What the trial was testing
The U-EXCEL enrolled 526 patients with crohn's disease. The study was sponsored by AbbVie 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
About 50% reached clinical remission at 12 weeks — roughly twice the placebo rate.
New England Journal of Medicine · 2023 · NCT03345849
These findings — that of patients in clinical remission at 12 weeks on upadacitinib vs. placebo — were published in the New England Journal of Medicine and represent the headline result of the study.
Researchers tracked outcomes across 526 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 crohn's disease, 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
Upadacitinib (Rinvoq) is FDA-approved for moderately to severely active Crohn's disease in adults who haven't responded to other treatments and available now. It is taken as a once-daily pill — no injections or infusions. Side effects can include increased infection risk and lab changes; regular monitoring is required. Ask your gastroenterologist whether it fits.
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 crohn's disease trials
Combined Immunosuppression for Pediatric Crohn's Disease
This is a randomized controlled trial to compare the efficacy and safety of infliximab and immunosuppressives therapy alone or in combination for pediatric Crohn's disease.
Pregnancy and Inflammatory Bowel Disease
Inflammatory Bowel disease, including Crohn's disease and Ulcerative Colitis, are chronic diseases. Diagnosis is most often done in women of childbearing age. IBD can have and increase the risk of intrauterine growth retardation, preterm birth… Conversely, pregnancy can have an impact on IBD activity during pregnancy. Moreover, IBD course can be influence in post-partum. The investigators will explore IBD course on 945 patients from the EPIMAD register. The investigators will cross the data on the IBD with data on pregnancy, postpartum but also breastfeeding. The principal aim of this study is to assess the number of flares during pregnancy.