Remission in Subjects With Crohn's Disease, Open Label Extension
NCT ID: NCT01070303
Last Updated: 2011-04-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
177 participants
INTERVENTIONAL
2002-08-31
2008-12-31
Brief Summary
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Detailed Description
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Participants who completed the lead-in study NCT00055523, were eligible to participate in the rollover study, NCT00055497. 176 participants were documented as having completed Year 1 (NCT00055497); however, 177 participants were still receiving study drug and were evaluated at Week 56 of NCT00055497; these participants are included in the OLE data (NCT01070303).
At Week 4 of NCT00055497, participants who demonstrated clinical remission (defined as a Crohn's Disease Activity Index \[CDAI\] score \<150 points) at Baseline of NCT00055497 and who remained in clinical remission at Week 4 ("Remitters") were randomized to receive 1 of 3 blinded treatments: placebo, adalimumab 40 mg every other week (eow), or adalimumab 40 mg every week (ew). Participants who did not demonstrate clinical remission at Baseline of NCT00055497 or who were no longer in clinical remission at Week 4 of NCT00055497 ("Non-remitters") were assigned to receive OL adalimumab 40 mg eow. All study drug (placebo and active) was administered by subcutaneous (SC) injection.
At any time during Study NCT00055497, a participant receiving blinded study drug who developed a disease flare could be switched to OL adalimumab 40 mg eow. A participant receiving OL adalimumab 40 mg SC eow who developed a flare or was a non-responders could have had his/her dose increased to 40 mg SC ew.
After 1 year (Week 56 of NCT00055497), patients who were still participating could continue in the OLE phase (NCT01070303). Participants who were receiving blinded study drug were switched to OL adalimumab 40 mg SC eow, and participants who were receiving OL study drug continued on their previous OL adalimumab dose (adalimumab 40 mg SC eow or ew).
Data are summarized for Remitters and Non-remitters, with the exception of data for primary reason for noncompletion. Summaries of primary reason for noncompletion were available only for all participants, not for Remitters and Non-remitters. Data are reported for Weeks 104, 152, 212, and 260 of Study M02-433, starting from Week 0 of NCT00055497; these weeks correspond to 1, 2, 3, and 4 years of participation in NCT01070303. Change from Baseline results (clinical response 70, clinical response 100, Inflammatory Bowel Disease Questionnaire, and fistula remission) are calculated from Baseline of the lead-in study (NCT00055523). Results on each assessment at each measurement time point are presented as individual outcome measures because different numbers of participants were evaluated at each time point (as observed analysis).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Adalimumab 40 mg every other week or every week
Adalimumab 40 mg eow or ew
Adalimumab 40 mg by subcutaneous injection every other week or every week
Interventions
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Adalimumab 40 mg eow or ew
Adalimumab 40 mg by subcutaneous injection every other week or every week
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 Criteria
* Pregnancy or breastfeeding
* Previous use of infliximab or other anti-TNF (tumor necrosing factor) 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.
Other Identifiers
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M02-433 Open Label
Identifier Type: -
Identifier Source: org_study_id
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