Trial Information

Summary: New Research Study for Moderately to Severely Active Ulcerative Colitis

New Research Study for Moderately to Severely Active Ulcerative Colitis

A multi-center, Randomized, Double-blind, Placebo-controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderately to Severely Active Ulcerative Colitis

We are looking for people at least 18 years old who have been diagnosed for 90 days or more with moderate to severe ulcerative colitis. An investigational drug administered by subcutaneous injection is being evaluated for ulcerative colitis.

Purpose of the study:

This clinical research study will assess the safety and efficacy of the investigational study medication for the induction and maintenance of clinical remission in study subjects who have moderately to severely active ulcerative colitis.

Investigational study drug:

The investigational study drug is a human anti-TNF monoclonal antibody, a molecule consisting of a large number of amino acids that inhibits the action of TNF. TNF is a naturally occurring chemical in the human body that promotes inflammation. TNF molecules are found in increased concentrations in the blood, colonic tissue and stools of patients with ulcerative colitis.

Study information:

• Duration of the study is up to 55 weeks.
• Investigational study drug or placebo will be administered by subcutaneous injection every 2 weeks following randomization at the Baseline visit. Random treatment assignment will occur in a double-blinded method at a ratio of 1:1. Chance of receiving placebo is 50%.
• Study participants will be seen at Screening (the screening period lasts up to 3 weeks), at Baseline (randomization), and at Weeks 2, 4, 8, 12, 16, 20, 26, 32, 38, 44 and 52, for a total of 13 study visits. There may also be a pre-study visit.
• Study procedures include physical exams, a flexible sigmoidoscopy or colonoscopy at screening, a flexible sigmoidoscopy at Week 8, Week 32 & Week 52, a CXR, an ECG, and labwork.
• Upon completion of the study, participants will have the option to enroll into an extension study where they will receive open-label adalimumab.
• There is no charge for participation.
• A stipend will be provided to study participants for study related time and/or travel in the amount of $75 each for the Screen Visit and for the Week 8, 32 & 52 Visits; $35 each for the Baseline Visit and for the Week 2, 4, 12, 16, 20, 26, 38, and 44 Visits. Total possible = $615. Please note that there is no stipend for the pre-study visit.
• Investigator: John Goff, M.D. of Rocky Mountain Gastroenterology Associates

Inclusion/Exclusion Criteria (Partial List):

• Male or female, at least 18 years old
• Diagnosis of ulcerative colitis for at least the past 90 days
• Must have tried other treatments specified by the study protocol
• Must be in general good health besides ulcerative colitis; other medical conditions must be well-controlled

Patient Exclusion Criteria

• No prior history of listeria, HIV, any immunodeficiency syndrome, central nervous system demyelinating disease, chronic Hepatitis B infection or untreated tuberculosis
• For other inclusion/exclusion criteria information, please talk with a study coordinator

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