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Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 3
Locations
International
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 Criteria: 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 Exclusion Criteria: 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) 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

Sites / Locations

  • Clinical Research Associates
  • Capitol Gastroenterology Consultants Medical Group, Inc.
  • Medical Associates Research Group
  • Sharp Rees-Stealy Medical Group
  • SMC-Trauma Research
  • Clinical Research of West Florida, Inc
  • V.A. Medical Center
  • Borland-Groover Clinic
  • Shafran Gastroenterology Center
  • Pinnacle Trials, Inc.
  • Atlanta Gastroenterology Assoc.
  • The University of Chicago
  • Ntouch Research
  • Outpatient Clinical Research Facility University of Indianapolis
  • University of Kentucky Medical Center Division of Digestive Diseases
  • Drug Research Services, Inc.
  • Chevy Chase Clinical Research
  • Charm City Research
  • Minnesota Gastroenterology P.A.
  • Mayo Clinic Research
  • Gastrointestinal Associated, P.A.
  • Glen Gordon, MD
  • St. Louis Center for Clinical Research
  • Atlantic Gastroenterology Associates, LLC
  • Long Island Clinical Research Assoc. LLP
  • NY Center for Clinical Research
  • Mount Sinai School of Medicine IBD Research Center
  • Asheville Gastroenterology Associates
  • Wake Research Associates
  • Consultants for Clinical Research
  • Cleveland Clinic Foundation
  • Gastrointestinal and Liver Disease Consultants
  • Gastroenterology Associates of Cleveland
  • The Oregon Clinic, PC Gastroenterology Division
  • Regional Gastroenterologist Associates of Lancaster
  • University of Pittsburgh Medical Center
  • Columbia Gastro Associates
  • Gastrointestinal Associates
  • Gastroenterology Center of the Mid South
  • Vanderbilt University Medical Center
  • Austin Gastroenterology
  • Wasatch Clinical Research
  • Internal Medicine Associates
  • Digestive and Liver Disease
  • Spokane Digestive Disease Center
  • Discovery Research International, LLC
  • Imelda Ziekenhuis
  • UZ Gasthuisberg
  • Heritage Medical Research Clinic Health Sciences Centre University of Calgary
  • Liver and Intestinal Disease Research Center
  • St. Paul's Hospital
  • Winnipeg Health Sciences Centre
  • Queen Elizabeth II Health Sciences Centre
  • Toronto Digestive Disease Assoc. Inc
  • Royal Victoria Hospital
  • Hopital Claude Claude Huriez Hospital

Outcomes

Primary Outcome Measures

Induction of clinical remission (CDAI score < 150 at Week 4)

Secondary Outcome Measures

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

Full Information

First Posted
March 11, 2005
Last Updated
August 13, 2006
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00105300
Brief Title
Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
October 2004 (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 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.

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
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Adalimumab
Primary Outcome Measure Information:
Title
Induction of clinical remission (CDAI score < 150 at Week 4)
Secondary Outcome Measure Information:
Title
Clinical response measured as
Title
Decrease in Baseline CDAI score >= 70 points at Week 4
Title
Decrease in Baseline CDAI score >= 100 points at Week 4
Title
Changes in IBDQ scores at Week 4

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 Criteria: 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 Exclusion Criteria: 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) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Medical Information 1-800-633-9110
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Research Associates
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Capitol Gastroenterology Consultants Medical Group, Inc.
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Medical Associates Research Group
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Sharp Rees-Stealy Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
SMC-Trauma Research
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
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
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Borland-Groover Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Shafran Gastroenterology Center
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Pinnacle Trials, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Atlanta Gastroenterology Assoc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60673
Country
United States
Facility Name
Ntouch Research
City
Peoria
State/Province
Illinois
ZIP/Postal Code
60602
Country
United States
Facility Name
Outpatient Clinical Research Facility University of Indianapolis
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
462025250
Country
United States
Facility Name
University of Kentucky Medical Center Division of Digestive Diseases
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Drug Research Services, Inc.
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70001
Country
United States
Facility Name
Chevy Chase Clinical Research
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Charm City Research
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Minnesota Gastroenterology P.A.
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55446
Country
United States
Facility Name
Mayo Clinic Research
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
559050002
Country
United States
Facility Name
Gastrointestinal Associated, P.A.
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Glen Gordon, MD
City
Mexico
State/Province
Missouri
ZIP/Postal Code
65265
Country
United States
Facility Name
St. Louis Center for Clinical Research
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Atlantic Gastroenterology Associates, LLC
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
Country
United States
Facility Name
Long Island Clinical Research Assoc. LLP
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
Mount Sinai School of Medicine IBD Research Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Asheville Gastroenterology Associates
City
Ashville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Consultants for Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Gastrointestinal and Liver Disease Consultants
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45440
Country
United States
Facility Name
Gastroenterology Associates of Cleveland
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
The Oregon Clinic, PC Gastroenterology Division
City
Portland
State/Province
Oregon
ZIP/Postal Code
97220
Country
United States
Facility Name
Regional Gastroenterologist Associates of Lancaster
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
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
Gastrointestinal Associates
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
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
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Austin Gastroenterology
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Wasatch Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Internal Medicine Associates
City
Danville
State/Province
Virginia
ZIP/Postal Code
25451
Country
United States
Facility Name
Digestive and Liver Disease
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23205
Country
United States
Facility Name
Spokane Digestive Disease Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Discovery Research International, LLC
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53207
Country
United States
Facility Name
Imelda Ziekenhuis
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
UZ Gasthuisberg
City
Leuven
Country
Belgium
Facility Name
Heritage Medical Research Clinic Health Sciences Centre University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Facility Name
Liver and Intestinal Disease Research Center
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1H2
Country
Canada
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
Winnipeg Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Toronto Digestive Disease Assoc. Inc
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3N 2V7
Country
Canada
Facility Name
Royal Victoria Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
Hopital Claude Claude Huriez Hospital
City
Lille
State/Province
Cedex
ZIP/Postal Code
59037
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
17470824
Citation
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.
Results Reference
derived

Learn more about this trial

Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease

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