Crohn's Disease Clinical Trial
Official title:
A Phase 2a, Open-label Study of Visilizumab for Treatment of Perianal Fistulas in Patients With Crohn's Disease
Verified date | March 2012 |
Source | Facet Biotech |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 18 |
Est. completion date | December 2006 |
Est. primary completion date | December 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Facet Biotech | PDL BioPharma, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Frequency of complete clinical response, confirm internal healing by MRI, duration of disease improvement. |
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 |
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 | |
Recruiting |
NCT05428345 -
A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
|
||
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 |
NCT03010787 -
A First Time in Human Study in Healthy Volunteers and Patients
|
Phase 1 | |
Completed |
NCT02542917 -
Home Versus Postal Testing for Faecal Calprotectin: a Feasibility Study
|
||
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 |
NCT02265588 -
Healthy Approach to Physical and Psychological Problems in Youngsters With IBD (HAPPY-IBD).
|
N/A | |
Completed |
NCT02197780 -
Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD
|
N/A | |
Completed |
NCT02154425 -
A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers
|
Phase 1 | |
Completed |
NCT02193048 -
Prospective Evaluation of a Scoring System in Patients Newly Diagnosed With Crohn's Disease
|
||
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 |