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Crohn's DiseasePhase 3NCT00338650

Treatment of the Human Anti-TNF Monoclonal Antibody Adalimumab in Moderate to Severe Crohn's Disease With Previous Exposure to Infliximab (CHOICE)

A Phase 3 study testing adalimumab in people with Crohn's Disease, run by Abbott at 97 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of this study is to make adalimumab available to patients suffering from moderately to severely active Crohn's Disease who have failed to respond to, lost response to, or are intolerant to infliximab, and to evaluate safety 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
1,000 participants
Where
97 sitesUnited States
Study dates
Jun 2006to May 2007
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

  • Patient diagnosed with moderate to severe Crohn's Disease.
  • Failed prior infliximab therapy.
  • Patient is judged to be in generally good health as determined by the principal investigator.

Who cannot join

  • Previous treatment with adalimumab.
  • Patient considered by the investigator, for any reason, to be an unsuitable candidate

Trial locations and contacts

97 sites in 1 country.

97 sites in 1 country

United States97 sites

  • Study site

    Annapolis, Maryland, 21401

  • Study site

    Arlington Heights, Illinois, 60005

  • Study site

    Atlanta, Georgia, 30308

  • Study site

    Atlanta, Georgia, 30309

  • Study site

    Atlanta, Georgia, 30342

  • Study site

    Austin, Texas, 78745

  • Study site

    Beachwood, Ohio, 44122

  • Study site

    Beaver Falls, Pennsylvania, 15010

  • Study site

    Bellevue, Washington, 98004

  • Study site

    Birmingham, Alabama, 35209

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Boston, Massachusetts, 02118

  • Study site

    Bridgeport, Connecticut, 06606

  • Study site

    Burlington, Massachusetts, 01805

  • Study site

    Charlotte, North Carolina, 28207

  • Study site

    Charlotte, North Carolina, 28211

  • Study site

    Chattanooga, Tennessee, 37403

  • Study site

    Chattanooga, Tennessee, 37404

  • Study site

    Chevy Chase, Maryland, 20815

  • Study site

    Cincinnati, Ohio, 45219

  • Study site

    Cincinnati, Ohio, 45220

  • Study site

    Cincinnati, Ohio, 45242

  • Study site

    Clearwater, Florida, 33765

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Clive, Iowa, 50325

  • Study site

    Columbia, South Carolina, 29204

  • Study site

    Columbus, Indiana, 47201

  • Study site

    Conyers, Georgia, 30012

  • Study site

    Davenport, Iowa, 52807

  • Study site

    Duncansville, Pennsylvania, 16635

  • Study site

    Egg Harbor, New Jersey, 08234

  • Study site

    Englewood, Colorado, 80113

  • Study site

    Gainesville, Florida, 32607

  • Study site

    Gainesville, Florida, 32610

  • Study site

    Germantown, Tennessee, 38138

  • Study site

    Glen Ridge, New Jersey, 07028

  • Study site

    Great Neck, New York, 11021

  • Study site

    Hamden, Connecticut, 06518

  • Study site

    Hollywood, Florida, 33021

  • Study site

    Indianapolis, Indiana, 46202-5250

  • Study site

    Indianapolis, Indiana, 46237

  • Study site

    Jacksonville, Florida, 32224

  • Study site

    Jacksonville, Florida, 32256

  • Study site

    Jacksonville, North Carolina, 28546

  • Study site

    Jonesboro, Arkansas, 72401

  • Study site

    Kansas City, Missouri, 64131

  • Study site

    Lake Success, New York, 11042

  • Study site

    Lebanon, New Hampshire, 03756

  • Study site

    Lexington, Kentucky, 40536

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Lutherville, Maryland, 21093

  • Study site

    Manalapan, New Jersey, 07726

  • Study site

    Marietta, Georgia, 30060

  • Study site

    Mexico, Missouri, 65265-3726

  • Study site

    Miami, Florida, 33173

  • Study site

    Milwaukee, Wisconsin, 53215

  • Study site

    Milwaukee, Wisconsin, 53226

  • Study site

    Milwaukee, Wisconsin, 53233

  • Study site

    Moline, Illinois, 61265

  • Study site

    Monroe, Wisconsin, 53566

  • Study site

    New York, New York, 10021

  • Study site

    New York, New York, 10022

  • Study site

    New York, New York, 10028

  • Study site

    New York, New York, 10128

  • Study site

    Norfolk, Virginia, 23502

  • Study site

    North Miami Beach, Florida, 33162

  • Study site

    Overland Park, Kansas, 66212

  • Study site

    Philadelphia, Pennsylvania, 19107

  • Study site

    Picayune, Mississippi, 39466

  • Study site

    Pittsburgh, Pennsylvania, 15224

  • Study site

    Pittsburgh, Pennsylvania, 15232

  • Study site

    Pittsburgh, Pennsylvania, 15243

  • Study site

    Plymouth, Minnesota, 55446

  • Study site

    Portland, Oregon, 97220

  • Study site

    Portland, Oregon, 97225

  • Study site

    Rochester, New York, 14607

  • Study site

    Rockford, Illinois, 61107

  • Study site

    Rocky Mount, North Carolina, 27804

  • Study site

    Roseville, California, 95661

  • Study site

    San Francisco, California, 94115

  • Study site

    Savannah, Georgia, 31405

  • Study site

    Sayre, Pennsylvania, 18840

  • Study site

    Seattle, Washington, 98101

  • Study site

    Silver Spring, Maryland, 20901

  • Study site

    South Ogden, Utah, 84405

  • Study site

    Spokane, Washington, 99204

  • Study site

    St Louis, Missouri, 63128

  • Study site

    Topeka, Kansas, 66606

  • Study site

    Troy, Michigan, 48098

  • Study site

    Tulsa, Oklahoma, 74104

  • Study site

    Tulsa, Oklahoma, 74135

  • Study site

    Vancouver, Washington, 98664

  • Study site

    Warren, Ohio, 44484

  • Study site

    Wheat Ridge, Colorado, 80033

  • Study site

    Wilmington, North Carolina, 28401

  • Study site

    Wilmington, North Carolina, 28403

  • Study site

    Winter Park, Florida, 32789

Other trials in United States

About this study

Official title: A Multi-Center, Open-Label Treatment Protocol of the Human Anti-TNF Monoclonal Antibody Adalimumab in Patients With Moderate to Severe Crohn's Disease With Previous Exposure to Infliximab

The primary objective of this study is to make adalimumab available to patients suffering from moderately to severely active Crohn's Disease who have failed to respond to, lost response to, or are intolerant to infliximab, and to evaluate safety

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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AEs, laboratory data, physical examinations and vital signs

Secondary outcomes (1)

  1. Efficacy variables will be assessed from Outcomes Questionnaires

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2006 (estimated)
  2. Study startJun 2006
  3. Study completionMay 2007

Resources

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
1,000 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00338650
Sponsor's protocol ID
M06-808
Other IDs
CHOICE
Status last verified
Nov 2007
First submitted
19 Jun 2006
Last updated
29 Nov 2007
Results posted
No

Publications

  • Lichtiger S, Binion DG, Wolf DC, Present DH, Bensimon AG, Wu E, Yu AP, Cardoso AT, Chao J, Mulani PM, Lomax KG, Kent JD. The CHOICE trial: adalimumab demonstrates safety, fistula healing, improved quality of life and increased work productivity in patients with Crohn's disease who failed prior infliximab therapy. Aliment Pharmacol Ther. 2010 Nov;32(10):1228-39. doi: 10.1111/j.1365-2036.2010.04466.x. Epub 2010 Sep 28.

    PubMed 20955442

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 97 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 3 inclusion and 2 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 29 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 97 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 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?

AEs, laboratory data, physical examinations and vital signs. 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 NCT00338650, 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 29 Nov 2007.

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