Active — Not RecruitingNot Applicable

An Observational Prospective Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis

United States537 participantsStarted 2016-12-16

Plain-language summary

The purpose of this study is to describe the long-term safety risks in adult participants with moderate-to-severe ulcerative colitis who are treated with Simponi.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. The participant is currently receiving Simponi ,or
✓. The participant is continuing to receive Simponi after participation in an ulcerative colitis study, or
✓. The participant is scheduled to receive Simponi within 30 days after enrollment
✓. The participant is currently receiving thiopurines, having received at least 12 consecutive weeks of therapy prior to registry entry
✓. Participant must not be receiving other approved biologic agents, including Simponi, or any investigational agents at enrollment
✓. Participant may have received biologics other than Simponi or investigational agents prior to enrollment

What they're measuring

Long-term Safety: Participants with Adverse Events of Interest (AEIs) and Serious Adverse Events (AEs) Including Malignancies, Pregnancies, and Non-serious Malignancies

Timeframe: 6 years

Trial details

NCT IDNCT02808780

SponsorJanssen Biotech, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-12-10

View on ClinicalTrials.gov More Ulcerative Colitis trials