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Remission in Subjects With Crohn's Disease, 1 Year Phase

Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Crohn's Disease

Intervention: Double-blind (DB) adalimumab placebo (Biological); DB adalimumab 40 mg eow (Biological); DB adalimumab 40 mg ew (Biological); OL adalimumab 40 mg (Biological)

Phase: Phase 3

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Anne Camez, MD, Study Director, Affiliation: Abbott

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Number of Randomized Participants Achieving Clinical Remission at Week 56 - Non-Responder Imputation (NRI)

Number of Randomized Participants Achieving Clinical Remission at Week 56 - Last Observation Carried Forward (LOCF)

Secondary outcome:

Number of Participants Achieving Clinical Remission at Week 24 - NRI

Number of OL Participants Achieving Clinical Remission at Week 56 - NRI

Number of Participants Achieving Clinical Response 100 (CR-100) - NRI

Number of Participants Achieving Clinical Response 70 (CR-70)- NRI

Number of Participants Achieving Clinical Remission at Week 24 - LOCF

Number of OL Participants Achieving Clinical Remission at Week 56 - LOCF

Number of Participants Achieving CR-100 - LOCF

Number of Participants Achieving CR-70 - LOCF

Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores - LOCF

Detailed description: Study NCT00055497 was designed to evaluate the efficacy and safety of adalimumab in the maintenance of clinical remission in patients with Crohn's disease (CD). The study consisted of 2 phases: 1. the first year phase lasting until Week 56 and consisting of a randomized, double-blind (DB), placebo-controlled portion (NCT00055497) and of a concomitant open label (OL) portion, and 2. a long-term extension phase (NCT01070303) that lasted 264 additional weeks (Week 56 to Week 320). 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).

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion:

- Patient must have successfully completed the induction study NCT00055523

- 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

Locations and Contacts

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

Brigham and Women's Hospital, Boston, Massachusetts 02115, United States

Massachusetts General Hospital, Boston, Massachusetts 02114, 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

Daniel Present, New York, New York 10029, United States

New York Presbyterian Hospital, New York, New York 10021, United States

Rochester Institute for Digestive Diseases, Rochester, New York 14607, United States

UNC School of Medicine, Chapel Hill, North Carolina 27599, United States

Carolina Research Associates, Charlotte, North Carolina 28262, United States

Charlotte Gastroenterology and Hepatology, Charlotte, North Carolina 28207, 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

Additional Information

Starting date: August 2002
Last updated: April 7, 2011

Page last updated: August 23, 2015

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