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Crohn's DiseasePhase 3CHARMNCT00077779

Adalimumab for the Induction and Maintenance 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 43 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 purpose of this study is to test whether Adalimumab (at two different doses) can induce and maintain clinical remission in subjects with active Crohn's disease when compared to placebo (a substance containing no medication) 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
854 participants
Where
43 sitesUnited States
Study dates
Jul 2003to 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 moderate to severe Crohn's Disease defined by a CDAI score of >= 220 and <= 450, normal laboratory parameters,
  • are willing and able to give informed consent, and
  • are able to self-inject or have a designee or healthcare professional who can inject the study medication.

Who cannot join

  • History of certain types of cancer, diagnosis of ulcerative colitis,
  • female or breast feeding subjects,
  • surgical bowel resection(s) with in the past 6 months,
  • history of listeria,
  • human immunodeficiency virus (HIV),
  • central nervous system demyelinating disease or untreated TB,
  • history of a poorly controlled medical condition,
  • unsuccessful response to infliximab or any anti-TNF agent use in the past.

Trial locations and contacts

43 sites in 1 country.

43 sites in 1 country

United States43 sites

  • Maryland Clinical Trials

    Annapolis, Maryland, 21401

  • Northwest Gastroenterology

    Arlington Heights, Illinois, 60005

  • Western States Clinical Research

    Arvada, Colorado, 80002

  • Gastroenterology Associates of Fairfield County

    Bridgeport, Connecticut, 06606

  • Charlotte Gastroenterology & Hepatology

    Charlotte, North Carolina, 28207

  • Carolina Digestive Health Associates

    Charlotte, North Carolina, 28211

  • Carolina Research Associates

    Charlotte, North Carolina, 28262

  • Chevy Chase Clinical Research

    Chevy Chase, Maryland, 20815

  • Northwestern University

    Chicago, Illinois, 60611

  • The University of Chicago

    Chicago, Illinois, 60637

  • Clinical Research of West Florida, Inc.

    Clearwater, Florida, 33765

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • Columbia Gastro Associates

    Columbia, South Carolina, 29204

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635

  • V.A. Medical Center

    Gainsville, Florida, 32608

  • Long Island Clinical Research Assoc.

    Great Neck, New York, 11021

  • Le Bauer Research, P.A.

    Greensboro, North Carolina, 27403

  • Mark Lamet, MD

    Hollywood, Florida, 33021

  • Indianapolis Gastroenterology Research Foundation

    Indianapolis, Indiana, 46237

  • St. Vincent Hospital: Research Department

    Indianapolis, Indiana, 46260

  • Gastroenterology & Hematology

    Kansas City, Missouri, 64131

  • Thornton Hospital Reumatology Division

    La Jolla, California, 92037-0943

  • NY Center for Clinical Research

    Lake Success, New York, 11042

  • Gastroenterology Center of the Mid South

    Memphis, Tennessee, 38120

  • Drug Research Services, Inc.

    Metairie, Louisiana, 70001

  • Glenn Gordon, MD

    Mexico, Missouri, 65265

  • Discovery Research Inteternational, LLC

    Milwaukee, Wisconsin, 53215

  • Wisconsin Center for Advanced Research

    Milwaukee, Wisconsin, 53215

  • Nashville Medical Research

    Nashville, Tennessee, 37205

  • Daniel Present, MD

    New York, New York, 10029

  • Gastroenterology Consultants

    Ormond Beach, Florida, 32174

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15261

  • Digestive Disease Associates of Rockland

    Pomona, New York, 10970

  • Westhills Gastroenterology

    Portland, Oregon, 98112

  • Gastrointestinal Specialists

    Richmond, Virginia, 23230

  • Mayo Clinic Research

    Rochester, Minnesota, 55905-0002

  • UCSF San Francisco General Hospital

    San Francisco, California, 94110

  • Cal-West, Inc.

    San Francisco, California, 94117

  • Capital Gastroenterology Consultants, P.A.

    Silver Spring, Maryland, 20901

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Washington University School

    St Louis, Missouri, 63110

  • Wilmington Gastroenterology

    Wilmington, North Carolina, 28401

  • Clinical Pharmacology Study Group

    Worcester, Massachusetts, 01610

Other trials in United States

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 and Maintenance of Clinical Remission in Subjects With Crohn's Disease

The purpose of this study is to test whether Adalimumab (at two different doses) can induce and maintain clinical remission in subjects with active Crohn's disease when compared to placebo (a substance containing no medication)

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. Clinical remission (CDAI<150).

    Measured: 56 weeks

Timeline

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

  1. First posted16 Feb 2004 (estimated)
  2. Study startJul 2003

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
854 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00077779
Sponsor's protocol ID
M02-404
Acronym
CHARM
Status last verified
Sep 2007
First submitted
12 Feb 2004
Last updated
26 Sep 2007
Results posted
No

Publications

  • Sandborn WJ, Lewis JD, Panes J, Loftus EV, D'Haens G, Yu Z, Huang B, Lacerda AP, Pangan AL, Feagan BG. Association Between Proposed Definitions of Clinical Remission/Response and Well-Being in Patients With Crohn's Disease. J Crohns Colitis. 2022 Mar 14;16(3):444-451. doi: 10.1093/ecco-jcc/jjab161.

    PubMed 34546360

  • Ryan C, Sobell JM, Leonardi CL, Lynde CW, Karunaratne M, Valdecantos WC, Hendrickson BA. Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis. Am J Clin Dermatol. 2018 Jun;19(3):437-447. doi: 10.1007/s40257-017-0341-6.

    PubMed 29380251

  • Panaccione R, Colombel JF, Sandborn WJ, D'Haens G, Zhou Q, Pollack PF, Thakkar RB, Robinson AM. Adalimumab maintains remission of Crohn's disease after up to 4 years of treatment: data from CHARM and ADHERE. Aliment Pharmacol Ther. 2013 Nov;38(10):1236-47. doi: 10.1111/apt.12499. Epub 2013 Sep 22.

    PubMed 24134498

  • Schreiber S, Reinisch W, Colombel JF, Sandborn WJ, Hommes DW, Robinson AM, Huang B, Lomax KG, Pollack PF. Subgroup analysis of the placebo-controlled CHARM trial: increased remission rates through 3 years for adalimumab-treated patients with early Crohn's disease. J Crohns Colitis. 2013 Apr;7(3):213-21. doi: 10.1016/j.crohns.2012.05.015. Epub 2012 Jun 16.

    PubMed 22704916

  • Kamm MA, Hanauer SB, Panaccione R, Colombel JF, Sandborn WJ, Pollack PF, Zhou Q, Robinson AM. Adalimumab sustains steroid-free remission after 3 years of therapy for Crohn's disease. Aliment Pharmacol Ther. 2011 Aug;34(3):306-17. doi: 10.1111/j.1365-2036.2011.04717.x. Epub 2011 Jun 5.

    PubMed 21645018

  • Colombel JF, Schwartz DA, Sandborn WJ, Kamm MA, D'Haens G, Rutgeerts P, Enns R, Panaccione R, Schreiber S, Li J, Kent JD, Lomax KG, Pollack PF. Adalimumab for the treatment of fistulas in patients with Crohn's disease. Gut. 2009 Jul;58(7):940-8. doi: 10.1136/gut.2008.159251. Epub 2009 Feb 6.

    PubMed 19201775

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 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 3 inclusion and 8 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 26 Sep 2007. 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 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?

Clinical remission (CDAI<150). (time frame: 56 weeks). 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 NCT00077779, which also lists 6 linked publications.

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 26 Sep 2007.

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