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Sponsored by: |
Medarex |
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Information provided by: | Medarex |
ClinicalTrials.gov Identifier: | NCT00656890 |
The purpose of this study is to determine the safety and tolerability of the MDX-1100 regimen in subjects with active Ulcerative colitis(UC) and determine the response rate at day 57 in patients administered MDX-1100.
Condition | Intervention | Phase |
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Ulcerative Colitis |
Biological: sterile saline for injection Biological: MDX-1100 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2, Multi-Dose, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study of MDX-1100 (Anti-CXCL10 Human Monoclonal Antibody)in Subjects With Active Ulcerative Colitis |
Estimated Enrollment: | 106 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2: Placebo Comparator
sterile saline for injection
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Biological: sterile saline for injection
10mg/kg/dose sterile saline injected every other week for a total of 4 doses
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1: Experimental
MDX-1100 for injection
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Biological: MDX-1100
10mg/kg/dose MDX-1100 injected every other week for a total of 4 doses
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This is a Phase2, double-blind, placebo-controilled, randomized, multicenter, multi-dose study of MDX-1100 (anti-CXCL10 human monoclonal antibody) in subjects with active UC experiencing flare. All subjects will have active disease while on a 5-ASA containing medication and are either on stable doses of corticosteroids and/or azathioprine or 6-mercaptopurine, or who have previously been on these medications but could not tolerate them. Flare is defined as a Mayo score of 6 to 10 with moderate to severe disease activity on endoscopy (Mayo endoscopic subscore of at least 2) within 2 weeks of receiving study drug administa=ration. Doses of permitted concomitant medications (corticosteroids, azathioprine (AZA), 6-mercaptopurine (6-MP), and 5-aminosalicylates (5-ASA) containing compounds) should remain constant during the course of the study.
Subjects will be randomized to receive placebo or MDX-1100 by intravenous (i.v.) infusion at 10 mg/kg on Days 1, 15, 29, and 43.All subjects will be seen in the clinic at regular intervals up to Day 85 for safety, efficacy, pharmacokinetic, and/or pharmacodynamic assessments. All subjects will be contacted 70 days after the last dose of study drug.
Assessment of safety will be determined by vital sign measurements, clinical laboratory tests, physical examinations, immunogenicity assessments, chest x-ray, electrocardiograms, and the incidence and severity of treatment emergent adverse events.
The primary clinical assessment of activity will be determined by the change in Mayo score at Day 57 compared with Screening. Secondary endpoints include determination of remission rate by the mayo score at Day 57, evaluation of mucosal healing and change from baseline in the IBDQ score.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects on the following medications may be enrolled into the study if the medications were according to the following schedules prior to study drug administration and if no changes are anticipated during the study;
Exclusion Criteria:
Contact: James Bainbridge | 908.479.2364 | jbainbridge@medarex.com |
Contact: Einav Leberknight | 908.479.2570 | eleberknight@medarex.com |
United States, Florida | |
Advanced Medical Research Center | Recruiting |
Port Orange, Florida, United States, 32127 | |
Principal Investigator: Ammar Hemaidan, MD | |
United States, Maryland | |
Chevy Chase Clinical Research | Recruiting |
Chevy Chase, Maryland, United States, 20815 | |
Contact: Jennifer Bell 301-652-5520 | |
Principal Investigator: Robert Hardi, MD | |
United States, Missouri | |
Washington University School of Medicine | Recruiting |
St. Louis, Missouri, United States, 63110 | |
Contact: Caroline Vemulapalli 314-362-9093 | |
Principal Investigator: Christian D Stone, MD | |
United States, New York | |
Mount Sinai School of Medicine | Recruiting |
New York, New York, United States, 10029 | |
Contact: Bradford Bernert 212-659-8375 | |
Principal Investigator: Lloyd F Mayer, MD | |
United States, Ohio | |
Dayton Science Institute | Recruiting |
Dayton, Ohio, United States, 45415 | |
Contact: Gigi Guerrero 937-293-4424 ext 6153 | |
Principal Investigator: Teressa J Patrick, MD |
Study Director: | Michael Yellin, MD | Medarex |
Responsible Party: | Medarex, Inc ( Medarex, Inc ) |
Study ID Numbers: | MDX1100-06 |
Study First Received: | April 4, 2008 |
Last Updated: | October 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00656890 |
Health Authority: | United States: Food and Drug Administration |
ulcerative colitis, rectal bleeding |
Gastrointestinal Diseases Ulcer Colonic Diseases Inflammatory Bowel Diseases Colitis, Ulcerative Hemorrhage Intestinal Diseases |
Antibodies, Monoclonal Antibodies Digestive System Diseases Gastroenteritis Colitis Immunoglobulins |
Pathologic Processes |