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

Recruiting in Palo Alto (17 mi)

+133 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Janssen Biotech, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Janssen Biotech, Inc. Clinical Trial

Principal Investigator

Janssen Biotech, Inc.

Eligibility Criteria

Inclusion Criteria

Have moderate-to-severe ulcerative colitis of at least 3 months' duration prior to enrollment, confirmed by endoscopy at any time in the past

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

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