Status:
COMPLETED
A Dose-Escalation Study of MDX-1100 in Patients With Active Ulcerative Colitis
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a Phase I dose-escalation study of MDX-1100. patients with ulcerative colitis will be enrolled into one of four dose cohorts, to receive of MDX-1100 at 0.3, 1.0, 3.0 or 10mg/kg. Three to six p...
Detailed Description
The primary objectives of this study is to establish the safety and tolerability of single doses of MDX-1100 administered in dose-escalating cohorts to patients with active ulcerative colitis (UC). T...
Eligibility Criteria
Inclusion
- signed informed consent and HIPAA
- must be 18 years or older
- patients with active ulcerative colitis with a UCDAI greater than or equal to 4 and less than or equal to 9.
- certain medications initiated at specific schedules prior to study drug administration may be enrolled.
- must meet screening laboratory values
- women of childbearing potential must be using effective contraception for at least 1 month prior to study entry and agree to continue contraception for the duration of their participation in the study, and
- Sexually active male patients must use a barrier method of contraception during the course of the study.
Exclusion
- History of colectomy, partial colectomy, current ostomy, or pouchitis
- Presence of Cushing's Syndrome
- Toxic megacolon or fulminant disease likely to require colectomy
- Prior treatment with any monoclonal antibody or immunoglobulin-based fusion proteins 8 weeks or less prior to treatment with MDX-1100
- Any experimental treatment 4 weeks or less prior to treatment with MDX-1100
- Primary or secondary immunodeficiency
- Any history of malignancy, excluding adequately treated and cured basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ
- Active major psychiatric disease(stable depression receiving appropriate medical management will be permitted)
- Evidence of acute or chronic infection or neoplasm on Screening chest radiography
- Current treatment for TB or positive PPD without prophylaxis
- Herpes zoster 3 months or less prior to screening
- Clinically significant cardiac disease requiring medication, unstable angina, myocardial infarction within 6 months, or congestive heart failure
- Active infectious disease requiring i.v. antibiotics within the past 4 weeks or oral antibiotics at the time of enrollment
- Arrhythmia requiring active therapy, with the exception of clinically insignificant extrasystoles, or minor conduction abnormalities
- History of cerebrovascular disease requiring medication/treatment
- Anticoagulation therapy or a known bleeding disorder
- Seizure disorder requiring active therapy
- Known drug or alcohol abuse
- Positive tests for HIV, HBV, or HCV
- Pregnant or nursing
- Any underlying medical condition that in the Investigator's opinion will make the administration of study drug hazardous to the patient or would obscure the interpretation of adverse events, or
- Inability or unwillingness to return for Follow-up visits
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00295282
Start Date
January 1 2006
End Date
January 1 2008
Last Update
April 23 2010
Active Locations (5)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
DMI Health Care Group, Inc.
Largo, Florida, United States, 33773
3
Metropolitan Gastroenterology Group, PC
Chevy Chase, Maryland, United States, 20815
4
University of Medicine and Dentistry of New Jersery (UMDNJ)
New Brunswick, New Jersey, United States, 08903