NCT00267722

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 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 up to 17 months. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2005

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2005

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

March 7, 2012

Status Verified

March 1, 2012

Enrollment Period

1.8 years

First QC Date

December 19, 2005

Last Update Submit

March 6, 2012

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

  • Clinical response, defined as a 100-point or more decrease in Crohn's Disease Activity Index, without an accompanying increase in dose of concomitant medications, additional medications, or Crohn's Disease-related surgery.

Secondary Outcomes (1)

  • Frequency of clinical remission, duration of effect, endoscopic evidence of mucosal healing, change in C-reactive protein levels, pharmacokinetics, and immunogenicity.

Interventions

VisilizumabDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

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
  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Inflammatory Bowel Disease Center

Los Angeles, California, 90048, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

visilizumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal 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(2)