ClinicalTrials.gov record
Completed Phase 3 Interventional

A Clinical Trial of Natalizumab in Individuals With Moderately to Severely Active Crohn's Disease

ClinicalTrials.gov ID: NCT00078611

Public ClinicalTrials.gov record NCT00078611. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 20, 2026, 10:02 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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 identification

NCT ID
NCT00078611
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Biogen
Industry
Enrollment
462 participants

Conditions and interventions

Interventions

  • natalizumab Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 29, 2004
Primary completion
Feb 28, 2005
Completion
Feb 28, 2005
Last update posted
Jun 15, 2016

2004 – 2005

United States locations

U.S. sites
63
U.S. states
26
U.S. cities
57
Facility City State ZIP Site status
Harmony Clinical Research Oro Valley Arizona 85739
Advanced Clinical Therapeutics Tucson Arizona 85712
Advanced Clinical Research Institute Anaheim California 92801
Cedars-Sinai Medical Center Los Angeles California 90048
Digestive Diseases Foundation Los Angeles California 90067
David Geffen School of Medicine at UCLA, Division of Digestive Diseases Los Angeles California 90092-7019
Community Clinical Trials Orange California 92868
UCSF / Mt. Zion IBD Center San Francisco California 94115
Shared Medical Research Foundation Tarzana California 91356
Lynn Institute of the Rockies Colorado Springs Colorado 80909
Rocky Mountain Gastroenterology Golden Colorado 80215
Arapahoe Gastroenterology Littleton Colorado 80120
Center for Medical Research, LLC Manchester Connecticut 06040
Morowitz, Marion, Laessing, Shocket, Bashir, Steinberg, Salcedo Washington D.C. District of Columbia 20010
Malcolm Randall VA Medical Center Gainesville Florida 32608
Borland Groover Clinic Jacksonville Florida 32256
Miami Research Associates, Inc. Miami Florida 33173
Waterside Clinical Research Services, Inc. West Palm Beach Florida 33407
Shafran Gastroenterology Center Winterpark Florida 32789
Atlanta Gastroenterology Associates Atlanta Georgia 30342
University of Chicago Hospitals Chicago Illinois 60637
Outpatient Clinical Research Facility Indianapolis Indiana 46202-5250
Indianapolis Gastroenterology Research Foundation Indianapolis Indiana 46227
University of Kentucky Medical Center Lexington Kentucky 40536
University of Louisville Louisville Kentucky 40202
Drug Research Service, Inc. Metairie Louisiana 70001
Metropolitan Gastroenterology Group, PC / Chevy Chase Clinical Research Chevy Chase Maryland 20815
Minnesota Gastroenterology, P.A. Plymouth Minnesota 55446
Mayo Clinic Rochester Minnesota 55905
Long Island Clinical Research Associates, LLP Great Neck New York 11021
New York Center for Clinical Research Lake Success New York 11042
Mount Sinai School of Medicine New York New York 10028
Rochester Institute for Digestive Diseases and Sciences, Inc. Rochester New York 14607
Asheville Gastroenterology Associates Asheville North Carolina 28801
University of North Carolina Chapel Hill North Carolina 27599
Charlotte Gastroenterology & Hepatology, PLLC. Charlotte North Carolina 28207
Wake Research Associates Raleigh North Carolina 27612
Wake Forest University School of Medicine Winston-Salem North Carolina 27012
Consultants for Clinical Research, Inc. Cincinnati Ohio 45219
Cleveland Clinic Foundation Cleveland Ohio 44195
Oklahoma Foundation for Digestive Research Oklahoma City Oklahoma 73104
Lynn Health Science Institute Oklahoma City Oklahoma 73112
Oklahoma Gastroenterology Associates Tulsa Oklahoma 74104
Milton S. Hershey Medical Center Hershey Pennsylvania 17033
Allegheny Center for Digestive Health Pittsburgh Pennsylvania 15212
Gastroenterology Associates Providence Rhode Island 02904
Medical University of South Carolina - Digestive Disease Center Charleston South Carolina 29425
Southeastern Clinical Research Chattanooga Tennessee 37403
Gastroenterology Center of the Midsouth, P.C. Memphis Tennessee 38120
Summit Research Solutions Memphis Tennessee 38120
Nashville Medical Research Institute Nashville Tennessee 37205
Austin Gastroenterology, PA Austin Texas 78745
Atilla Ertan, MD, PA Houston Texas 77030
Gastroenterology Clinic of San Antonio, P.A. San Antonio Texas 78229
Wasatch Clinical Research Salt Lake City Utah 84107
UVA Health System Charlottesville Virginia 22908
Gastroenterology Associates of Tidewater Chesapeake Virginia 23320
Internal Medicine Associates Danville Virginia 24541
McGuire DVAMC GI (111N) Richmond Virginia 23249
Virginia Mason Medical Center Seattle Washington 98101
Tacoma Digestive Disease Research Center Tacoma Washington 98405
Aurora Helath Care Milwaukee Wisconsin 53215
Medical College of Wisconsin Milwaukee Wisconsin 53226

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 12 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00078611, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 15, 2016 · Synced May 20, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00078611 live on ClinicalTrials.gov.

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