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Effect of Tofacitinib on coagulation and platelet function, and its role in thromboembolic events

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518434-83-01
Acronym
GIS-2021-JAKihemo
Enrollment
60
Registered
2024-11-20
Start date
2022-06-01
Completion date
Unknown
Last updated
2025-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ulcerative colitis

Brief summary

Platelet activation status will be assessed ex vivo in platelet-rich plasma (PRP) samples from UC patients (active and quiescent) and healthy controls incubated in the absence or presence of drug (tofacitinib or anti-TNFα). Regarding the in vivo study, platelet activation will be analyzed in samples from patients with active UC before and after initiating treatment with tofacitinib or anti-TNFα. It will be mesured by rate of platelet agregation

Detailed description

Endoscopic activity will be evaluated by the Mayo endoscopic sub-score; endoscopic activity will be considered as ≥ 2., Endoscopic response will be defined as a decrease of ≥ 1 point in the Mayo endoscopic sub-score 3 months after starting treatment., Endoscopic remission will be defined as an endoscopic subscore ≤1, 3 months after starting treatment.

Interventions

DRUGGOLIMUMAB
DRUGTOFACITINIB
DRUGINFLIXIMAB
DRUGADALIMUMAB

Sponsors

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Platelet activation status will be assessed ex vivo in platelet-rich plasma (PRP) samples from UC patients (active and quiescent) and healthy controls incubated in the absence or presence of drug (tofacitinib or anti-TNFα). Regarding the in vivo study, platelet activation will be analyzed in samples from patients with active UC before and after initiating treatment with tofacitinib or anti-TNFα. It will be mesured by rate of platelet agregation

Secondary

MeasureTime frame
Endoscopic activity will be evaluated by the Mayo endoscopic sub-score; endoscopic activity will be considered as ≥ 2., Endoscopic response will be defined as a decrease of ≥ 1 point in the Mayo endoscopic sub-score 3 months after starting treatment., Endoscopic remission will be defined as an endoscopic subscore ≤1, 3 months after starting treatment.

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026