Status:
COMPLETED
Visilizumab for Treatment of Perianal Fistulas in 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 Crohn's disease in patients with at least one perianal fistula. The research is being conducte...
Detailed Description
PDL BioPharma, Inc. was formerly known as Protein Design Labs, Inc.
Eligibility Criteria
Inclusion
- 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
- 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
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
NCT00267709
Start Date
February 1 2005
End Date
December 1 2006
Last Update
March 7 2012
Active Locations (1)
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1
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905