STopping Aminosalicylate Therapy in Inactive Crohn’s Disease (STATIC) Study: A Randomized, Open-label, Non-inferiority Trial

1st April 2019 - ongoing

Status: In Recruitment

Specialism: Lower GI.

Team: Dr Gordon Moran.

We are conducting a large definitive study to investigate whether mesalazine is effective for patients with Crohn’s Disease.

STATIC is a study that is looking at people who have been diagnosed with Crohn’s Disease (CD) in the past, who are taking a specific type of medication known as an amino salicylate (5-ASA), but whose disease is not flaring (is in remission).

5-ASAs are one of the most commonly prescribed classes of drugs for Crohn’s Disease worldwide. Generally, they are considered to be safe and inexpensive, though rare but serious side effects can occur. In a review of clinical trials that tested whether 5-ASAs are effective for the management of CD, there is considerable uncertainty as to whether or not the treatment is of any benefit in maintaining remission for patients with CD.

This research study will aim to answer the question of whether 5-ASAs should be continued in subjects with CD who are in remission.

If you participate in this study your health will be monitored over five visits by a physician, in a two-year period. Half of all participants will be asked to stop taking their current dose and brand of 5-ASAs, the other half will continue to take their existing dose and brand of 5-ASA. Monitoring your health will consist of vital signs, collection of blood, urine, and stool, as well as answering questions regarding your visits to healthcare professionals, and your quality of life.

The study is being conducted at the NIHR Biomedical Research Centre by Dr Gordon Moran.

You may be eligible to take part in this study if you are:

  • Aged 18 years or older
  • Have a diagnosis of Crohn’s Disease for at least 6 months
  • Your Crohn’s disease is under control
  • Currently taking an oral mesalazine for at least 6 months
  • Willing to stop taking your oral mesalazine

Please contact us if you are interested to receive further information

Research team:

Senior Research Nurse: Shellie Radford shellie.radford@nuh.nhs.uk

Study Coordinator: Natalie Horsepool natalie.horsepool@nottingham.ac.uk

https://www.static-trial.com

People
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dr-gordon-moran Dr Gordon Moran Dr Moran did his undergraduate medical training at University of Malta Medical School and was awarded an MD in 1999. He completed his basic postgraduate training at St. Luke's Hospital in Malta and gained membership of the Royal College of Physicians of…
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