Clinical trial NCT00055523: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn's Disease
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2003-03-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)


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

Primary outcomes:
measure: comparison of the induction of clinical remission
measure: (achievement of a CDAI <150) of adalimumab 40 mg and 80 mg vs. placebo at Week 4.
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Gastroenterology Associates of the East Bay
state: California
city: Long Beach
country: United States
facility: Long Beach Gastroenterology Assoc.
state: California
city: San Diego
country: United States
facility: Sharp Rees-Stealy Medical Group
state: California
city: Bridgeport
country: United States
facility: Gastroenterology Assoc. of Fairfield Co.
state: Connecticut
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Winter Park
country: United States
facility: Shafran Gastroenterology Center
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Assoc.
state: Georgia
city: Savannah
country: United States
facility: Southeastern Digestive & Liver Disease
state: Georgia
city: Arlington Heights
country: United States
facility: Northwest Gastroenterologists, S.C.
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Metairie
country: United States
facility: Drug Research Services, Inc.
state: Louisiana
city: New Orleans
country: United States
facility: LSU School of Medicine
state: Louisiana
city: Annapolis
country: United States
facility: Digestive Disorders Associates
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic and Mayo Foundation
state: Minnesota
city: Kansas City
country: United States
facility: Gastroenterology and Hepatology
state: Missouri
city: Mexico
country: United States
facility: Glenn Gordon, MD
state: Missouri
city: Billings
country: United States
facility: Deaconess Billings Clinic Research Division
state: Montana
city: Lincoln
country: United States
facility: Gastroenterology Specialties, P.C.
state: Nebraska
city: Great Neck
country: United States
facility: Long Island Clinical Research Associates
state: New York
city: Lake Success
country: United States
facility: NY Center for Clinical Research
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Daniel Present
state: New York
city: Rochester
country: United States
facility: Rochester Institute for Digestive Diseases
state: New York
city: Chapel Hill
country: United States
facility: UNC School of Medicine
state: North Carolina
city: Charlotte
country: United States
facility: Charlotte Gastroenterology and Hepatology
state: North Carolina
city: Charlotte
country: United States
facility: Carolina Research Associates
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Digestive Health Specialists
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants for Clinical Research
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Foundation for Digestive Disease
state: Oklahoma
city: Tulsa
country: United States
facility: Research Solutions
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Peter Molloy, MD
state: Pennsylvania
city: Chattanooga
country: United States
facility: Diseases of the Digestive System
state: Tennessee
city: Nashville
country: United States
facility: Nashville Medical Research Institute
state: Tennessee
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
city: Bellevue
country: United States
facility: Northwest Gastroenterology
state: Washington
city: Spokane
country: United States
facility: Inland Empire Gastroenterology
state: Washington
city: Tacoma
country: United States
facility: Tacoma Digestive Disease Center
state: Washington
city: Milwaukee
country: United States
facility: Wisconsin Center for Advanced Research
state: Wisconsin
Study officials:
affiliation: University of Chicago Department of Medicine
name: Stephen B Hanauer, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.