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Trial record 5 of 13 for:    visilizumab

Visilizumab for Treatment of Perianal Fistulas in Crohn's Disease

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. Identifier: NCT00267709
Recruitment Status : Completed
First Posted : December 21, 2005
Last Update Posted : March 7, 2012
PDL BioPharma, Inc.
Information provided by (Responsible Party):
Facet Biotech

Brief Summary:

The purpose of the study is to evaluate an intravenous (by injection) investigational medication to treat Crohn's disease in patients with at least one perianal fistula. 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 over a 17 month period. 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 or disease Intervention/treatment Phase
Crohn's Disease Drug: Visilizumab Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2a, Open-label Study of Visilizumab for Treatment of Perianal Fistulas in Patients With Crohn's Disease
Study Start Date : February 2005
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Clinical response, defined as external closure of at least 50% of perianal fistulas, without an accompanying increase in dose of concomitant medications, the addition of new medications, or Crohn's Disease-related surgery.

Secondary Outcome Measures :
  1. Frequency of complete clinical response, confirm internal healing by MRI, duration of disease improvement.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18-70 years old
  • Diagnosis of Crohn's disease with fistula
  • 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, within 6 months
  • Likely to require surgery in the next 6 months
  • Serious or active infections within 1 year
  • Active infections that require antibiotic therapy
  • Serious infections that require IV antibiotics or hospitalization within 8 weeks
  • Started or changed dose of sulfasalazine, 5-aminosalicylic acid (5-ASA), antibiotics, probiotics, or topical therapies for Crohn's within 2 weeks
  • Had increased dose of corticosteroids 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 of 6-mercaptopurine, azathioprine, or methotrexate within 4 weeks
  • Significant organ dysfunction
  • History of lymphoproliferative disorder
  • History of tuberculosis, mycobacterial infection, or positive chest x-ray
  • History of thrombophlebitis or pulmonary embolus
  • History of immune deficiency or autoimmune disorders (other than Crohn's disease)
  • History of seizure with subtherapeutic levels of anticonvulsive medication within one week

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 identifier (NCT number): NCT00267709

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United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Facet Biotech
PDL BioPharma, Inc.

Additional Information:
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Responsible Party: Facet Biotech Identifier: NCT00267709    
Other Study ID Numbers: 291-411
First Posted: December 21, 2005    Key Record Dates
Last Update Posted: March 7, 2012
Last Verified: March 2012
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
Immunologic Factors
Physiological Effects of Drugs