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RecruitingTherapeutic use (Phase IV)Interventional

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

Ulcerative colitis is a long-term condition causing gut inflammation. People with active inflammation have a slightly higher chance of developing blood clots. This clinical study aims to understand how common colitis treatments affect blood clotting. Researchers are focusing on tofacitinib and anti-TNF medicines like infliximab, adalimumab, and golimumab. They want to see how these medicines influence platelets, which are tiny blood cells that stick together to form clots. The study involves adults with ulcerative colitis and healthy volunteers. The team will test blood samples in the laboratory before and after patients start their prescribed treatment. Doctors will also check how the lining of the bowel is healing using an endoscopy camera test after three months. The findings will help doctors better understand medicine safety and improve care for people living with bowel conditions.

At a glance

Status
Recruiting
Phase
Therapeutic use (Phase IV)
Sponsor
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa
Enrolment target
60
Start
20 Nov 2024

What is this study about?

Ulcerative colitis causes inflammation and swelling in the large bowel. When the gut is inflamed, the body's immune system is overactive. This inflammation can sometimes make the blood stickier, increasing the risk of unwanted blood clots. Platelets are the small cells in our bloodstream responsible for clotting, and they can become unusually active during a colitis flare-up.

Doctors frequently treat moderate to severe ulcerative colitis with medicines like tofacitinib or anti-TNF therapies (such as infliximab, adalimumab, or golimumab). While these treatments are known to calm inflammation and heal the bowel, scientists want to learn more about how they affect clotting cells. This study explores whether these medicines alter platelet behaviour and whether this helps lower the risk of clots.

During the study, researchers will collect blood samples from patients who have active colitis, patients whose colitis is quiet, and healthy volunteers. For patients starting a new treatment, blood will be tested before and after taking the medicine. Doctors will also perform a camera check (endoscopy) after three months to see if the gut lining has healed.

By comparing these results, doctors hope to gain valuable insights into how these therapies protect both the gut and the bloodstream. The information gathered may help healthcare teams choose the safest, most effective medicines for people with bowel diseases in the future.

Key takeaways

  • The study explores how ulcerative colitis medicines affect blood platelets and clotting.
  • Medicines being studied include tofacitinib and anti-TNF therapies like infliximab, adalimumab, and golimumab.
  • Adults with ulcerative colitis and healthy volunteers aged 18 and over can take part.
  • Participation involves routine blood tests and an endoscopy check at three months.
  • Taking part is voluntary and will not disrupt your regular healthcare.

Who may be eligible?

This study is open to adults aged 18 and older. It welcomes people diagnosed with ulcerative colitis, whether their condition is currently active or settled and quiet.

To take part as a patient starting treatment, your specialist will need to be planning treatment with tofacitinib or an anti-TNF medicine (infliximab, adalimumab, or golimumab). Healthy adults without inflammatory bowel disease can also join as a comparison group to provide baseline blood samples.

Your healthcare team will check your medical history to make sure you can safely join the study and undergo standard blood tests and routine clinic visits.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. I am aged 18 or older.
  2. I have been diagnosed with ulcerative colitis, OR I am a healthy volunteer.
  3. If I have colitis, my doctor is considering tofacitinib or an anti-TNF treatment for me.
  4. I am willing to provide blood samples for laboratory testing.
  5. I am willing to have a camera check (endoscopy) after three months if recommended.
Answer every question to see your result.

What does participation involve?

Taking part in this study lasts around three months. If you join as a patient starting treatment, you will take your prescribed medication as advised by your specialist doctor. You will have regular clinic visits where the team will take blood samples to measure how your platelets react. You will give blood before starting your new medicine and again after being on it for a set period. At the three-month mark, you will have a camera check of your bowel (an endoscopy) to see how well your gut lining has responded to the treatment. Healthy volunteers will only need to provide a blood sample.

Potential risks and benefits

Taking part may not directly improve your health, but you will be closely monitored by a specialist team, and your bowel healing will be carefully checked. The main physical discomforts involve routine blood tests, which can cause brief stinging or minor bruising, and the three-month endoscopy, which can cause temporary bloating or cramping. Taking part is completely voluntary. You can choose to stop participating at any point without it affecting your standard NHS medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • —
    Unverified
    Spain

Common questions

Are the study medicines new or experimental?

No. The medicines used in this study—tofacitinib and anti-TNF therapies—are already approved and routinely prescribed for treating ulcerative colitis.

Why are healthy people needed for this study?

Healthy volunteers provide blood samples so scientists can compare normal platelet behaviour with the platelets of people who have bowel inflammation.

Will taking part cost me anything?

No, taking part in clinical research does not cost you anything, and your usual NHS care will continue as normal.

What is an endoscopy?

An endoscopy is a routine medical test where a doctor passes a thin, flexible tube with a camera into your bowel to look at the lining and check for inflammation.

Can I leave the study if I change my mind?

Yes. You have the right to withdraw from the study at any time, for any reason, without your medical care being affected.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Effect of Tofacitinib on coagulation and platelet function, …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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