Basiliximab in Moderate to Severe Ulcerative Colitis

Launched by CERIMON PHARMACEUTICALS · Jan 31, 2007

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • In addition to others,
• • Men or women age 18-75
• • Diagnosis of ulcerative colitis confirmed through screening endoscopy.
• • Extent of disease must involve at least the left colon
• • Moderate to severe disease (Mayo Score 6-12). Systemic features of tachycardia, fever, and/or significant anemia should not be present.
• • Inadequate response despite treatment with prednisone 40 - 50 mg/day (or other oral steroid at equivalent dose) orally for a minimum of 14 days immediately preceding study entry
• Exclusion Criteria:
• • In addition to other protocol-defined conditions,
• • Pregnancy
• • Stool study that shows presence of ova and parasites, significant bacterial pathogens, or C. difficile toxin
• • Colitis that is indeterminate, suggestive of Crohn's disease, or isolated to the rectum, based on endoscopic and/or biopsy findings
• • Severely ill patients as evidenced by protocol-defined systemic criteria
• • Chest radiograph abnormalities consistent with an infectious process
• • History of colonic dysplasia
• • HIV infection
• • Known viral Hepatitis B or C infection
• • History of or exposure to tuberculosis within 6 months before study entry