Trial Information

Summary: Active Crohn's Disease: International, Multicenter, Double-Blind, Placebo-controlled study for moderate to severe Crohn's Disease.

Study Description

Screening period of 7-10 days

  • Physical examination, laboratory tests & Chest X-ray
  • Daily diary
  • Questionnaire

Treatment period of 10 weeks

  • Monthly infusions
  • 5 Study visits (3 infusions & 3 office visits)

Follow-up phase

  • 12, 20 & 32 week visits
  • Potential candidate for long term study
Inclusion
  • 18 years of age or older
  • History of Crohn's Disease for at least 6 months confirmed radiological or endoscopic confirmation
  • Stable low dose prednisolone (or equivalent)
Exclusion Criteria
  • Oral prednisolone (or equivalent) exceeding 25 mg/day
  • Use of anti-TNF therapy in the last 90 days
  • Use of herbal preparations during therapy
  • Subject with colostomy, ileostomy or short bowel syndrome

Contact:

Gail Danhour, RN
Rocky Mountain Clinical Research, Inc.
29 Rogers Court
Golden, CO 80401
Telephone: 303-279-1550
Fax: 303-278-2602
Email:

Profile Page: Rocky Mountain Clinical Research, Inc., Golden, CO

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Trial listings updated: June 1, 2008 at 5:43:22 AM


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