Summary:
Open Label Study for Moderately to Severely Active Crohn’s Disease
We are looking for people aged 18 to 75 years old who have been diagnosed (via radiologic or endoscopic evaluation) for at least 16 weeks with moderate to severe Crohn’s Disease.

Purpose of the study:
The purpose of this study is to make the study drug available, by means of open label treatment to patients suffering from moderately to severely active Crohn’s Disease, who have failed to respond to, lost response to, or are intolerant of infliximab (Remicade ®). Open label treatment means that all participants will receive the investigational medication.

Study information:

• Duration of the study is approximately 9 months, or until the study drug becomes commercially available for the treatment of Crohn’s Disease.
• Study participants will be seen at Screening, Baseline, Weeks 4, 8, 12, and then approximately every 12 weeks until the study terminates, for a total of 8 visits.
• Study procedures include physical exams, a skin test (for tuberculosis), a CXR (for those with a positive skin test), and labwork.
• 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 $25 per visit; total possible = $200. Please note that there is no stipend for the pre-study visit.
• Investigator: John Goff, M.D. of Rocky Mountain Gastroenterology Associates

Inclusion/Exclusion:

• Male or female, ages 18 to 75 years old
• Diagnosis of moderate to severe Crohn’s Disease occurring at least during the prior 16 weeks (Severity will be determined by the study physician)
• Crohn’s Disease diagnosis must have been made previously by radiologic or endoscopic evaluation
• Must have failed prior infliximab (Remicade?) therapy, with a minimum of 8 weeks since treatment
• General good health besides Crohn’s Disease; 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, please talk with a study coordinator

Contact:
Amber Bretz, Cheri Casey, Jodi Frazier or Dara Stillman
Western States Clinical Research, Inc.
9201 W. 44th Avenue
Wheat Ridge, CO 80033
Telephone: 303-940-9773
Fax: 303-940-0308
Email: research@wscrinc.com

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INVESTIGATIONAL NEW APPROACH FOR CROHN’S DISEASE

We are looking for people aged 18 to 75 years old diagnosed for at least 3 months with moderate to severe Crohn's Disease.
The purpose of the study is to provide data to show whether the Adacolumn Apheresis System can successfully treat Crohn's Disease.  Elevated levels of white blood cells in the mucosal tissue of the bowel are associated with inflammatory bowel disease, such as Crohn's Disease.  Previous clinical studies have suggested that the selective removal of there white blood cells through an apheresis procedure may be a viable treatment for Crohn's Disease.
 
STUDY INFORMATION:

• Duration of the study is approximately 24-26 weeks. Study participants may continue on most current therapies during the study. Must be able to undergo 10 one-hour procedures within a 10 week period. There is a one in three chance of receiving the sham, or placebo, treatment procedure. There is no charge for participation. Compensation ($970 total possible) is provided to participants for study-related time and/or travel, based on visits completed.  Note there is no compensation provided for a pre-screen visit.
• Investigator:  John Goff, M.D. of Rocky Mountain Gastroenterology Associates

Contact:
Amber Bretz, CCRC or Cheri Casey, CCRC
Western States Clinical Research, Inc.
Phone:303-940-9773
Fax: 303-940-0308
E-mail: research@wscrinc.com