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Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease (CHARM)

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Adalimumab
Sponsored by
Abbott
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion: 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. Exclusion: 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.

Sites / Locations

  • Thornton Hospital Reumatology Division
  • UCSF San Francisco General Hospital
  • Cal-West, Inc.
  • Western States Clinical Research
  • Gastroenterology Associates of Fairfield County
  • Clinical Research of West Florida, Inc.
  • V.A. Medical Center
  • Mark Lamet, MD
  • Gastroenterology Consultants
  • Northwest Gastroenterology
  • Northwestern University
  • The University of Chicago
  • Indianapolis Gastroenterology Research Foundation
  • St. Vincent Hospital: Research Department
  • Drug Research Services, Inc.
  • Maryland Clinical Trials
  • Chevy Chase Clinical Research
  • Capital Gastroenterology Consultants, P.A.
  • Clinical Pharmacology Study Group
  • Mayo Clinic Research
  • Gastroenterology & Hematology
  • Glenn Gordon, MD
  • Washington University School of Medicine
  • Washington University School
  • Long Island Clinical Research Assoc.
  • NY Center for Clinical Research
  • Daniel Present, MD
  • Digestive Disease Associates of Rockland
  • Charlotte Gastroenterology & Hepatology
  • Carolina Digestive Health Associates
  • Carolina Research Associates
  • Le Bauer Research, P.A.
  • Wilmington Gastroenterology
  • University Hospitals of Cleveland
  • Westhills Gastroenterology
  • Altoona Center for Clinical Research
  • University of Pittsburgh Medical Center
  • Columbia Gastro Associates
  • Gastroenterology Center of the Mid South
  • Nashville Medical Research
  • Gastrointestinal Specialists
  • Discovery Research Inteternational, LLC
  • Wisconsin Center for Advanced Research

Outcomes

Primary Outcome Measures

Clinical remission (CDAI<150).

Secondary Outcome Measures

Full Information

First Posted
February 12, 2004
Last Updated
September 23, 2007
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00077779
Brief Title
Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease
Acronym
CHARM
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott

4. Oversight

5. Study Description

Brief 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
854 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Adalimumab
Primary Outcome Measure Information:
Title
Clinical remission (CDAI<150).
Time Frame
56 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion: 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. Exclusion: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul F Pollack, M.D.
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Thornton Hospital Reumatology Division
City
La Jolla
State/Province
California
ZIP/Postal Code
92037-0943
Country
United States
Facility Name
UCSF San Francisco General Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Cal-West, Inc.
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
Facility Name
Western States Clinical Research
City
Arvada
State/Province
Colorado
ZIP/Postal Code
80002
Country
United States
Facility Name
Gastroenterology Associates of Fairfield County
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
Clinical Research of West Florida, Inc.
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
V.A. Medical Center
City
Gainsville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Mark Lamet, MD
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Gastroenterology Consultants
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Northwest Gastroenterology
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Indianapolis Gastroenterology Research Foundation
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
St. Vincent Hospital: Research Department
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Drug Research Services, Inc.
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70001
Country
United States
Facility Name
Maryland Clinical Trials
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Chevy Chase Clinical Research
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Capital Gastroenterology Consultants, P.A.
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20901
Country
United States
Facility Name
Clinical Pharmacology Study Group
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01610
Country
United States
Facility Name
Mayo Clinic Research
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905-0002
Country
United States
Facility Name
Gastroenterology & Hematology
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Glenn Gordon, MD
City
Mexico
State/Province
Missouri
ZIP/Postal Code
65265
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University School
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Long Island Clinical Research Assoc.
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
NY Center for Clinical Research
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Daniel Present, MD
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Digestive Disease Associates of Rockland
City
Pomona
State/Province
New York
ZIP/Postal Code
10970
Country
United States
Facility Name
Charlotte Gastroenterology & Hepatology
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Carolina Digestive Health Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Carolina Research Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28262
Country
United States
Facility Name
Le Bauer Research, P.A.
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Wilmington Gastroenterology
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Westhills Gastroenterology
City
Portland
State/Province
Oregon
ZIP/Postal Code
98112
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Facility Name
Columbia Gastro Associates
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
Gastroenterology Center of the Mid South
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Nashville Medical Research
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Gastrointestinal Specialists
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
Discovery Research Inteternational, LLC
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Wisconsin Center for Advanced Research
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34546360
Citation
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.
Results Reference
derived
PubMed Identifier
29380251
Citation
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.
Results Reference
derived
PubMed Identifier
24134498
Citation
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.
Results Reference
derived
PubMed Identifier
22704916
Citation
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.
Results Reference
derived
PubMed Identifier
21645018
Citation
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.
Results Reference
derived
PubMed Identifier
19201775
Citation
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.
Results Reference
derived

Learn more about this trial

Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease

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