A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of rhuMAb Beta7 in Patients With Ulcerative Colitis

Completed · Phase 1 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

This is a randomized , double-blind, placebo-controlled study of approximately 70 patients with ulcerative colitis.

Key facts

Study ID

NCT00694980

Run by

Genentech, Inc.

People needed

48

Starts

2008-09-01

Expected to finish

2012-09-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Anniston, Alabama, United States
• Study site — San Francisco, California, United States
• Study site — Gainesville, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Lexington, Kentucky, United States
• Study site — Rochester, Minnesota, United States
• Study site — Great Neck, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Leuven, Belgium
• Study site — Calgary, Alberta, Canada
• Study site — Edmonton, Alberta, Canada
• Study site — Vancouver, British Columbia, Canada
• Study site — Victoria, British Columbia, Canada
• Study site — London, Ontario, Canada
• Study site — Montreal, Quebec, Canada
• Study site — Berlin, Germany
• Study site — Frankfurt, Germany
• Study site — Kiel, Germany
• Study site — Regensburg, Germany
• Study site — Ulm, Germany
• Study site — Leiden, Netherlands
• Study site — Maastricht, Netherlands
• Study site — Nijmegen, Netherlands
• Study site — Utrecht, Netherlands
• Study site — Bristol, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.