Ulcerative colitis drugs put under the microscope for hidden clot risk
NCT ID NCT05313620
First seen Sep 18, 2026 · Last updated Sep 18, 2026
Summary
Researchers are studying how two types of ulcerative colitis treatment, tofacitinib and anti-TNF drugs, affect platelet function and the body's clotting system. The trial enrolls adults with ulcerative colitis and compares blood and tissue samples before and after they start treatment. By tracking platelet activation and gut healing, the team aims to understand whether one drug class carries a different risk of dangerous blood clots.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tofacitinib, compared with anti-TNF drugs infliximab, adalimumab, or golimumab
- What this could lead to
- If researchers learn how these drugs change platelet behavior, doctors could better judge who faces a higher clot risk and tailor ulcerative colitis treatment accordingly.
- What could go wrong
- The study is small, with 32 participants, and it does not randomly assign treatments, so differences between groups may reflect patient selection rather than the drugs themselves. It measures lab markers of clotting, not actual clot events, so the link to real-world risk remains uncertain.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
32 people
The number who actually took part.
- Started
-
Apr 2022
- Finished
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Jun 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: EX VIVO STUDY IN PATIENTS WITH UC PATIENTS WITH UC: * Over 18 years old. * Diagnosis of UC according to the criteria of the European Crohn's and Colitis Organisation (ECCO). * Previous treatments are allowed, provided they have remained stable for the past 3 months. * In the case of patients with active UC, they should have endoscopic activity within 1 month of starting the treatment (Mayo endoscopic sub-index of ≥ 2). * Women of childbearing age using contraceptive methods with an error rate \<1% per year. Examples of contraceptive methods whose error rate is \<1% per year are: 1. Intrauterine device (IUD). 2. Bilateral tubal occlusion. 3. Couple with vasectomy. 4. Sexual abstinence. INDIVIDUALS WITHOUT UC: * Over 18 years old. * Subjects not diagnosed with UC, or other inflammatory allergic, malignant or autoimmune diseases. * Women of childbearing age using contraceptive methods with an error rate \<1% per year. Examples of contraceptive methods whose error rate is \<1% per year are: 1. Intrauterine device (IUD). 2. Bilateral tubal occlusion. 3. Couple with vasectomy. 4. Sexual abstinence. IN VIVO STUDY IN PATIENTS WITH UC PATIENTS WITH UC: * Over 18 years old. * Diagnosis of UC according to the criteria of the European Crohn's and Colitis Organisation (ECCO). * Have indication of treatment with anti-TNFα (infliximab, adalimumab or golimumab) o tofacitinib. * Be the first received JAK-inhibitor or anti-TNFα with a given mechanism of action. * Have endoscopic activity of UC within 1 month of starting the treatment (Mayo endoscopic sub-index of ≥ 2). * Previous treatments (including corticosteroids and immunosuppressants) are allowed provided that they have been stable for the last 3 months before beginning treatment with JAK-inhibitor or anti-TNFα and that they are maintained at a stable dose for the duration of the study * Women of childbearing age using contraceptive methods with an error rate \<1% per year. Examples of contraceptive methods whose error rate is \<1% per year are: 1. Intrauterine device (IUD). 2. Bilateral tubal occlusion. 3. Couple with vasectomy. 4. Sexual abstinence. INDIVIDUALS WITHOUT UC: * Over 18 years old. * Subjects not diagnosed with UC, or other inflammatory, allergic, malignant or autoimmune diseases. * Women of childbearing age using contraceptive methods with an error rate \<1% per year. Examples of contraceptive methods whose error rate is \<1% per year are: 1. Intrauterine device (IUD). 2. Bilateral tubal occlusion. 3. Couple with vasectomy. 4. Sexual abstinence. Exclusion Criteria: EX VIVO STUDY IN PATIENTS WITH UC PATIENTS WITH UC: * Under 18 years old. * Immune-mediated disease, neoplasm or active infection. * Pregnancy or lactation. * Alcohol or drug abuse. * Ostomy. * Abdominal surgery in the last 6 months. * Colectomy. * Active infection with hepatitis B, C or HIV virus. * Medical history of thromboembolic events. * Treatment with anticoagulants, antiplatelets or other drugs that alter the coagulation. * Use of combined hormonal contraceptives or hormone replacement therapy. * Hereditary coagulation disorders. * Refusal to give consent for participation in the study. INDIVIDUALS WITHOUT UC: * Under 18 years of age. * Advanced chronic disease or any other pathology that prevents the monitoring of the protocol of this study. * Pregnancy or lactation. * Alcohol or drug abuse. * Ostomy. * Abdominal surgery in the last 6 months. * Colectomy. * Active infection with hepatitis B, C or HIV virus. * Medical history of thromboembolic events. * Treatment with anticoagulants, antiplatelets or other drugs that alter the coagulation. * Use of combined hormonal contraceptives or hormone replacement therapy. * Hereditary coagulation disorders. * Refusal to give consent for participation in the study. IN VIVO STUDY IN PATIENTS WITH UC PATIENTS WITH UC: * Under 18 years old. * Immune-mediated disease. * Neoplasm or active infection. * Pregnancy or lactation. * Alcohol or drug abuse. * Ostomy. * Colectomy. * Active infection with hepatitis B, C or HIV virus. * Indication of anti-TNFα or JAK-inhibitors treatment for a cause other than UC. * Have previously received a drug with the same mechanism of action (anti-TNFα or JAK-inhibitors) * Medical history of thromboembolic events. * Treatment with anticoagulants, antiplatelets or other drugs that alter the coagulation. * Use of combined hormonal contraceptives or hormone replacement therapy. * Hereditary coagulation disorders. * Refusal to give consent for participation in the study. INDIVIDUALS WITHOUT UC: * Under 18 years of age. * Advanced chronic disease or any other pathology that prevents the monitoring of the protocol of this study. * Pregnancy or lactation. * Alcohol or drug abuse. * Active infection with hepatitis B, C or HIV virus. * Finding of macroscopic alterations during the colonoscopy or finding of relevant inflammatory alterations in the biopsies obtained during the colonoscopy. * Treatment with immunomodulators, immunosuppressants, corticosteroids or other drugs that alter the immune system. * Medical history of thromboembolic events. * Treatment with anticoagulants, antiplatelets or other drugs that alter the coagulation. * Use of combined hormonal contraceptives or hormone replacement therapy. * Hereditary coagulation disorders. * Refusal to give consent for participation in the study. * Abdominal surgery in the last 6 months.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Hospital Universitario de La Princesa
Madrid, Madrid, 28006, Spain
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