Remission in Subjects With Crohn's Disease, 1 Year Phase
CLASSICII
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Maintenance of Clinical Remission in Subjects With Crohn's Disease
1 other identifier
interventional
276
1 country
43
Brief Summary
The objectives were: (1) To demonstrate the efficacy of adalimumab in the maintenance of clinical remission up to 56 weeks in participants with Crohn's disease who participated in NCT00055523; (2) To delineate the safety of adalimumab when administered to participants with Crohn's disease up to 56 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2002
Longer than P75 for phase_3
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2002
CompletedFirst Submitted
Initial submission to the registry
March 3, 2003
CompletedFirst Posted
Study publicly available on registry
March 5, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedResults Posted
Study results publicly available
May 18, 2010
CompletedApril 11, 2011
April 1, 2011
2.4 years
March 3, 2003
December 15, 2009
April 7, 2011
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Randomized Participants Achieving Clinical Remission at Week 56 - Non-Responder Imputation (NRI)
Clinical remission is defined as CDAI score \<150. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \>/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
Week 56
Number of Randomized Participants Achieving Clinical Remission at Week 56 - Last Observation Carried Forward (LOCF)
Clinical remission is defined as CDAI score \<150. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \>/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
Week 56
Secondary Outcomes (9)
Number of Participants Achieving Clinical Remission at Week 24 - NRI
Week 24
Number of OL Participants Achieving Clinical Remission at Week 56 - NRI
Week 56
Number of Participants Achieving Clinical Response 100 (CR-100) - NRI
From Baseline of lead-in study to Week 24 and Week 56
Number of Participants Achieving Clinical Response 70 (CR-70)- NRI
From Baseline of lead-in study to Week 24 and to Week 56
Number of Participants Achieving Clinical Remission at Week 24 - LOCF
Week 24
- +4 more secondary outcomes
Study Arms (4)
Double-blind (DB) adalimumab placebo
PLACEBO COMPARATORDouble-blind nonactive matching subcutaneous injection
Double-blind adalimumab 40 mg every other week (eow)
EXPERIMENTALDouble-blind adalimumab 40 mg eow by subcutaneous injection
Double-blind adalimumab 40 mg every week (ew)
EXPERIMENTALDouble-blind adalimumab 40 mg every week by subcutaneous injection
Open-label adalimumab 40 mg
EXPERIMENTALOpen-label adalimumab 40 mg eow or ew by subcutaneous injection
Interventions
Double-blind nonactive matching subcutaneous injection
Double-blind adalimumab 40 mg every other week by subcutaneous injection
Double-blind adalimumab 40 mg every week by subcutaneous injection
Open-label adalimumab every other week or every week by subcutaneous injection
Eligibility Criteria
You may qualify if:
- Patient must have successfully completed the induction study NCT00055523
- Diagnosis of Crohn's disease
- Willing and able to give informed consent
You may not qualify if:
- Diagnosis of ulcerative colitis
- Pregnancy or breastfeeding
- Previous use of infliximab or other anti-TNF antagonists
- Previous history of active tuberculosis or listeria infection
- Previous history of cancer other than successfully treated skin cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (43)
Gastroenterology Associates of the East Bay
Berkeley, California, 94705, United States
Long Beach Gastroenterology Assoc.
Long Beach, California, 90806, United States
Sharp Rees-Stealy Medical Group
San Diego, California, 92123, United States
Gastroenterology Assoc. of Fairfield Co.
Bridgeport, Connecticut, 06606, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Wake Research Associates
Weston, Florida, 33331, United States
Shafran Gastroenterology Center
Winter Park, Florida, 32789, United States
Atlanta Gastroenterology Assoc.
Atlanta, Georgia, 30342, United States
Southeastern Digestive & Liver Disease
Savannah, Georgia, 31404, United States
Northwest Gastroenterologists, S.C.
Arlington Heights, Illinois, 60005, United States
University of Chicago
Chicago, Illinois, 60637, United States
Drug Research Services, Inc.
Metairie, Louisiana, 70001, United States
LSU School of Medicine
New Orleans, Louisiana, 70115, United States
Digestive Disorders Associates
Annapolis, Maryland, 21401, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Clinical Pharmacology Study Group
Worchester, Massachusetts, 01610, United States
Mayo Clinic and Mayo Foundation
Rochester, Minnesota, 55905, United States
Gastroenterology and Hepatology
Kansas City, Missouri, 64131, United States
Glenn Gordon, MD
Mexico, Missouri, 65265, United States
Deaconess Billings Clinic Research Division
Billings, Montana, 59101, United States
Gastroenterology Specialties, P.C.
Lincoln, Nebraska, 68503, United States
Long Island Clinical Research Associates
Great Neck, New York, 11021, United States
NY Center for Clinical Research
Lake Success, New York, 11042, United States
New York Presbyterian Hospital
New York, New York, 10021, United States
Daniel Present
New York, New York, 10029, United States
Rochester Institute for Digestive Diseases
Rochester, New York, 14607, United States
UNC School of Medicine
Chapel Hill, North Carolina, 27599, United States
Charlotte Gastroenterology and Hepatology
Charlotte, North Carolina, 28207, United States
Carolina Research Associates
Charlotte, North Carolina, 28262, United States
Digestive Health Specialists
Winston-Salem, North Carolina, 27103, United States
Consultants for Clinical Research
Cincinnati, Ohio, 45219, United States
Oklahoma Foundation for Digestive Disease
Oklahoma City, Oklahoma, 73104, United States
Research Solutions
Tulsa, Oklahoma, 74104, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Peter Molloy, MD
Pittsburgh, Pennsylvania, 15224, United States
Diseases of the Digestive System
Chattanooga, Tennessee, 37421, United States
Nashville Medical Research Institute
Nashville, Tennessee, 37205, United States
Charlottesville Medical Research
Charlottesville, Virginia, 22902, United States
Northwest Gastroenterology
Bellevue, Washington, 98004, United States
Inland Empire Gastroenterology
Spokane, Washington, 99204, United States
Tacoma Digestive Disease Center
Tacoma, Washington, 98405, United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53207, United States
Related Publications (2)
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.
PMID: 29380251DERIVEDSteenholdt 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.
PMID: 22344964DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- Abbott
Study Officials
- STUDY DIRECTOR
Anne Camez, MD
Abbott
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 3, 2003
First Posted
March 5, 2003
Study Start
August 1, 2002
Primary Completion
January 1, 2005
Study Completion
December 1, 2008
Last Updated
April 11, 2011
Results First Posted
May 18, 2010
Record last verified: 2011-04