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Basiliximab Maintenance in Ulcerative Colitis

NCT01061996 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2010-02-04

No results posted yet for this study

Summary

Primary Objective Safety: assess the safety of basiliximab 40 mg, given every 4 weeks, in subjects with ulcerative colitis who completed previous basiliximab studies.

Secondary Objectives: evaluate the efficacy and assess the immunogenicity of this multiple-dose maintenance regimen in this population

Conditions

Interventions

DRUG

Basiliximab

Study Drug: basiliximab 40 mg, given as a short intravenous infusion Dosing Schedule: once every 4 weeks Concomitant Therapy: Oral corticosteroids (prednisone or equivalent) will be tapered during the first few months of the study participation Duration of Study Participation: The duration of individual study participation will vary.

Sponsors & Collaborators

  • Cerimon Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Shaily J. Reichert · Cerimon Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01061996 on ClinicalTrials.gov