Crohn's DiseasePhase 3NCT00078611
A Clinical Trial of Natalizumab in Individuals With Moderately to Severely Active Crohn's Disease
A Phase 3 study testing natalizumab in people with Crohn's Disease, run by Biogen at 75 sites in 2 countries.
Trial summary
The purpose of this trial is to evaluate natalizumab in individuals with moderately to severely active Crohn's Disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- natalizumab
- How many people
- 462 participants
- Where
- 75 sitesin 2 countries
- Study dates
- Mar 2004to Mar 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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
Trial locations and contacts
75 sites in 2 countries.
75 sites in 2 countries
United States63 sites
Advanced Clinical Research Institute
Anaheim, California, 92801
Asheville Gastroenterology Associates
Asheville, North Carolina, 28801
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342
Austin Gastroenterology, PA
Austin, Texas, 78745
University of North Carolina
Chapel Hill, North Carolina, 27599
Medical University of South Carolina - Digestive Disease Center
Charleston, South Carolina, 29425
Charlotte Gastroenterology & Hepatology, PLLC.
Charlotte, North Carolina, 28207
UVA Health System
Charlottesville, Virginia, 22908
Southeastern Clinical Research
Chattanooga, Tennessee, 37403
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320
Metropolitan Gastroenterology Group, PC / Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815
University of Chicago Hospitals
Chicago, Illinois, 60637
Consultants for Clinical Research, Inc.
Cincinnati, Ohio, 45219
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Lynn Institute of the Rockies
Colorado Springs, Colorado, 80909
Internal Medicine Associates
Danville, Virginia, 24541
Malcolm Randall VA Medical Center
Gainesville, Florida, 32608
Rocky Mountain Gastroenterology
Golden, Colorado, 80215
Long Island Clinical Research Associates, LLP
Great Neck, New York, 11021
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Atilla Ertan, MD, PA
Houston, Texas, 77030
Outpatient Clinical Research Facility
Indianapolis, Indiana, 46202-5250
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, 46227
Borland Groover Clinic
Jacksonville, Florida, 32256
New York Center for Clinical Research
Lake Success, New York, 11042
University of Kentucky Medical Center
Lexington, Kentucky, 40536
Arapahoe Gastroenterology
Littleton, Colorado, 80120
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
University of Louisville
Louisville, Kentucky, 40202
Center for Medical Research, LLC
Manchester, Connecticut, 06040
Gastroenterology Center of the Midsouth, P.C.
Memphis, Tennessee, 38120
Summit Research Solutions
Memphis, Tennessee, 38120
Drug Research Service, Inc.
Metairie, Louisiana, 70001
Miami Research Associates, Inc.
Miami, Florida, 33173
Aurora Helath Care
Milwaukee, Wisconsin, 53215
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Nashville Medical Research Institute
Nashville, Tennessee, 37205
Mount Sinai School of Medicine
New York, New York, 10028
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, 73104
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
Community Clinical Trials
Orange, California, 92868
Harmony Clinical Research
Oro Valley, Arizona, 85739
Allegheny Center for Digestive Health
Pittsburgh, Pennsylvania, 15212
Minnesota Gastroenterology, P.A.
Plymouth, Minnesota, 55446
Gastroenterology Associates
Providence, Rhode Island, 02904
Wake Research Associates
Raleigh, North Carolina, 27612
McGuire DVAMC GI (111N)
Richmond, Virginia, 23249
Mayo Clinic
Rochester, Minnesota, 55905
Rochester Institute for Digestive Diseases and Sciences, Inc.
Rochester, New York, 14607
Wasatch Clinical Research
Salt Lake City, Utah, 84107
Gastroenterology Clinic of San Antonio, P.A.
San Antonio, Texas, 78229
UCSF / Mt. Zion IBD Center
San Francisco, California, 94115
Virginia Mason Medical Center
Seattle, Washington, 98101
Tacoma Digestive Disease Research Center
Tacoma, Washington, 98405
Shared Medical Research Foundation
Tarzana, California, 91356
Advanced Clinical Therapeutics
Tucson, Arizona, 85712
Oklahoma Gastroenterology Associates
Tulsa, Oklahoma, 74104
Morowitz, Marion, Laessing, Shocket, Bashir, Steinberg, Salcedo
Washington D.C., District of Columbia, 20010
Waterside Clinical Research Services, Inc.
West Palm Beach, Florida, 33407
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27012
Shafran Gastroenterology Center
Winterpark, Florida, 32789
Canada12 sites
University of Calgary
Calgary, Alberta, T2N 4N1
GI Research
Edmonton, Alberta, T5H 4B9
University of Alberta
Edmonton, Alberta, T6G 2C8
Queen Elizabeth II Science Center
Halifax, Nova Scotia, B3H 1V7
McMaster University Medical Centre
Hamilton, Ontario, L8N 3Z5
Montreal General Hospital
Montreal, Quebec, H3G 1A4
Chauq Hopital Du St. Sacrement
Québec, Quebec, G1S 4L8
Sunnybrook & Women's College Health Sciences Center
Toronto, Ontario, M4N 3M5
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Liver and Intestinal Research Centre
Vancouver, British Columbia, V5Z 1H2
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Health Sciences Center
Winnipeg, Manitoba, R3A 1R9
About this study
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
The purpose of this trial is to evaluate natalizumab in individuals with moderately to severely active Crohn's Disease.
Read the 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.
- Conditions
- Crohn's Disease
- Being tested
- natalizumab
- Keywords
- Crohn's disease, Inflammatory Bowel Disease, IBD, Gastroenterology, Regional Enteritis, Colitis
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases, Colitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
natalizumabDrug
Also called Antegren
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2004 (estimated)
- Study startMar 2004
- Primary completionMar 2005
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 462 participants
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Elan Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00078611
- Sponsor's protocol ID
- ELN100226-CD307
- Status last verified
- Mar 2012
- First submitted
- 1 Mar 2004
- Last updated
- 16 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00078611
- Acronym / sponsor ID
- ELN100226-CD307
- Conditions
- Crohn's Disease
- Keywords
- Crohn's disease, Inflammatory Bowel Disease, IBD, Gastroenterology, Regional Enteritis, Colitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 462 participants
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Collaborators
- Elan Pharmaceuticals
- Study start
- Mar 2004
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 8 Mar 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| natalizumabAlso: Antegren | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2016.
Related trials for Crohn's Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
75 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing natalizumab in people with Crohn's Disease, run by Biogen at 75 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 75 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2016.