Status:
COMPLETED
Visilizumab for Moderate to Severe Inflammatory, Nonstricturing, Nonpenetrating Crohn's Disease
Lead Sponsor:
Facet Biotech
Collaborating Sponsors:
PDL BioPharma, Inc.
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
PDL BioPharma, Inc. was formerly known as Protein Design Labs, Inc.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00267722
Start Date
February 1 2005
End Date
December 1 2006
Last Update
March 7 2012
Active Locations (2)
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1
Inflammatory Bowel Disease Center
Los Angeles, California, United States, 90048
2
Mount Sinai School of Medicine
New York, New York, United States, 10029