Cure8 trial brief
Long-term safety data on biologics and thiopurines are important for people with ulcerative colitis because they help patients and clinicians weigh risks (including malignancies and pregnancy-related outcomes) when choosing or continuing treatments.
Adult patients with moderate-to-severe ulcerative colitis, people currently taking or considering golimumab (Simponi) or thiopurines, gastroenterologists, and researchers studying IBD medication safety.
This ClinicalTrials.gov record describes an observational registry sponsored by Janssen to follow about 535 adults with moderate-to-severe ulcerative colitis. There are two cohorts: patients exposed to Simponi (golimumab) and patients receiving thiopurines (at least 12 weeks of therapy).
Participants in the Simponi arm may be on Simponi alone or with thiopurines but must not be on other biologics at enrollment. The registry will collect and report serious adverse events, adverse events of interest (including lymphoma and other malignancies), pregnancies, and non-serious malignancies over a planned follow-up of up to 6 years.
Enrollment and design details: Minimum age is 18, planned enrollment ~535, and multiple U.S. sites are listed. This is observational (non-interventional) and is labeled Active, Not Recruiting in the record, meaning the registry activities are ongoing but not enrolling new participants.
This is a registry trial record (observational) on ClinicalTrials.gov sponsored by the drug manufacturer. It describes planned data collection and follow-up but is not a report of results. Any safety signals would need peer-reviewed publication or regulatory communication for clinical decision-making.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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