Remission in Subjects With Crohn's Disease, 1 Year Phase
NCT ID: NCT00055497
Last Updated: 2011-04-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
276 participants
INTERVENTIONAL
2002-08-31
2008-12-31
Brief Summary
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Detailed Description
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Potential participants were screened at the time of enrollment in the lead-in, induction therapy study (NCT00055523). Participants who completed the lead-in study, NCT00055523, were eligible to participate in the rollover study, NCT00055497.
In Study NCT00055497, all participants received 40 mg of adalimumab subcutaneously (SC) at Baseline (Week 0) and Week 2 of Study NCT00055497. Baseline of Study NCT00055497 is synonymous with NCT00055523 Week 4. At Week 4 of Study NCT00055497, participants were randomized based on their clinical remission status at Baseline and Week 4 of Study NCT00055497. Participants who demonstrated clinical remission (defined as a Crohn's Disease Activity Index \[CDAI\] score \< 150 points) at Baseline of Study NCT00055497 and who remained in clinical remission at Week 4 of Study NCT00055497 (those participants constituted the randomized analysis set) were randomized to receive 1 of 3 blinded treatments: adalimumab 40 mg every other week (eow), adalimumab 40 mg every week (ew), or placebo. Participants who did not demonstrate clinical remission at Baseline of Study NCT00055497, or who were no longer in clinical remission at Week 4 of Study NCT00055497 were assigned to receive OL adalimumab 40 mg eow; those participants constituted the OL analysis set. At any time during Study NCT00055497, participants receiving OL adalimumab 40 mg SC eow who developed a flare or were non-responders during OL treatment could have had his/her dose increased to 40 mg SC weekly. Participants who were documented as having completed Week 56 are counted in the study completion total.
After 1 year (Week 56), participants who met eligibility criteria for the long-term extension phase (NCT01070303) were switched to OL adalimumab 40 mg subcutaneous (SC) eow, and participants previously in the OL treatment group of Study NCT00055497 continued on their previous OL adalimumab dose (adalimumab 40 mg SC eow or every week).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Double-blind (DB) adalimumab placebo
Double-blind nonactive matching subcutaneous injection
Double-blind (DB) adalimumab placebo
Double-blind nonactive matching subcutaneous injection
Double-blind adalimumab 40 mg every other week (eow)
Double-blind adalimumab 40 mg eow by subcutaneous injection
DB adalimumab 40 mg eow
Double-blind adalimumab 40 mg every other week by subcutaneous injection
Double-blind adalimumab 40 mg every week (ew)
Double-blind adalimumab 40 mg every week by subcutaneous injection
DB adalimumab 40 mg ew
Double-blind adalimumab 40 mg every week by subcutaneous injection
Open-label adalimumab 40 mg
Open-label adalimumab 40 mg eow or ew by subcutaneous injection
OL adalimumab 40 mg
Open-label adalimumab every other week or every week by subcutaneous injection
Interventions
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Double-blind (DB) adalimumab placebo
Double-blind nonactive matching subcutaneous injection
DB adalimumab 40 mg eow
Double-blind adalimumab 40 mg every other week by subcutaneous injection
DB adalimumab 40 mg ew
Double-blind adalimumab 40 mg every week by subcutaneous injection
OL adalimumab 40 mg
Open-label adalimumab every other week or every week by subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Crohn's disease
* Willing and able to give informed consent
Exclusion:
* 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
18 Years
75 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Responsible Party
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Abbott
Principal Investigators
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Anne Camez, MD
Role: STUDY_DIRECTOR
Abbott
Locations
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Gastroenterology Associates of the East Bay
Berkeley, California, United States
Long Beach Gastroenterology Assoc.
Long Beach, California, United States
Sharp Rees-Stealy Medical Group
San Diego, California, United States
Gastroenterology Assoc. of Fairfield Co.
Bridgeport, Connecticut, United States
Cleveland Clinic Florida
Weston, Florida, United States
Wake Research Associates
Weston, Florida, United States
Shafran Gastroenterology Center
Winter Park, Florida, United States
Atlanta Gastroenterology Assoc.
Atlanta, Georgia, United States
Southeastern Digestive & Liver Disease
Savannah, Georgia, United States
Northwest Gastroenterologists, S.C.
Arlington Heights, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Drug Research Services, Inc.
Metairie, Louisiana, United States
LSU School of Medicine
New Orleans, Louisiana, United States
Digestive Disorders Associates
Annapolis, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Clinical Pharmacology Study Group
Worchester, Massachusetts, United States
Mayo Clinic and Mayo Foundation
Rochester, Minnesota, United States
Gastroenterology and Hepatology
Kansas City, Missouri, United States
Glenn Gordon, MD
Mexico, Missouri, United States
Deaconess Billings Clinic Research Division
Billings, Montana, United States
Gastroenterology Specialties, P.C.
Lincoln, Nebraska, United States
Long Island Clinical Research Associates
Great Neck, New York, United States
NY Center for Clinical Research
Lake Success, New York, United States
New York Presbyterian Hospital
New York, New York, United States
Daniel Present
New York, New York, United States
Rochester Institute for Digestive Diseases
Rochester, New York, United States
UNC School of Medicine
Chapel Hill, North Carolina, United States
Charlotte Gastroenterology and Hepatology
Charlotte, North Carolina, United States
Carolina Research Associates
Charlotte, North Carolina, United States
Digestive Health Specialists
Winston-Salem, North Carolina, United States
Consultants for Clinical Research
Cincinnati, Ohio, United States
Oklahoma Foundation for Digestive Disease
Oklahoma City, Oklahoma, United States
Research Solutions
Tulsa, Oklahoma, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Peter Molloy, MD
Pittsburgh, Pennsylvania, United States
Diseases of the Digestive System
Chattanooga, Tennessee, United States
Nashville Medical Research Institute
Nashville, Tennessee, United States
Charlottesville Medical Research
Charlottesville, Virginia, United States
Northwest Gastroenterology
Bellevue, Washington, United States
Inland Empire Gastroenterology
Spokane, Washington, United States
Tacoma Digestive Disease Center
Tacoma, Washington, United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States
Countries
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References
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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.
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.
Other Identifiers
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M02-433
Identifier Type: -
Identifier Source: org_study_id
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