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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
  Purpose

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 Intervention Phase
Ulcerative Colitis
 Drug: Basiliximab
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in 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:
  • Assess the safety of basiliximab in subjects with ulcerative colitis [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 88
Study Start Date: July 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01061996

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

No publications provided

Responsible Party: Shaily J. Reichert, Cerimon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01061996     History of Changes
Other Study ID Numbers: BSX-002
Study First Received: February 2, 2010
Last Updated: February 2, 2010
Health Authority: Belgium: Directorate general for the protection of Public health: Medicines
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Czech Republic: State Institute for Drug Control
India: Drugs Controller General of India
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Cerimon Pharmaceuticals:
Ulcerative Colitis

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 21, 2013