Visilizumab for Treatment of Perianal Fistulas in Crohn's Disease

NCT00267709 | Completed Phase 2

• 1 other identifier: 291-411
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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).

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (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 Outcomes (1)

• Frequency of complete clinical response, confirm internal healing by MRI, duration of disease improvement.

Interventions

Visilizumab DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Facet Biotech: lead
• PDL BioPharma, Inc.: collaborator

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

visilizumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2005
• First Posted: December 21, 2005
• Study Start: February 1, 2005
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: March 7, 2012

Record last verified: 2012-03

Locations

US (1)