A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of rhuMAb Beta7 in Patients With Ulcerative Colitis
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00694980 |
Recruitment Status :
Completed
First Posted : June 11, 2008
Last Update Posted : November 2, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ulcerative Colitis | Drug: placebo Drug: rhuMAb Beta7 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 48 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Phase I, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Intravenous and Subcutaneous rhuMAb Beta7 Administered in a Single-Dose, Dose-Escalation Stage Followed by a Multidose, Parallel-Treatment Stage in Patients With Ulcerative Colitis |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | September 2011 |
Actual Study Completion Date : | September 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Drug: placebo
Intravenous and subcutaneous escalating doses Drug: rhuMAb Beta7 Intravenous and subcutaneous escalating doses |
- Incidence and nature of laboratory abnormalities [ Time Frame: Through study completion or early study discontinuation ]
- Incidence, nature, and severity of adverse events [ Time Frame: Through study completion or early study discontinuation ]
- PK profile and parameters [ Time Frame: Through study completion or early study discontinuation ]
- Incidence of antibodies directed against rhuMAb Beta7 [ Time Frame: Through study completion or early study discontinuation ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00694980
United States, Alabama | |
Anniston, Alabama, United States, 36207 | |
United States, California | |
San Francisco, California, United States, 94115 | |
United States, Florida | |
Gainesville, Florida, United States, 32610 | |
United States, Georgia | |
Atlanta, Georgia, United States, 30308 | |
United States, Kentucky | |
Lexington, Kentucky, United States, 40536 | |
United States, Minnesota | |
Rochester, Minnesota, United States, 55905 | |
United States, New York | |
Great Neck, New York, United States, 11021 | |
United States, North Carolina | |
Chapel Hill, North Carolina, United States, 27599 | |
Belgium | |
Leuven, Belgium, 3000 | |
Canada, Alberta | |
Calgary, Alberta, Canada, T2N 2T9 | |
Edmonton, Alberta, Canada, T6G 2X8 | |
Canada, British Columbia | |
Vancouver, British Columbia, Canada, V6Z 2K5 | |
Victoria, British Columbia, Canada, V8V 3P9 | |
Canada, Ontario | |
London, Ontario, Canada, N6A 4L6 | |
Canada, Quebec | |
Montreal, Quebec, Canada, H1T 2M4 | |
Germany | |
Berlin, Germany, 13353 | |
Frankfurt, Germany, 60431 | |
Kiel, Germany, 24105 | |
Regensburg, Germany, 93053 | |
Ulm, Germany, 89081 | |
Netherlands | |
Leiden, Netherlands, 2333 ZA | |
Maastricht, Netherlands, 6229 HX | |
Nijmegen, Netherlands, 6525 GA | |
Utrecht, Netherlands, 3584 CX | |
United Kingdom | |
Bristol, United Kingdom, BS2 8HW | |
London, United Kingdom, SE1 7EH | |
London, United Kingdom, SW10 9NH | |
London, United Kingdom, W12 0HS | |
Newcastle upon Tyne, United Kingdom, NE1 4LP | |
Nottingham, United Kingdom, NG7 2UH |
Study Director: | Clinical Trials | Genentech, Inc. |
Responsible Party: | Genentech, Inc. |
ClinicalTrials.gov Identifier: | NCT00694980 |
Other Study ID Numbers: |
ABS4262g GA00930 ( Other Identifier: Hoffmann-La Roche ) |
First Posted: | June 11, 2008 Key Record Dates |
Last Update Posted: | November 2, 2016 |
Last Verified: | November 2016 |
UC Ulcerative Colitis |
Colitis Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases |
Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases rhuMAb Beta7 Gastrointestinal Agents Immunologic Factors Physiological Effects of Drugs |