An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis

Phase 2

• Conditions: Chronic colon infection; Ulcerative colitis; 10017969; 10003816

• Registration Number: NL-OMON30550
• Lead Sponsor: PDL Biopharma Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 27

Inclusion Criteria

-Previous participation in a visilizumab study of IVSR-UC.
-Disease progression while enrolled in a previous visilizumab study, and subsequent treatment with salvage therapy (see Definitions).

Exclusion Criteria

Unable to understand the purpose and risks of the study, or unwilling or unable to provide a signed and dated informed consent.
For U.S. sites, unwilling or unable to provide authorization to use protected health information.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The incidence of medically important events including infections (opportunistic<br /><br>infections and those requiring hospitalization or parenteral therapies),<br /><br>malignancies, lymphoproliferative disorders, pericolectomy complications (up to<br /><br>60 days postcolectomy), and other surgeries, after the initiation of salvage<br /><br>therapy.</p><br>