Status:
COMPLETED
A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of rhuMAb Beta7 in Patients With Ulcerative Colitis
Lead Sponsor:
Genentech, Inc.
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This is a randomized , double-blind, placebo-controlled study of approximately 70 patients with ulcerative colitis.
Eligibility Criteria
Inclusion
- Able and willing to provide written informed consent
- 18-70 years of age
- Males and females with reproductive potential: Willing to use a reliable method of contraception
- Diagnosis of ulcerative colitis
- Eligible to receive biologic therapy
- Disease duration of \>=12 weeks
Exclusion
- Requirement for hospitalization due to severity of ulcerative colitis
- Moderate to severe anemia
- Any manifestation of ulcerative colitis or other conditions likely to require, in the investigator's judgment, treatment with \>20 mg/day of prednisone, or prednisone equivalent, during the course of the study
- Pregnant or lactating
- Lack of peripheral venous access
- Inability to comply with study protocol
- History or presence of contraindicated diseases
- Congenital immune deficiency
- Active or prior infection with HIV or hepatitis B or C
- History of severe systemic bacterial, fungal, viral, or parasitic infections
- History of any other opportunistic infections within 12 weeks prior to initiation of study treatment
- Received a live attenuated vaccine within 4 weeks prior to screening
- Hospitalized within 4 weeks prior to screening
- Received any contraindicated therapy within 12 weeks prior to screening
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00694980
Start Date
September 1 2008
End Date
September 1 2012
Last Update
November 2 2016
Active Locations (30)
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1
Anniston, Alabama, United States, 36207
2
San Francisco, California, United States, 94115
3
Gainesville, Florida, United States, 32610
4
Atlanta, Georgia, United States, 30308