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An Early Access Program For Ustekinumab In Participants With Moderately To Severely Active Crohn's Disease

Crohn Disease Clinical Trial

Official title:
An Early Access Program for Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease

Clinical Trial Summary

The purpose of this program is to provide early access to ustekinumab where it is commercially unavailable for the treatment of participants with moderately to severely active Crohn's disease who have failed treatment with conventional Crohn's disease therapy (example, immunomodulators or corticosteroids) and Tumor Necrosis Factor alpha (TNF alpha) antagonist therapy (e.g., infliximab, adalimumab, certolizumab pegol, or their biosimilars), or who are intolerant to, or have a contraindication to these treatments. During the course of this early access program (EAP), through the reporting of serious adverse events (SAEs) and non-serious adverse drug reactions (ADRs) by participating physicians, information on the safety and tolerability of ustekinumab will be captured.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03362736
Study type Expanded Access
Source Janssen Research & Development, LLC
Contact
Status No longer available
Phase
View Details
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