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Effect of Tofacitinib on coagulation and platelet function, and its role in thromboembolic events
EU CTIS ID: 2024-518434-83-01
What this study is testing
Evaluate the effect of tofacitinib on platelet function and coagulation in patients with ulcerative colitis.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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).
- 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.
You likely can't join if
- Under 18 years old.
- Pregnancy or lactation.
- Alcohol or drug abuse.
- Ostomy.
- Colectomy.
- Active infection with hepatitis B, C or HIV virus.
See the full eligibility criteria
- 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).
- 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.
- Under 18 years old.
- 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.
- abdominal surgery in the last 6 months
- 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.
- Immune-mediated disease.
- Neoplasm or active infection.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.