Trial | NCT00430898  Report issue

Title

Basiliximab in Moderate to Severe Ulcerative Colitis
A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, With Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    181
The purpose of this study is to assess the safety, effectiveness and pharmacokinetics of two levels of intravenous basiliximab in ulcerative colitis, compared to placebo.
Study Started
Jan 31
2007
Primary Completion
Sep 30
2008
Study Completion
Sep 30
2008
Last Update
Dec 18
2008
Estimate

Drug Basiliximab

3 doses of 40mg, IV at baseline, week 2, and week 4

  • Other names: Simulect

1. Placebo Placebo Comparator

Placebo to mimic 40 mg of Simulect

2. 40 mg Simulect Experimental

40 mg of Simulect

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
No Results Posted