Trial Information

Summary: The study is designed to determine how safe and effective MDX 1100 (fully human antibody) is when given to patients with active ulcerative colitis.

The study will be conducted at more than 1 center, and up to 24 patients will participate. The primary purpose of the study is to determine the safest dose of MDX 1100. Another purpose of the study is to determine the effectiveness of MDX 1100 in Ulcerative Colitis patients. In order to do this it is necessary for small groups of patients (between 3-6 patients) to receive a single dose of MDX 1100.

Patients in the first group will receive the lowest dose of MDX 1100 which is 0.3 mg/kg. Depending on the side effects that are seen at each consecutive dose level, other groups of patients may or may not receive the higher doses of MDX 1100 which are 1mg/kg, 3mg/kg, and 10mg/kg (the highest dose)

To be considered for this study:

• You must be 18 years or age or older
• You must have ulcerative colitis
• You must read, understand, and sign the informed consent form
• Your current medications have been taken regularly and are not expected to change during the course of this study
• Your laboratory results are within an expected range that the study physician and sponsor (Medarex) feel are acceptable
• Women of child bearing potential must be using effective contraception (e.g., oral contraceptives, IUD, double- barrier method of condom and spermicide) for at 1 month prior to study entry and agree to continue contraception for the duration of participation in the study
• Sexually active male patients must use a barrier method of contraception during the course of the study

You will not be eligible for admission into the study if you have:

• A history of colectomy (an operation to remove your colon), partial colectomy, current ostomy (a surgical procedure, in which an artificial opening is made in the abdomen for eliminating stool), or pouchitis (some ulcerative colitis may require a surgical procedure to create an internal pouch from part of the small intestine that will collect the stool, the inflammation of the lining of this pouch is calles pouchitis).
• Toxic megacolon, a serious complication of inflammatory bowel disease such as ulcerative colitis, it occurs when gases collect in the colon causing it to inflate, or other sudden or severe diseases likely to require colectomy
• Contraindication to colonoscopy or sigmoidoscopy
• Prior treatment with any monoclonal antibody or immunoglobulin-based fusion proteins (medication that treat problems with your immune system) = 8 weeks prior to treatment with MDX 1100
• Any experimental treatment = 4 weeks prior to treatment with MDX 1100
• Any history of malignancy/ cancer, excluding adequately treated and cured basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ
• Active major psychiatric disease (patients with stable depression receiving appropriate medical management will be permitted in the study
• Evidence of acute or chronic infection on Screening chest radiography
• Current treatment for tuberculosis infection or positive PPD without prior prophylaxis
• Herpes zoster/ shingles = 3 months prior to screening
• Clinically significant cardiac/heart disease requiring medication, unstable chest pain, heart attack within 6 months, or congestive heart failure
• Active infectious disease requiring i.v. antibiotics within the past 4 weeks or antibiotics at the time of enrollment
• History of cerebrovascular/ stroke disease requiring medication/treatment
• Bleeding disorder
• Seizure disorder requiring active therapy
• Known drug or alcohol abuse
• Pregnant or nursing
• Any underlying medical condition that, in your doctor’s opinion, will make the administration of the study drug hazardous to you or would obscure the interpretation of an adverse event
• Inability or unwillingness to return for follow-up visits
• Positive tests for HIV, Hepatitis B or Hepatitis C indicating active or chronic infections

For more information,

If you would like to learn more about participating in this study, please send an e-mail message using the form below.