Ulcerative colitis drugs put under the microscope for hidden clot risk

NCT ID NCT05313620

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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

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

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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