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Basiliximab in Moderate to Severe Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00430898
Recruitment Status : Completed
First Posted : February 2, 2007
Last Update Posted : December 18, 2008
Sponsor:
Information provided by:
Cerimon Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE January 31, 2007
First Posted Date  ICMJE February 2, 2007
Last Update Posted Date December 18, 2008
Study Start Date  ICMJE January 2007
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2008)
Change in Mayo Score, Safety [ Time Frame: At week 8 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 31, 2007)
Change in Mayo Score, Safety
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2008)
Clinical remission at week 4; clinical response at weeks 4 and 8; use of rescue medication; hospitalization or colectomy; and concomitant steroid use [ Time Frame: at week 4 and 8 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2007)
Pharmacokinetics
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Basiliximab in Moderate to Severe Ulcerative Colitis
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis
Intervention  ICMJE Drug: Basiliximab
3 doses of 40mg, IV at baseline, week 2, and week 4
Other Name: Simulect
Study Arms  ICMJE
  • Placebo Comparator: 1. Placebo
    Placebo to mimic 40 mg of Simulect
    Intervention: Drug: Basiliximab
  • Experimental: 2. 40 mg Simulect
    40 mg of Simulect
    Intervention: Drug: Basiliximab
Publications * Sands BE, Sandborn WJ, Creed TJ, Dayan CM, Dhanda AD, Van Assche GA, Greguš M, Sood A, Choudhuri G, Stempien MJ, Levitt D, Probert CS. Basiliximab does not increase efficacy of corticosteroids in patients with steroid-refractory ulcerative colitis. Gastroenterology. 2012 Aug;143(2):356-64.e1. doi: 10.1053/j.gastro.2012.04.043. Epub 2012 Apr 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: May 13, 2008)
181
Original Enrollment  ICMJE
 (submitted: January 31, 2007)
135
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Czech Republic,   India,   Poland,   Russian Federation,   Slovakia,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00430898
Other Study ID Numbers  ICMJE BSX-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cerimon Pharmaceuticals, Inc, Cerimon Pharmaceuticals, Inc.
Study Sponsor  ICMJE Cerimon Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Daniel Levitt, MD, PhD Cerimon Pharmaceuticals
PRS Account Cerimon Pharmaceuticals
Verification Date December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP