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

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Adalimumab (D2E7)
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: Diagnosis of Crohn's disease CDAI score at baseline of between 220 and 450 Normal laboratory parameters Willing and able to give informed consent Exclusion: 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

Sites / Locations

  • Gastroenterology Associates of the East Bay
  • Long Beach Gastroenterology Assoc.
  • Sharp Rees-Stealy Medical Group
  • Gastroenterology Assoc. of Fairfield Co.
  • Cleveland Clinic Florida
  • Shafran Gastroenterology Center
  • Atlanta Gastroenterology Assoc.
  • Southeastern Digestive & Liver Disease
  • Northwest Gastroenterologists, S.C.
  • University of Chicago
  • Drug Research Services, Inc.
  • LSU School of Medicine
  • Digestive Disorders Associates
  • Brigham and Women's Hospital
  • Massachusetts General Hospital
  • Clinical Pharmacology Study Group
  • Mayo Clinic and Mayo Foundation
  • Gastroenterology and Hepatology
  • Glenn Gordon, MD
  • Deaconess Billings Clinic Research Division
  • Gastroenterology Specialties, P.C.
  • Long Island Clinical Research Associates
  • NY Center for Clinical Research
  • New York Presbyterian Hospital
  • Daniel Present
  • Rochester Institute for Digestive Diseases
  • UNC School of Medicine
  • Charlotte Gastroenterology and Hepatology
  • Carolina Research Associates
  • Wake Research Associates
  • Digestive Health Specialists
  • Consultants for Clinical Research
  • Oklahoma Foundation for Digestive Disease
  • Research Solutions
  • Altoona Center for Clinical Research
  • Peter Molloy, MD
  • Diseases of the Digestive System
  • Nashville Medical Research Institute
  • Charlottesville Medical Research
  • Northwest Gastroenterology
  • Inland Empire Gastroenterology
  • Tacoma Digestive Disease Center
  • Wisconsin Center for Advanced Research

Outcomes

Primary Outcome Measures

comparison of the induction of clinical remission
(achievement of a CDAI <150) of adalimumab 40 mg and 80 mg vs. placebo at Week 4.

Secondary Outcome Measures

Full Information

First Posted
March 4, 2003
Last Updated
August 11, 2006
Sponsor
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00055523
Brief Title
A Study of the Human Anti-TNF Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
April 2002 (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
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)

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 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Adalimumab (D2E7)
Primary Outcome Measure Information:
Title
comparison of the induction of clinical remission
Title
(achievement of a CDAI <150) of adalimumab 40 mg and 80 mg vs. placebo 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: Diagnosis of Crohn's disease CDAI score at baseline of between 220 and 450 Normal laboratory parameters Willing and able to give informed consent Exclusion: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen B Hanauer, MD
Organizational Affiliation
University of Chicago Department of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gastroenterology Associates of the East Bay
City
Berkeley
State/Province
California
ZIP/Postal Code
94705
Country
United States
Facility Name
Long Beach Gastroenterology Assoc.
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
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
Gastroenterology Assoc. of Fairfield Co.
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Shafran Gastroenterology Center
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Atlanta Gastroenterology Assoc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Southeastern Digestive & Liver Disease
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31404
Country
United States
Facility Name
Northwest Gastroenterologists, S.C.
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
600005
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Drug Research Services, Inc.
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70001
Country
United States
Facility Name
LSU School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Digestive Disorders Associates
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
002115
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
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 and Mayo Foundation
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Gastroenterology and Hepatology
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
Deaconess Billings Clinic Research Division
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Gastroenterology Specialties, P.C.
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68503
Country
United States
Facility Name
Long Island Clinical Research Associates
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
New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Daniel Present
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Rochester Institute for Digestive Diseases
City
Rochester
State/Province
New York
ZIP/Postal Code
14607
Country
United States
Facility Name
UNC School of Medicine
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Charlotte Gastroenterology and Hepatology
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Carolina Research Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28262
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Digestive Health Specialists
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Consultants for Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Oklahoma Foundation for Digestive Disease
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Research Solutions
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Peter Molloy, MD
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Diseases of the Digestive System
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Nashville Medical Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Charlottesville Medical Research
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States
Facility Name
Northwest Gastroenterology
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Inland Empire Gastroenterology
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Tacoma Digestive Disease Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Wisconsin Center for Advanced Research
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53702
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22344964
Citation
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.
Results Reference
derived

Learn more about this trial

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

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