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Basiliximab Maintenance in 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: NCT01061996
Recruitment Status : Terminated (lack of efficacy)
First Posted : February 4, 2010
Last Update Posted : February 4, 2010
Information provided by:
Cerimon Pharmaceuticals

Brief Summary:

Primary Objective Safety: assess the safety of basiliximab 40 mg, given every 4 weeks, in subjects with ulcerative colitis who completed previous basiliximab studies.

Secondary Objectives: evaluate the efficacy and assess the immunogenicity of this multiple-dose maintenance regimen in this population

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Basiliximab Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis
Study Start Date : July 2007
Primary Completion Date : December 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: 1 Drug: Basiliximab
Study Drug: basiliximab 40 mg, given as a short intravenous infusion Dosing Schedule: once every 4 weeks Concomitant Therapy: Oral corticosteroids (prednisone or equivalent) will be tapered during the first few months of the study participation Duration of Study Participation: The duration of individual study participation will vary.
Other Name: Simulect

Primary Outcome Measures :
  1. Assess the safety of basiliximab in subjects with ulcerative colitis [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Evaluate the efficacy and assess the immunogenicity of t his multiple-dose maintenance regimen in this population [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Previously met eligibility criteria in the previous basiliximab UC study
  2. Must have a total Mayo score at entry consistent with clinical response or clinical remission.
  3. Signed a current IRB/IEC-approved informed consent form
  4. Females of childbearing potential must use an effective birth control method, and be willing to continue birth control during the study, and for 4 months after the last dose of study drug.
  5. Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months before study entry, hysterectomy, or bilateral oophorectomy at least 2 months before study entry) or post-menopausal for at least 2 years.

Exclusion Criteria:

  1. Subject is severely ill, as evidenced by more than 6 episodes of loose stools, all of them bloody, during a 24-hour period within the prior 7 days, concurrent with any of the following systemic features:

    • Heart rate > 90 beats/min at rest
    • Temperature > 37.8 degrees C
    • Hemoglobin < 10.5 g/dL
  2. Subject is currently receiving a restricted/prohibited concomitant medication
  3. Subject has undergone colectomy (total, or subtotal)
  4. Subject is pregnant or breast-feeding
  5. Prior noncompliance with previous study visit schedule and requirements

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01061996

United Kingdom
Bristol, United Kingdom
Sponsors and Collaborators
Cerimon Pharmaceuticals
Study Director: Shaily J. Reichert Cerimon Pharmaceuticals

Responsible Party: Shaily J. Reichert, Cerimon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01061996     History of Changes
Other Study ID Numbers: BSX-002
First Posted: February 4, 2010    Key Record Dates
Last Update Posted: February 4, 2010
Last Verified: February 2010

Keywords provided by Cerimon Pharmaceuticals:
Ulcerative Colitis

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