Clinical trial NCT00077779: Adalimumab for the Induction and Maintenance 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 and Maintenance of Clinical Remission in Subjects With Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn's Disease
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2004-02-16
Enrollment: 854
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


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.

Primary outcomes:
measure: Clinical remission (CDAI<150).
timeFrame: 56 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Thornton Hospital Reumatology Division
state: California
city: San Francisco
country: United States
facility: UCSF San Francisco General Hospital
state: California
city: San Francisco
country: United States
facility: Cal-West, Inc.
state: California
city: Arvada
country: United States
facility: Western States Clinical Research
state: Colorado
city: Bridgeport
country: United States
facility: Gastroenterology Associates of Fairfield County
state: Connecticut
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Gainsville
country: United States
facility: V.A. Medical Center
state: Florida
city: Hollywood
country: United States
facility: Mark Lamet, MD
state: Florida
city: Ormond Beach
country: United States
facility: Gastroenterology Consultants
state: Florida
city: Arlington Heights
country: United States
facility: Northwest Gastroenterology
state: Illinois
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indianapolis Gastroenterology Research Foundation
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent Hospital: Research Department
state: Indiana
city: Metairie
country: United States
facility: Drug Research Services, Inc.
state: Louisiana
city: Annapolis
country: United States
facility: Maryland Clinical Trials
state: Maryland
city: Chevy Chase
country: United States
facility: Chevy Chase Clinical Research
state: Maryland
city: Silver Spring
country: United States
facility: Capital Gastroenterology Consultants, P.A.
state: Maryland
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic Research
state: Minnesota
city: Kansas City
country: United States
facility: Gastroenterology & Hematology
state: Missouri
city: Mexico
country: United States
facility: Glenn Gordon, MD
state: Missouri
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: St. Louis
country: United States
facility: Washington University School
state: Missouri
city: Great Neck
country: United States
facility: Long Island Clinical Research Assoc.
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: Daniel Present, MD
state: New York
city: Pomona
country: United States
facility: Digestive Disease Associates of Rockland
state: New York
city: Charlotte
country: United States
facility: Charlotte Gastroenterology & Hepatology
state: North Carolina
city: Charlotte
country: United States
facility: Carolina Digestive Health Associates
state: North Carolina
city: Charlotte
country: United States
facility: Carolina Research Associates
state: North Carolina
city: Greensboro
country: United States
facility: Le Bauer Research, P.A.
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Gastroenterology
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Portland
country: United States
facility: Westhills Gastroenterology
state: Oregon
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Columbia
country: United States
facility: Columbia Gastro Associates
state: South Carolina
city: Memphis
country: United States
facility: Gastroenterology Center of the Mid South
state: Tennessee
city: Nashville
country: United States
facility: Nashville Medical Research
state: Tennessee
city: Richmond
country: United States
facility: Gastrointestinal Specialists
state: Virginia
city: Milwaukee
country: United States
facility: Discovery Research Inteternational, LLC
state: Wisconsin
city: Milwaukee
country: United States
facility: Wisconsin Center for Advanced Research
state: Wisconsin
Study officials:
affiliation: Abbott
name: Paul F Pollack, M.D.
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.