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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-004105-28-IE

Enrollment

300

Registered

2006-02-10

Start date

2006-06-20

Completion date

Unknown

Last updated

2020-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC). MedDRA version: 8.0 Level: LLT Classification code 10045265

Interventions

Product Name: Visilizumab (Nuvion) Product Code: HuM291 Pharmaceutical Form: Solution for injection INN or Proposed INN: Visilizumab CAS Number: 219716-33-3 Current Sponsor code: HuM291 Other descrip

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Eligible subjects will be considered for inclusion in this study if they meet all of the following criteria: 1) Previous participation in an IVSR-UC visilizumab study. 2) Disease progression while enrolled in a previous visilizumab study, and subsequent treatment with salvage therapy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1) Unable to understand the purpose and risks of the study, or unwilling or unable to provide signed and dated informed consent. 2) For U.S. sites, unwilling or unable to provide authorization to use protected health information.

Design outcomes

Primary

Measure	Time frame
Secondary Objective: To assess the health-related quality of life and pharmacoeconomic outcomes of colectomy and other salvage therapies, and the response to salvage medications in subjects who received salvage therapy.;Main Objective: 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. Subjects will be grouped for exploratory analysis in this study based mainly on covariates of interest, such as the study drug they received and their outcomes in the previous studies. In particular, the following groups will be considered: 1) early visilizumab failures, ie, subjects who did not respond to treatment with visilizumab within 90 days after receipt of study drug, 2) early placebo failures, ie, subjects who did not have a response within 90 days after receipt of placebo, and 3) late treatment failures, ie, subjects who had disease relapse 90 or more days after receipt of visilizumab or placebo. ;Primary end point(s): The primary endpoint is the incidence of medically important events, including infections (opportunistic infections and those requiring hospitalization or parenteral therapies), malignancies, lymphoproliferative disorders, pericolectomy complications (up to 60 days after colectomy), and other surgeries, after an initiation of salvage therapy.	—

Measure

Time frame

Secondary Objective: To assess the health-related quality of life and pharmacoeconomic outcomes of colectomy and other salvage therapies, and the response to salvage medications in subjects who received salvage therapy.;Main Objective: 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. Subjects will be grouped for exploratory analysis in this study based mainly on covariates of interest, such as the study drug they received and their outcomes in the previous studies. In particular, the following groups will be considered: 1) early visilizumab failures, ie, subjects who did not respond to treatment with visilizumab within 90 days after receipt of study drug, 2) early placebo failures, ie, subjects who did not have a response within 90 days after receipt of placebo, and 3) late treatment failures, ie, subjects who had disease relapse 90 or more days after receipt of visilizumab or placebo. ;Primary end point(s): The primary endpoint is the incidence of medically important events, including infections (opportunistic infections and those requiring hospitalization or parenteral therapies), malignancies, lymphoproliferative disorders, pericolectomy complications (up to 60 days after colectomy), and other surgeries, after an initiation of salvage therapy.

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Countries

France, Germany, Greece, Hungary, Ireland, Netherlands, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026