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Basiliximab in Moderate to Severe Ulcerative Colitis

This study has been completed.
Sponsor:
Information provided by:
Cerimon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00430898
First received: January 31, 2007
Last updated: December 17, 2008
Last verified: December 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Ulcerative Colitis
 Drug: Basiliximab
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Drug Information available for: Basiliximab
U.S. FDA Resources

Further study details as provided by Cerimon Pharmaceuticals:

Primary Outcome Measures:
  • Change in Mayo Score, Safety [ Time Frame: At week 8 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 181
Study Start Date: January 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1. Placebo
Placebo to mimic 40 mg of Simulect
 Drug: Basiliximab
3 doses of 40mg, IV at baseline, week 2, and week 4
Other Name: Simulect
Experimental: 2. 40 mg Simulect
40 mg of Simulect
 Drug: Basiliximab
3 doses of 40mg, IV at baseline, week 2, and week 4
Other Name: Simulect

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00430898

  Show 68 Study Locations
Sponsors and Collaborators
Cerimon Pharmaceuticals
Investigators
Study Director: Daniel Levitt, MD, PhD Cerimon Pharmaceuticals
  More Information

No publications provided by Cerimon Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Cerimon Pharmaceuticals, Inc, Cerimon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00430898     History of Changes
Other Study ID Numbers: BSX-001
Study First Received: January 31, 2007
Last Updated: December 17, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Cerimon Pharmaceuticals:
ulcerative colitis basiliximab

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
 Inflammatory Bowel Diseases
Pathologic Processes
Basiliximab
Antibodies, Monoclonal
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013