Visilizumab for Treatment of Perianal Fistulas in Crohn's Disease

Status Completed

Clinical Trial 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).

Clinical Trial Description

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00267709
Study type	Interventional
Source	Facet Biotech
Contact
Status	Completed
Phase	Phase 2
Start date	February 2005
Completion date	December 2006

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT03815851` - Relationship Between Prophylactic Drainage and Postoperative Complications (PPOI) in Crohn's Patients After Surgery	N/A
Not yet recruiting	`NCT06100289` - A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease	Phase 3
Completed	`NCT02883452` - A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative Colitis	Phase 1
Recruiting	`NCT04777656` - Use of Crohn's Disease Exclusion Diet on Top of Standard Therapy Versus Standard Therapy Alone in Unstable Pediatric Crohn's Disease Patients.	Phase 3
Terminated	`NCT03017014` - A Study to Assess Safety and Effectiveness of Adalimumab for Treating Children and Adolescents With Crohn's Disease in Real Life Conditions
Recruiting	`NCT05428345` - A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
Recruiting	`NCT06053424` - Positron Emission Tomography Study of Changes in [11C]AZ14132516 Uptake Following Administration of AZD7798 to Healthy Participants and Patients With Crohn's Disease	Phase 1
Completed	`NCT02508012` - Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases	N/A
Terminated	`NCT02882841` - MOlecular BIomarkers and Adherent and Invasive Escherichia Coli (AIEC) Detection Study In Crohn's Disease Patients	N/A
Not yet recruiting	`NCT02858557` - The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases	N/A
Completed	`NCT02542917` - Home Versus Postal Testing for Faecal Calprotectin: a Feasibility Study
Completed	`NCT03010787` - A First Time in Human Study in Healthy Volunteers and Patients	Phase 1
Terminated	`NCT02417974` - Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT)	Phase 2
Active, not recruiting	`NCT02316678` - Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics	N/A
Completed	`NCT02193048` - Prospective Evaluation of a Scoring System in Patients Newly Diagnosed With Crohn's Disease
Completed	`NCT02154425` - A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers	Phase 1
Completed	`NCT02197780` - Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD	N/A
Completed	`NCT02265588` - Healthy Approach to Physical and Psychological Problems in Youngsters With IBD (HAPPY-IBD).	N/A
Recruiting	`NCT02395354` - Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease	N/A
Completed	`NCT01951326` - Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease	Phase 3