Trial intelligence / Profile preview

PRECiSE 4: Certolizumab Pegol Re-exposure in Crohn's Disease

NCT00160706Phase 3

Key facts

Status: Completed
Start: Feb 2004
Primary completion: May 2012
Countries: 24
Sponsor: UCB
Modality: Antibody Fragments, Polymer-based Nanoparticles

Drugs: certolizumab pegol
Conditions: Crohn's disease

Overview

Phase 3, open-label, single-arm trial of certolizumab pegol in Crohn's disease, sponsored by UCB. Primary endpoints: Percentage of Subjects With at Least One Adverse Event up to 84 months and Percentage of Subjects With at Least One Serious Adverse Event up to 84 months. Started Feb 2004; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

Certolizumab Pegol
Certolizumab Pegol 400 mg SC induction and maintenance

Endpoints

Primary

Percentage of Subjects With at Least One Adverse EventUp to 84 months
Percentage of Subjects With at Least One Serious Adverse EventUp to 84 months

Secondary

Percentage of Subjects Achieving Harvey Bradshaw Index RemissionWeek 362
Percentage of Subjects in Harvey Bradshaw Index ResponseWeek 362
Plasma Concentration of Certolizumab PegolWeek 362
Percentage of Subjects With Positive Anti-CZP Antibody StatusUp to 90 months
C-Reactive Protein LevelWeek 362
Fecal Calprotectin LevelWeek 256

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