Crohn's DiseasePhase 3NCT00105300
Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease
A Phase 3 study testing Adalimumab in people with Crohn's Disease, run by Abbott at 56 sites in 4 countries.
Trial summary
The goal of this study is to test whether adalimumab can induce clinical remission in subjects with active Crohn's disease who have been initially treated with infliximab and either lost response or discontinued its use as a result of intolerance to the drug. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Adalimumab
- How many people
- 300 participants
- Where
- 56 sitesin 4 countries
- Study dates
- Oct 2004to not given
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females between the ages of 18 and 75 who are diagnosed with mild to moderate Crohn's disease (defined by a CDAI [Crohn's Disease Activity Index] score of 220 and 450)
- Normal lab parameters
- Are willing to give informed consent
- Have previously used and either were intolerant to or lost response to infliximab
Who cannot join
- History of certain types of cancer
- Diagnosis of ulcerative colitis
- Pregnant female or breast feeding subjects
- Known obstructive strictures
- Surgical bowel resection in the past 6 months
- History of listeria, human immunodeficiency virus (HIV), central nervous system demyelinating disease or untreated TB (tuberculosis)
Show all 9Show fewer
- History of poorly controlled medical conditions
- Specific doses and durations of Crohn's medications
- Subjects that have previously used infliximab and have never clinically responded unless primary non-response was due to a treatment limiting reaction to infliximab
Trial locations and contacts
56 sites in 4 countries.
56 sites in 4 countries
United States46 sites
Asheville Gastroenterology Associates
Ashville, North Carolina, 28801
Pinnacle Trials, Inc.
Atlanta, Georgia, 30329
Atlanta Gastroenterology Assoc.
Atlanta, Georgia, 30342
Austin Gastroenterology
Austin, Texas, 78745
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815
The University of Chicago
Chicago, Illinois, 60673
Consultants for Clinical Research
Cincinnati, Ohio, 45219
Clinical Research of West Florida, Inc
Clearwater, Florida, 33765
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Columbia Gastro Associates
Columbia, South Carolina, 29204
Internal Medicine Associates
Danville, Virginia, 25451
Gastrointestinal and Liver Disease Consultants
Dayton, Ohio, 45440
Atlantic Gastroenterology Associates, LLC
Egg Harbor, New Jersey, 08234
SMC-Trauma Research
Englewood, Colorado, 80113
V.A. Medical Center
Gainesville, Florida, 32608
Long Island Clinical Research Assoc. LLP
Great Neck, New York, 11021
Clinical Research Associates
Huntsville, Alabama, 35801
Outpatient Clinical Research Facility University of Indianapolis
Indianapolis, Indiana, 462025250
Gastrointestinal Associated, P.A.
Jackson, Mississippi, 39202
Borland-Groover Clinic
Jacksonville, Florida, 32256
Gastrointestinal Associates
Knoxville, Tennessee, 37909
NY Center for Clinical Research
Lake Success, New York, 11042
Regional Gastroenterologist Associates of Lancaster
Lancaster, Pennsylvania, 17604
University of Kentucky Medical Center Division of Digestive Diseases
Lexington, Kentucky, 40536
Gastroenterology Associates of Cleveland
Mayfield Heights, Ohio, 44124
Gastroenterology Center of the Mid South
Memphis, Tennessee, 38120
Drug Research Services, Inc.
Metairie, Louisiana, 70001
Glen Gordon, MD
Mexico, Missouri, 65265
Discovery Research International, LLC
Milwaukee, Wisconsin, 53207
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Mount Sinai School of Medicine IBD Research Center
New York, New York, 10029
Digestive and Liver Disease
Norfolk, Virginia, 23205
Ntouch Research
Peoria, Illinois, 60602
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15261
Minnesota Gastroenterology P.A.
Plymouth, Minnesota, 55446
The Oregon Clinic, PC Gastroenterology Division
Portland, Oregon, 97220
Wake Research Associates
Raleigh, North Carolina, 27612
Mayo Clinic Research
Rochester, Minnesota, 559050002
Capitol Gastroenterology Consultants Medical Group, Inc.
Roseville, California, 95661
Wasatch Clinical Research
Salt Lake City, Utah, 84107
Medical Associates Research Group
San Diego, California, 92123
Sharp Rees-Stealy Medical Group
San Diego, California, 92123
Spokane Digestive Disease Center
Spokane, Washington, 99204
St. Louis Center for Clinical Research
St Louis, Missouri, 63128
Charm City Research
Towson, Maryland, 21204
Shafran Gastroenterology Center
Winter Park, Florida, 32789
Canada7 sites
Heritage Medical Research Clinic Health Sciences Centre University of Calgary
Calgary, Alberta, T2N 4N1
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 1V7
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1
Toronto Digestive Disease Assoc. Inc
Toronto, Ontario, M3N 2V7
Liver and Intestinal Disease Research Center
Vancouver, British Columbia, V5Z 1H2
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Winnipeg Health Sciences Centre
Winnipeg, Manitoba, R3A 1R9
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Moderate to Severe Crohn's Disease Who Have Lost Response or Are Intolerant to Infliximab
The goal of this study is to test whether adalimumab can induce clinical remission in subjects with active Crohn's disease who have been initially treated with infliximab and either lost response or discontinued its use as a result of intolerance to the drug.
- Conditions
- Crohn's Disease
- Being tested
- Adalimumab
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Induction of clinical remission (CDAI score < 150 at Week 4)
Secondary outcomes (4)
Clinical response measured as
Decrease in Baseline CDAI score >= 70 points at Week 4
Decrease in Baseline CDAI score >= 100 points at Week 4
Changes in IBDQ scores at Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2005 (estimated)
- Study startOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- 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
- 300 participants
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Medical Information 1-800-633-9110, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00105300
- Sponsor's protocol ID
- M04-691
- Status last verified
- Aug 2006
- First submitted
- 11 Mar 2005
- Last updated
- 15 Aug 2006
- Results posted
- No
Publications
Sandborn WJ, Rutgeerts P, Enns R, Hanauer SB, Colombel JF, Panaccione R, D'Haens G, Li J, Rosenfeld MR, Kent JD, Pollack PF. Adalimumab induction therapy for Crohn disease previously treated with infliximab: a randomized trial. Ann Intern Med. 2007 Jun 19;146(12):829-38. doi: 10.7326/0003-4819-146-12-200706190-00159. Epub 2007 Apr 30.
PubMed 17470824
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Moderate to Severe Crohn's Disease Who Have Lost Response or Are Intolerant to Infliximab
- ClinicalTrials.gov ID
- NCT00105300
- Acronym / sponsor ID
- M04-691
- Conditions
- Crohn's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- First posted
- 14 Mar 2005 (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 goal of this study is to test whether adalimumab can induce clinical remission in subjects with active Crohn's disease who have been initially treated with infliximab and either lost response or discontinued its use as a result of intolerance to the drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females between the ages of 18 and 75 who are diagnosed with mild to moderate Crohn's disease (defined by a CDAI [Crohn's Disease Activity Index] score of 220 and 450)
- Normal lab parameters
- Are willing to give informed consent
- Have previously used and either were intolerant to or lost response to infliximab
Key exclusion criteria (9 listed)
- History of certain types of cancer
- Diagnosis of ulcerative colitis
- Pregnant female or breast feeding subjects
- Known obstructive strictures
- Surgical bowel resection in the past 6 months
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 |
|---|---|---|
| Adalimumab | Drug | – |
Primary outcome
Induction of clinical remission (CDAI score < 150 at Week 4)
4 secondary outcomes
Clinical response measured as
Decrease in Baseline CDAI score >= 70 points at Week 4
Decrease in Baseline CDAI score >= 100 points at Week 4
Changes in IBDQ scores at Week 4
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 15 Aug 2006.
- Derived from this study: PubMed 17470824Sandborn WJ, Rutgeerts P, Enns R, Hanauer SB, Colombel JF, Panaccione R, D'Haens G, Li J, Rosenfeld MR, Kent JD, Pollack PF. Adalimumab induction therapy for Crohn disease previously treated with infliximab: a randomized trial. Ann Intern Med. 2007 Jun 19;146(12):829-38. doi: 10.7326/0003-4819-146-12-200706190-00159. Epub 2007 Apr 30.
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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.
Global Medical Information 1-800-633-9110 study director
Abbott
56 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adalimumab in people with Crohn's Disease, run by Abbott at 56 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. 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 15 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United States, Canada, Belgium, France. 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.
What does the primary outcome measure?
Induction of clinical remission (CDAI score < 150 at Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00105300, which also lists 1 linked publication.
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 15 Aug 2006.