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PROFILE - personalised medicine in Crohn's disease

Crohn’s disease affects everyone differently. While some people have mild symptoms, others experience severe flare-ups that need strong medication early on. Currently, doctors cannot easily predict how severe someone’s condition will be. The PROFILE study aims to change this using a new blood test called a biomarker. This test looks at patterns in your blood to predict how your Crohn's might behave. Participants are adults aged 16 to 80 who have been diagnosed with Crohn’s within the past three months. Everyone in the study receives approved, active medication; no dummy treatments (placebos) are used. Half receive early intensive treatment with regular medicine infusions and tablets, while the other half follow standard NHS care where treatment is increased if needed. Researchers want to see if using the blood test to guide these decisions helps people stay well for longer.

Em resumo

Status
Concluído
Patrocinador
Fundação NHS dos Hospitais da Universidade de Cambridge
Meta de inscrição
400
Iniciar
01 Dec 2017
Conclusão estimada
15 Dez 2021
Doença de Crohn

Sobre o que é este estudo?

Crohn’s disease is a lifelong condition that causes painful swelling and inflammation in parts of the digestive system. Because it affects every person differently, finding the right medication can sometimes take months of trial and error. Some people manage well with mild treatments, while others need stronger medicines straight away to prevent long-term bowel damage.

The PROFILE trial was set up to find out if a simple blood test can take the guesswork out of treatment. This test looks at specific markers in your blood, known as biomarkers. Researchers believe these markers can show right at diagnosis whether your Crohn’s is likely to be mild or severe. If doctors know this early on, they can give each person the treatment that suits them best from day one.

Everyone who takes part in the study receives well-tested, approved NHS treatments for Crohn’s disease. Participants are split into two groups. One group starts on an intensive course of medicine (an intravenous drip called infliximab along with daily tablets). The other group receives the current standard care, where stronger medicines are introduced step-by-step only if symptoms return or get worse.

By comparing these groups, the study hopes to show whether personalised care guided by a blood test leads to fewer flare-ups, fewer hospital visits, and a better quality of life. The findings could change how newly diagnosed Crohn's disease is treated across the NHS.

Pontos principais

  • The PROFILE trial tests whether a blood test can help personalise Crohn's disease treatment.
  • It is designed for people aged 16 to 80 who were diagnosed with Crohn’s within the last three months.
  • All participants receive active, approved medications; no placebos are used.
  • Participants are followed closely by specialist hospital teams for around one year.
  • Joining is completely voluntary, and you can withdraw at any time without harming your NHS care.

Quem pode ser elegível?

This trial is open to people aged between 16 and 80 who have received a firm diagnosis of Crohn’s disease within the last three months. To be eligible, your Crohn’s must be currently active, which doctors check through regular blood or stool tests and camera examinations of your bowel. You must also be new to advanced Crohn's treatments, meaning you have not yet taken biologic drugs or immune-modifying tablets.

The study is not suitable for people with other forms of bowel disease, such as ulcerative colitis. It also excludes people who have severe complications needing urgent surgery, such as a major blockage in the bowel or deep infections (abscesses).

For safety reasons, you cannot join if you have a history of serious conditions like tuberculosis, hepatitis B or C, or cancer. The study is also not suitable for anyone who is currently pregnant or breastfeeding.

Este estudo pode ser adequado para você?

Responda a estas perguntas rápidas para ver se você pode ser elegível. Este é apenas um guia — a decisão final é da equipe de pesquisa.

  1. I was diagnosed with Crohn’s disease within the last 3 months.
  2. I am between 16 and 80 years old.
  3. I currently have active symptoms or inflammation from my Crohn’s.
  4. I have not previously taken biologic drugs or immune-modifying tablets.
  5. I am not pregnant or breastfeeding.
Responda a todas as perguntas para ver o seu resultado.

O que envolve a participação?

If you decide to join the study, you will be placed into one of two treatment groups by chance (randomly). If you are in the first group, you will receive an intensive treatment course involving about eight hospital visits over a year to receive infliximab through a drip, alongside daily tablets. If you are in the second group, you will start with standard NHS medications, and your doctor will step up your treatment if your symptoms do not improve. Throughout the year, you will attend regular hospital appointments for blood tests, stool checks, and symptom reviews so researchers can track how well your bowel is healing. Your total involvement lasts around one year.

Riscos e benefícios potenciais

A major benefit of taking part is that you will receive close monitoring from specialist bowel teams and prompt, active treatment for your Crohn’s disease without any placebos. However, like all medical treatments, the study medicines can cause side effects such as mild reactions during infusions or an increased risk of infections. Your care team will monitor you closely to catch and manage any problems early. Taking part is entirely voluntary, and you are free to leave the trial at any time without giving a reason and without it affecting your standard NHS care.

Locations (40)

  • Addenbrookes Hospital
    Apenas cidade
    Cambridge, Inglaterra
  • Barts and Royal London Hospital
    Apenas cidade
    London, England
  • Bedford Hospital
    Aproximado
    Bedford, England
  • Hospital Memorial de Darlington
    Aproximado
    Darlington, England
  • Derriford Hospital, Plymouth
    Aproximado
    Plymouth, England
  • Epsom General Hospital
    Não verificado
    Epsom, England
  • Glasgow Royal Infirmary
    Não verificado
    Glasgow, Scotland
  • New Victoria Hospital, Glasgow
    Não verificado
    Glasgow, Scotland
  • Gloucestershire Royal Hospital
    Não verificado
    Gloucester, England
  • Guy's and St Thomas' Hospital
    Não verificado
    London, England
  • Hull Royal Infirmary
    Não verificado
    Hull, England
  • James Paget Hospital, Great Yarmouth
    Não verificado
    Great Yarmouth, England

Perguntas frequentes

Will I receive a dummy treatment (placebo)?

No. There are no placebos in this study. Every participant receives active, approved medications to treat their Crohn’s disease.

What is a biomarker?

A biomarker is a measurable biological sign found in the body, such as a specific protein or gene pattern in your blood. In this study, it acts like a clue to predict how active your Crohn's might be.

Are the medications new or experimental?

No. The medicines used in this study, including infliximab and immune-modifying tablets, are already widely used and approved for treating Crohn’s disease in the NHS.

Quanto tempo estarei no estudo?

Active involvement in the trial lasts for approximately one year, during which your treatment and health will be closely followed by the hospital team.

What happens if my Crohn’s gets worse during the study?

Your safety comes first. If your symptoms worsen at any point, your doctor can adjust your medication or change your treatment plan immediately.

Como saber mais

Francis Dowling

francis.dowling@nhs.net +44 (0)1223 254 666 Registro oficial do julgamento

Sempre consulte seu médico ou especialista antes de decidir participar de um estudo.

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