Back to resultsA Clinical Trial of Natalizumab in Individuals With Moderately to Severely Active Crohn's Disease
Primary Purpose
Crohn's Disease
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
natalizumab
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's disease, Inflammatory Bowel Disease, IBD, Gastroenterology, Regional Enteritis, Colitis
Eligibility Criteria
Males and females 18 years of age or older Diagnosis of Crohn's disease for at least 6 months Females must not be pregnant or breastfeeding Must not have previously taken natalizumab Use of some other Crohn's disease medications is permitted, but will be closely supervised
Sites / Locations
- Harmony Clinical Research
- Advanced Clinical Therapeutics
- Advanced Clinical Research Institute
- Cedars-Sinai Medical Center
- Digestive Diseases Foundation
- David Geffen School of Medicine at UCLA, Division of Digestive Diseases
- Community Clinical Trials
- UCSF / Mt. Zion IBD Center
- Shared Medical Research Foundation
- Lynn Institute of the Rockies
- Rocky Mountain Gastroenterology
- Arapahoe Gastroenterology
- Center for Medical Research, LLC
- Morowitz, Marion, Laessing, Shocket, Bashir, Steinberg, Salcedo
- Malcolm Randall VA Medical Center
- Borland Groover Clinic
- Miami Research Associates, Inc.
- Waterside Clinical Research Services, Inc.
- Shafran Gastroenterology Center
- Atlanta Gastroenterology Associates
- University of Chicago Hospitals
- Outpatient Clinical Research Facility
- Indianapolis Gastroenterology Research Foundation
- University of Kentucky Medical Center
- University of Louisville
- Drug Research Service, Inc.
- Metropolitan Gastroenterology Group, PC / Chevy Chase Clinical Research
- Minnesota Gastroenterology, P.A.
- Mayo Clinic
- Long Island Clinical Research Associates, LLP
- New York Center for Clinical Research
- Mount Sinai School of Medicine
- Rochester Institute for Digestive Diseases and Sciences, Inc.
- Asheville Gastroenterology Associates
- University of North Carolina
- Charlotte Gastroenterology & Hepatology, PLLC.
- Wake Research Associates
- Wake Forest University School of Medicine
- Consultants for Clinical Research, Inc.
- Cleveland Clinic Foundation
- Oklahoma Foundation for Digestive Research
- Lynn Health Science Institute
- Oklahoma Gastroenterology Associates
- Milton S. Hershey Medical Center
- Allegheny Center for Digestive Health
- Gastroenterology Associates
- Medical University of South Carolina - Digestive Disease Center
- Southeastern Clinical Research
- Gastroenterology Center of the Midsouth, P.C.
- Summit Research Solutions
- Nashville Medical Research Institute
- Austin Gastroenterology, PA
- Atilla Ertan, MD, PA
- Gastroenterology Clinic of San Antonio, P.A.
- Wasatch Clinical Research
- UVA Health System
- Gastroenterology Associates of Tidewater
- Internal Medicine Associates
- McGuire DVAMC GI (111N)
- Virginia Mason Medical Center
- Tacoma Digestive Disease Research Center
- Aurora Helath Care
- Medical College of Wisconsin
- University of Calgary
- GI Research
- University of Alberta
- Liver and Intestinal Research Centre
- St. Paul's Hospital
- Health Sciences Center
- Queen Elizabeth II Science Center
- McMaster University Medical Centre
- Sunnybrook & Women's College Health Sciences Center
- Mount Sinai Hospital
- Montreal General Hospital
- Chauq Hopital Du St. Sacrement
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00078611
First Posted
March 1, 2004
Last Updated
June 14, 2016
Sponsor
Biogen
Collaborators
Elan Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00078611
Brief Title
A Clinical Trial of Natalizumab in Individuals With Moderately to Severely Active Crohn's Disease
Official Title
A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Intravenous Antegren(TM) (Natalizumab) in Subjects With Moderately to Severely Active Crohn's Disease With Elevated C-Reactive Protein
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
March 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen
Collaborators
Elan Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
The purpose of this trial is to evaluate natalizumab in individuals with moderately to severely active Crohn's Disease.
Detailed Description
Natalizumab is a humanized monoclonal antibody currently being investigated as a potential treatment for Crohn's disease. It is believed to work by preventing white blood cells from moving from the blood stream into the bowel tissue. These cells are thought to cause damage to the bowel, leading to the symptoms of Crohn's disease. Elan Pharmaceuticals is currently sponsoring an international study evaluating the safety and efficacy of natalizumab in individuals with moderately to severely active Crohn's disease. Individuals with Crohn's disease will be randomly assigned to receive either placebo (an inactive solution) or natalizumab by intravenous infusion (this means putting it directly into a vein in the arm). There will be a one out of two chance of receiving natalizumab and a one out of two chance of receiving placebo. Participants in the study will receive several infusions of natalizumab or placebo at 4-week intervals. Eligible participants will then have the opportunity to enroll into an extension study that will allow all participants to receive natalizumab. For those patients who do not enroll into the extension study, the total participation in this study will last for approximately 22 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's disease, Inflammatory Bowel Disease, IBD, Gastroenterology, Regional Enteritis, Colitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
462 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
natalizumab
Other Intervention Name(s)
Antegren
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Males and females 18 years of age or older
Diagnosis of Crohn's disease for at least 6 months
Females must not be pregnant or breastfeeding
Must not have previously taken natalizumab
Use of some other Crohn's disease medications is permitted, but will be closely supervised
Facility Information:
Facility Name
Harmony Clinical Research
City
Oro Valley
State/Province
Arizona
ZIP/Postal Code
85739
Country
United States
Facility Name
Advanced Clinical Therapeutics
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Advanced Clinical Research Institute
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Digestive Diseases Foundation
City
Los Angeles
State/Province
California
ZIP/Postal Code
90067
Country
United States
Facility Name
David Geffen School of Medicine at UCLA, Division of Digestive Diseases
City
Los Angeles
State/Province
California
ZIP/Postal Code
90092-7019
Country
United States
Facility Name
Community Clinical Trials
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
UCSF / Mt. Zion IBD Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Shared Medical Research Foundation
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Facility Name
Lynn Institute of the Rockies
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Rocky Mountain Gastroenterology
City
Golden
State/Province
Colorado
ZIP/Postal Code
80215
Country
United States
Facility Name
Arapahoe Gastroenterology
City
LIttleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Center for Medical Research, LLC
City
Manchester
State/Province
Connecticut
ZIP/Postal Code
06040
Country
United States
Facility Name
Morowitz, Marion, Laessing, Shocket, Bashir, Steinberg, Salcedo
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Malcolm Randall VA Medical Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Borland Groover Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Miami Research Associates, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Waterside Clinical Research Services, Inc.
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Shafran Gastroenterology Center
City
Winterpark
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Atlanta Gastroenterology Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
University of Chicago Hospitals
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Outpatient Clinical Research Facility
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5250
Country
United States
Facility Name
Indianapolis Gastroenterology Research Foundation
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46227
Country
United States
Facility Name
University of Kentucky Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Drug Research Service, Inc.
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70001
Country
United States
Facility Name
Metropolitan Gastroenterology Group, PC / Chevy Chase Clinical Research
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Minnesota Gastroenterology, P.A.
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55446
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Long Island Clinical Research Associates, LLP
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
New York Center for Clinical Research
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10028
Country
United States
Facility Name
Rochester Institute for Digestive Diseases and Sciences, Inc.
City
Rochester
State/Province
New York
ZIP/Postal Code
14607
Country
United States
Facility Name
Asheville Gastroenterology Associates
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Charlotte Gastroenterology & Hepatology, PLLC.
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Wake Forest University School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27012
Country
United States
Facility Name
Consultants for Clinical Research, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oklahoma Foundation for Digestive Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Oklahoma Gastroenterology Associates
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Allegheny Center for Digestive Health
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Gastroenterology Associates
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02904
Country
United States
Facility Name
Medical University of South Carolina - Digestive Disease Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Southeastern Clinical Research
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Gastroenterology Center of the Midsouth, P.C.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Summit Research Solutions
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Nashville Medical Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Austin Gastroenterology, PA
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Atilla Ertan, MD, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Gastroenterology Clinic of San Antonio, P.A.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Wasatch Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
UVA Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Gastroenterology Associates of Tidewater
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
Internal Medicine Associates
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
Facility Name
McGuire DVAMC GI (111N)
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Tacoma Digestive Disease Research Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Aurora Helath Care
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Facility Name
GI Research
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 4B9
Country
Canada
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2C8
Country
Canada
Facility Name
Liver and Intestinal Research Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1H2
Country
Canada
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
Health Sciences Center
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
Queen Elizabeth II Science Center
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
McMaster University Medical Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Sunnybrook & Women's College Health Sciences Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Montreal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Chauq Hopital Du St. Sacrement
City
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Clinical Trial of Natalizumab in Individuals With Moderately to Severely Active Crohn's Disease
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