Visilizumab for Moderate to Severe Inflammatory, Nonstricturing, Nonpenetrating Crohn's Disease

This study has been completed.
Sponsor:
Collaborator:
PDL BioPharma, Inc.
Information provided by (Responsible Party):
Facet Biotech
ClinicalTrials.gov Identifier:
NCT00267722
First received: December 19, 2005
Last updated: March 6, 2012
Last verified: March 2012
  Purpose

The purpose of the study is to evaluate an intravenous (by injection) investigational medication to treat moderate to severe inflammatory, nonstricturing, nonpenetrating Crohn's disease. The research is being conducted at up to 5 clinical research sites in the US and Europe and is open to both men and women ages 18 to 70 years old. Participants in the study will have a number of visits to a research site up to 17 months. All study-related care and medication is provided to qualified participants at no cost: this includes all visits, examinations and laboratory work.

Visilizumab is a humanized antibody (antibodies are proteins that are normally made by the immune system to help defend the body from infections and other foreign substances) that is directed against T cells. Visilizumab selectively attacks problematic T cells and, in doing so, it may prevent them from causing inflammation. Visilizumab has also been observed to have a suppressive effect on the body's immune system (system in the body that reacts to foreign or occasionally one's own proteins).


Condition Intervention Phase
Crohn's Disease
Drug: Visilizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2a, Open-label Study of Visilizumab in Patients With Moderate-to-Severe Inflammatory, Nonstricturing, Nonpenetrating Forms of Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Facet Biotech:

Primary Outcome Measures:
  • Clinical response, defined as a 100-point or more decrease in Crohn's Disease Activity Index, without an accompanying increase in dose of concomitant medications, additional medications, or Crohn's Disease-related surgery.

Secondary Outcome Measures:
  • Frequency of clinical remission, duration of effect, endoscopic evidence of mucosal healing, change in C-reactive protein levels, pharmacokinetics, and immunogenicity.

Estimated Enrollment: 18
Study Start Date: February 2005
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Detailed Description:

PDL BioPharma, Inc. was formerly known as Protein Design Labs, Inc.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-70 years old
  • Diagnosis of moderate-to-severe inflammatory, nonstricturing, nonpenetrating Crohn's disease, defined as Crohn's Disease Activity Index greater than or equal to 250, C-reactive protein greater than or equal to upper limit of normal, and endoscopic evidence of moderate-to-severe active inflammatory disease
  • Test negative for Clostridium difficile within 3 weeks
  • Signed informed consent, including permission to use protected health information

Exclusion Criteria:

  • History of lymphoproliferative disorder or prior malignancy within 5 years or current malignancy
  • Pregnant or nursing
  • HIV, Hepatitis B or Hepatitis C infection
  • Presence of obstructive symptoms, confirmed by endoscopy
  • Serious infections within 12 months
  • Active infections that require antibiotic therapy
  • Started or changed dose of sulfasalazine, 5-aminosalicylic acid; or antibiotics, probiotics, or topical therapies for Crohn's within 2 weeks
  • Serious infections that required IV antibiotic therapy or hospitalization within 8 weeks
  • Increase dose of corticosteroid medication within 2 weeks
  • Received a live vaccine within 6 weeks
  • Received any monoclonal antibodies or investigational agents within 3 months
  • Received cyclosporine or tacrolimus (FK506) within 4 weeks
  • Dose change or discontinuation from 6-mercaptopurine, azathioprine, or methotrexate within 4 weeks
  • Significant organ dysfunction
  • Likely to require surgery in the next 6 months
  • History of lymphoproliferative disorder
  • History of tuberculosis or mycobacteria infection or positive chest x-ray
  • History of thrombophlebitis or pulmonary embolus
  • History of immune deficiency or autoimmune disorders other than Crohn's
  • History of subtherapeutic blood levels of anticonvulsive medications within 1 week
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00267722

Locations
United States, California
Inflammatory Bowel Disease Center
Los Angeles, California, United States, 90048
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Sponsors and Collaborators
Facet Biotech
PDL BioPharma, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Facet Biotech
ClinicalTrials.gov Identifier: NCT00267722     History of Changes
Other Study ID Numbers: 291-412
Study First Received: December 19, 2005
Last Updated: March 6, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Crohn Disease
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on October 28, 2014