Most Adults With Moderate-to-Severe Ulcerative Colitis Ineligible for RCTs

THURSDAY, Aug. 27, 2026 (HealthDay News) — More than half of real-world adult patients with moderate-to-severe ulcerative colitis (UC) are ineligible for current randomized controlled trials (RCTs), according to a study published online Aug. 4 in Crohn”s & Colitis 360.

Sandra Elmasry, M.D., from the Mayo Clinic Arizona in Scottsdale, and colleagues conducted a retrospective cohort study involving adults with moderate-to-severe UC seen between January 2022 and February 2023 to examine contemporary clinical trial eligibility in a tertiary care setting. To determine patient eligibility, inclusion and exclusion criteria for seven phase 3 RCTs conducted between 2012 and 2022 were applied.

The researchers found that only 42.7 percent of the 150 patients were eligible for at least one RCT. Current or prior medication use was the most common exclusion factor, followed by anemia, dysplasia, and extent of disease. No significant difference was seen in trial eligibility based on age, gender, or disease duration.

“Compared to results from 2012, our study findings demonstrate potential improvement with 42.7 percent of patients now considered trial-eligible for at least one study although there remains considerable potential for improvement to include a broader range of patients,” the authors write.

One author disclosed ties to the biopharmaceutical industry.

Abstract/Full Text