What the trial was testing
The TRUE NORTH enrolled 877 patients with ulcerative colitis. The study was sponsored by Celgene and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was a large trial designed to confirm whether the treatment works well enough for wider use. Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
Fewer than 4% of patients had any cardiac side effects over three years of treatment.
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2024 · NCT02531126
These findings — that had any cardiac side effects over three years — were published in the Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association and represent the headline result of the study.
Researchers tracked outcomes across 877 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with ulcerative colitis, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
If you're taking ozanimod for ulcerative colitis, this study is reassuring: serious heart problems were very rare over three years. Your doctor may check your heart rate and blood pressure at the start of treatment and during follow-ups, but the pill was well-tolerated overall. This treatment is FDA-approved and available now.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open ulcerative colitis trials
Tailored Anti-Inflammatory (A-I) Diet for Americans With Ulcerative Colitis (UC)
The purpose of this study is to test the effect of an anti-inflammatory diet that incorporates native foods of the American diet on disease remission in American patients with Ulcerative Colitis (UC) and to identify biomarkers of response to dietary therapy.
Inflammatory Bowel Disease (IBD) Research Registry
Patients seen at the Center for Inflammatory Bowel Disease will be asked to provide their written informed consent (authorization) to allow their identifiable medical record information related to their Inflammatory Bowel Disease to be placed in Center's Research Registry for the purpose of facilitating retrospective research studies directed at Inflammatory Bowel Disease, and the identification and recruitment of potential, eligible subjects for participation in future research studies involving Inflammatory Bowel Disease. Information obtained from the Inflammatory Bowel Disease Registry will allow a better classification of disease and factors that influence the natural course of disease; which may lead to a better understanding of the pathogenesis of IBD and may permit the development of better therapies and the potential for preventive therapies.