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

PDL BioPharma

Status: Terminated

Conditions: Ulcerative Colitis

Treatments: Drug: Visilizumab (Nuvion®; HuM291)

Study type: Observational

Funder types: Industry

Identifiers

NCT00355901

291-420

Details and patient eligibility

About

To assess the effects of visilizumab on the safety of subsequent salvage therapies in subjects who experienced disease progression in a previous visilizumab study and subsequently received salvage therapy.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

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.