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

Running, not enrolling

Conditions studied: Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT02808780

Run by

Janssen Biotech, Inc.

People needed

535

Starts

2016-12-16

Expected to finish

2027-03-11

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have moderate-to-severe ulcerative colitis of at least 3 months' duration prior to enrollment, confirmed by endoscopy at any time in the past
• For enrollment into the Simponi-exposed cohort meets one of the following:
• 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
• For Thiopurine cohort:
• 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

You may not qualify if…

• Participants who cannot be treated with Simponi or thiopurines
• Participants with a previous diagnosis of lymphoma or hematologic malignancy at any time prior to enrollment
• Participants currently receiving an investigational or biologic agent other than Simponi
• Participants with any condition for which, in the opinion of the investigator, participation in the registry would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments

Where it is running

• Study site — Rialto, California, United States
• Study site — Ventura, California, United States
• Study site — Coral Gables, Florida, United States
• Study site — Fort Myers, Florida, United States
• Study site — Lake Worth, Florida, United States
• Study site — Lauderdale Lakes, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Suwanee, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Sylvania, Ohio, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Lansdowne Town Center, Virginia, United States
• Study site — Salzburg, Austria
• Study site — Sankt Poelten Noe, Austria
• Study site — Vienna, Austria
• Study site — New Westminster, British Columbia, Canada
• Study site — Vancouver, British Columbia, Canada
• Study site — Oshawa, Ontario, Canada
• Study site — Ottawa, Ontario, Canada
• Study site — Pilsen, Czechia
• Study site — Clermont-Ferrand, France
• Study site — Murrieta, California, United States

Full record on ClinicalTrials.gov

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