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New treatment option for Ulcerative Colitis
Official title Effect of Tofacitinib on Coagulation and Platelet Function, and Its Role in Thromboembolic Events
ClinicalTrials.gov ID: NCT05313620
What this study is testing
What is Tofacitinib?
Tofacitinib is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for ulcerative colitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Post-authorization, prospective and unicenter clinical trial, in which patients with UC will be included. The treatment with anti-TNFα (infliximab, adalimumab or golimumab) or JAK-inhibitors (tofacitinib) will be initiated by clinical practice and the choice will be made at the discretion of the investigator at the center where the patients will be recruited (Hospital Universitario de La Princesa).
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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 ≥...
You likely can't join if
- 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.
See the full eligibility criteria
Who can join
- 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:
- Intrauterine device (IUD).
- Bilateral tubal occlusion.
- Couple with vasectomy.
- Sexual abstinence. INDIVIDUALS WITHOUT UC:
- Over 18 years old.
- people 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:
- Intrauterine device (IUD).
- Bilateral tubal occlusion.
- Couple with vasectomy.
- 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...
- 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:
- Intrauterine device (IUD).
- Bilateral tubal occlusion.
- Couple with vasectomy.
- Sexual abstinence. INDIVIDUALS WITHOUT UC:
- Over 18 years old.
- people 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:
- Intrauterine device (IUD).
- Bilateral tubal occlusion.
- Couple with vasectomy.
- Sexual abstinence.
What rules you out
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Madrid, Madrid, Spain
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 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madrid, Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.