NEW RESEARCH STUDY FOR MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

PURPOSE OF THE STUDY:

This clinical research study will assess the safety and efficacy of the investiational 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 and 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

• No prior history of listeria, HIV, any immunodeficiency syndrome, central nervous system demyelinating disease, chronic Hepatitis B infection or untreated tuberculosis

• For other I/E criteria information, please talk with a study coordinator

FOR FURTHER INFORMATION, PLEASE CONTACT:

Study Coordinators:

Amber Bretz, Cheri Casey, Jodi Frazier, Mary Reid, or Dara Stillman

Western States Clinical Research, Inc.
Telephone: 303-940-0909
FAX: 303-940-0308
E-mail: research@wscrinc.com

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Our mission is to promote the health and well-being of humanity by the development of new medicines through high-quality clinical research and a closely held philosophy of striving for excellence.

To find out about the studies that are currently underway at our office, please see Clinical Trials.

Western States Clinical Research Inc. specializes in research studies related to gastroenterology, asthma and allergy, pulmonology, internal medicine, women's health, ophthalmology and dermatology. Our website contains information for physicians, pharmaceutical companies and individuals interested in participating in clinical research.

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