial phasePhase 4
Enrollment32 participants
Study statusCompleted
Source depthTrial registry record
What To Know
This is a ClinicalTrials.gov record for a completed, single-center, post-authorization interventional study assessing effects of tofacitinib versus anti‑TNF therapies on coagulation, platelet function, and thromboembolic risk in patients with ulcerative colitis.
The protocol enrolls patients treated in routine practice (no randomization); tofacitinib is used per local protocol, typically after failure of anti‑TNF or vedolizumab. The trial was initiated by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa.
Keep In Mind
This record is a trial registry entry (trial-record). The study is non-randomized and observational within routine clinical practice, so results would be descriptive and may be affected by selection and confounding.
Prior large safety trials in rheumatoid arthritis prompted regulatory warnings about higher thromboembolism risk with higher tofacitinib doses; regulators recommend caution in patients with VTE risk factors.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorFundación de Investigación Biomédica - Hospital Universitario de La Princesa
Trial IDNCT05313620
Study typeInterventional
Trial phasePhase 4
Enrollment32 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedSep 18, 2026, 12:00 AM
Content availableTrial registry record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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