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Basiliximab Maintenance in Ulcerative Colitis

This study has been terminated.
(lack of efficacy)
Sponsor:
Information provided by:
Cerimon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01061996
First received: February 2, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted

February 2, 2010
February 2, 2010
July 2007
December 2008   (final data collection date for primary outcome measure)
Assess the safety of basiliximab in subjects with ulcerative colitis [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Evaluate the efficacy and assess the immunogenicity of t his multiple-dose maintenance regimen in this population [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Basiliximab Maintenance in Ulcerative Colitis
An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis

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

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ulcerative Colitis
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
Experimental: 1
Intervention: Drug: Basiliximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
88
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01061996
BSX-002
No
Shaily J. Reichert, Cerimon Pharmaceuticals, Inc.
Cerimon Pharmaceuticals
Not Provided
Study Director: Shaily J. Reichert Cerimon Pharmaceuticals
Cerimon Pharmaceuticals
February 2010

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