Crohn's DiseasePhase 2NCT00055523
A Study of the Human Anti-TNF Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease
A Phase 2 study testing Adalimumab (D2E7) in people with Crohn's Disease, run by Abbott at 43 sites in United States.
Trial summary
Purpose of the study is to test whether adalimumab can induce clinical remission in subjects with active Crohn's disease when compared to placebo (an inactive substance) 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 (D2E7)
- How many people
- 300 participants
- Where
- 43 sitesUnited States
- Study dates
- Apr 2002to not given
- Phase
- Phase 2
- 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
- Diagnosis of Crohn's disease
- CDAI score at baseline of between 220 and 450
- Normal laboratory parameters
- Willing and able to give informed consent
Who cannot join
- Diagnosis of ulcerative colitis
- Women cannot be pregnant or breastfeeding
- No previous use of infliximab or other anti-TNF antagonists
- No previous history of tuberculosis or listeria infection
- No previous history of cancer other than successfully treated skin cancer
Trial locations and contacts
43 sites in 1 country.
43 sites in 1 country
United States43 sites
Digestive Disorders Associates
Annapolis, Maryland, 21401
Northwest Gastroenterologists, S.C.
Arlington Heights, Illinois, 600005
Atlanta Gastroenterology Assoc.
Atlanta, Georgia, 30342
Northwest Gastroenterology
Bellevue, Washington, 98004
Gastroenterology Associates of the East Bay
Berkeley, California, 94705
Deaconess Billings Clinic Research Division
Billings, Montana, 59101
Brigham and Women's Hospital
Boston, Massachusetts, 002115
Massachusetts General Hospital
Boston, Massachusetts, 02114
Gastroenterology Assoc. of Fairfield Co.
Bridgeport, Connecticut, 06606
UNC School of Medicine
Chapel Hill, North Carolina, 27599
Charlotte Gastroenterology and Hepatology
Charlotte, North Carolina, 28207
Carolina Research Associates
Charlotte, North Carolina, 28262
Charlottesville Medical Research
Charlottesville, Virginia, 22902
Diseases of the Digestive System
Chattanooga, Tennessee, 37421
University of Chicago
Chicago, Illinois, 60637
Consultants for Clinical Research
Cincinnati, Ohio, 45219
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Long Island Clinical Research Associates
Great Neck, New York, 11021
Gastroenterology and Hepatology
Kansas City, Missouri, 64131
NY Center for Clinical Research
Lake Success, New York, 11042
Gastroenterology Specialties, P.C.
Lincoln, Nebraska, 68503
Long Beach Gastroenterology Assoc.
Long Beach, California, 90806
Drug Research Services, Inc.
Metairie, Louisiana, 70001
Glenn Gordon, MD
Mexico, Missouri, 65265
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53702
Nashville Medical Research Institute
Nashville, Tennessee, 37205
LSU School of Medicine
New Orleans, Louisiana, 70115
New York Presbyterian Hospital
New York, New York, 10021
Daniel Present
New York, New York, 10029
Oklahoma Foundation for Digestive Disease
Oklahoma City, Oklahoma, 73104
Peter Molloy, MD
Pittsburgh, Pennsylvania, 15224
Wake Research Associates
Raleigh, North Carolina, 27612
Mayo Clinic and Mayo Foundation
Rochester, Minnesota, 55905
Rochester Institute for Digestive Diseases
Rochester, New York, 14607
Sharp Rees-Stealy Medical Group
San Diego, California, 92123
Southeastern Digestive & Liver Disease
Savannah, Georgia, 31404
Inland Empire Gastroenterology
Spokane, Washington, 99204
Tacoma Digestive Disease Center
Tacoma, Washington, 98405
Research Solutions
Tulsa, Oklahoma, 74104
Cleveland Clinic Florida
Weston, Florida, 33331
Digestive Health Specialists
Winston-Salem, North Carolina, 27103
Shafran Gastroenterology Center
Winter Park, Florida, 32789
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01610
About this study
Official title: A Phase II Study of the Human Anti-TNF Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease
Purpose of the study is to test whether adalimumab can induce clinical remission in subjects with active Crohn's disease when compared to placebo (an inactive substance)
- Conditions
- Crohn's Disease
- Being tested
- Adalimumab (D2E7)
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adalimumab (D2E7)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of the induction of clinical remission
(achievement of a CDAI <150) of adalimumab 40 mg and 80 mg vs. placebo 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 posted6 Mar 2003 (estimated)
- Study startApr 2002
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Stephen B Hanauer, MD, Principal investigator, University of Chicago Department of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00055523
- Sponsor's protocol ID
- M02-403
- Status last verified
- Aug 2006
- First submitted
- 4 Mar 2003
- Last updated
- 15 Aug 2006
- Results posted
- No
Publications
Steenholdt C, Al-khalaf M, Brynskov J, Bendtzen K, Thomsen OO, Ainsworth MA. Clinical implications of variations in anti-infliximab antibody levels in patients with inflammatory bowel disease. Inflamm Bowel Dis. 2012 Dec;18(12):2209-17. doi: 10.1002/ibd.22910. Epub 2012 Feb 16.
PubMed 22344964
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 Phase II Study of the Human Anti-TNF Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease
- ClinicalTrials.gov ID
- NCT00055523
- Acronym / sponsor ID
- M02-403
- Conditions
- Crohn's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Apr 2002
- First posted
- 6 Mar 2003 (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.
Purpose of the study is to test whether adalimumab can induce clinical remission in subjects with active Crohn's disease when compared to placebo (an inactive substance)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- 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)
- Diagnosis of Crohn's disease
- CDAI score at baseline of between 220 and 450
- Normal laboratory parameters
- Willing and able to give informed consent
Key exclusion criteria (5 listed)
- Diagnosis of ulcerative colitis
- Women cannot be pregnant or breastfeeding
- No previous use of infliximab or other anti-TNF antagonists
- No previous history of tuberculosis or listeria infection
- No previous history of cancer other than successfully treated skin cancer
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 (D2E7) | Drug | – |
Primary outcome
comparison of the induction of clinical remission
(achievement of a CDAI <150) of adalimumab 40 mg and 80 mg vs. placebo 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 22344964Steenholdt C, Al-khalaf M, Brynskov J, Bendtzen K, Thomsen OO, Ainsworth MA. Clinical implications of variations in anti-infliximab antibody levels in patients with inflammatory bowel disease. Inflamm Bowel Dis. 2012 Dec;18(12):2209-17. doi: 10.1002/ibd.22910. Epub 2012 Feb 16.
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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.
Stephen B Hanauer, MD principal investigator
University of Chicago Department of Medicine
43 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adalimumab (D2E7) in people with Crohn's Disease, run by Abbott at 43 sites in United States.
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 5 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 43 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
comparison of the induction of clinical remission. The study lists 2 primary outcomes in all. 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 NCT00055523, 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.