Trial Information

Summary: Ulcerative Colitis Research Study

We are seeking volunteers at least 18 years old with a history of moderate to severe active ulcerative colitis for at least 3 months.

Purpose of The Study:

To determine whether or not the investigational drug has greater clinical efficacy and safety compared to placebo (an inactive substance) as maintenance therapy in subjects with active ulcerative colitis who have not been helped by or could not tolerate medical therapy. A secondary objective is to assess the tolerability and safety of the investigational drug in subjects with ulcerative colitis.

Study Drug Information:

The investigational drug is an agent that is believed to inhibit the activation of T cells. Activated T cells are thought to have a key role in the development of certain disease states, including ulcerative colitis. The study drug will be administered in a one-half hour IV infusion every 2 to 4 weeks. The two initial infusions will last ninety minutes each.

Study Information:

• There are 4 study periods. The screening period lasts from 7 days up to 12 weeks; the induction period lasts 12 weeks, the maintenance period lasts 12 months. In addition, there is an open-label extension period.
• The study medication is an agent that is believed to inhibit the activation of T cells. Activated T cells are thought to play a key role in the development of certain disease states, including ulcerative colitis.
• There is no charge for participation (study procedures and study medication are no-cost).
• Compensation will be provided to participants for study-related time and/or travel.
• Principal Investigator: John Goff, M.D.

Inclusion Criteria

An Inadequate response or intolerance to standard ulcerative colitis treatment is required:

1. In the past, had an inadequate response to one or more of the following treatments:
   1. Oral aminosalicylates (e.g. mesalamine, sulfasalazine, olsalazine, balsalizide) at or above the approved label dose for induction therapy for at least 6 weeks, and/or
   2. Prednisone = 40 mg/day (or equivalent) for at least 2 weeks, and/or
   3. Immunosuppressants [azathioprine = 2 mg/kg/day or 6-mercaptopurine = 1.0 mg/kg/day, (or documentation of a therapeutic concentration of 6-thioguanine nucleotide)] for at least 12 weeks, and/or
   4. An approved anti-TNF agent at an approved labeled dose for at least 8 weeks and/or
   5. Intravenous hydrocortisone = 400 mg/day (or equivalent) for at least 1 week.
2. had been intolerant to one or more of the above mentioned treatments [e.g, unable to achieve doses or treatment durations because of dose limiting side effects (e.g. leukopenia, psychosis, uncontrolled diabetes, elevated liver enzymes)] AND/OR
3. Currently receiving one or more of the following treatments:
   1. Oral aminosalicylates (e.g. mesalamine, sulfasalazine, olsalazine, balsalizide) at or above the approved label dose for at least 6 weeks and/or
   2. Prednisone = 20 mg/day (or equivalent) for at least 4 weeks and/or
   3. Immunosuppressants [azathioprine = 2 mg/kg/day or 6-mercaptopurine = 1.0 mg/kg/day, (or documentation of a therapeutic concentration of 6-thioguanine nucleotide)] for at least 12 weeks.

Exclusion Criteria

• Females of childbearing potential must be willing to use an adequate method of birth control throughout the study and for up to 10 weeks afterward.
• Current colostomy or ileostomy are not allowed.
• Current total parenteral nutrition is not allowed.
• No cancer within the past 5 years, except for a simple skin cancer that has been cured by local resection.
• No serious bacterial infection in the past 3 months, and no chronic bacterial infection.  An acute bacterial infection is OK if it has been treated with antibiotics and has resolved.

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