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Remission in Subjects With Crohn's Disease, Open Label Extension

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: Adalimumab 40 mg eow or ew (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 long-term maintenance of clinical remission in participants with Crohn's disease; and (2) To delineate the long-term safety of adalimumab when administered to participants with Crohn's disease.

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, Open Label Extension

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Participants Achieving Clinical Remission (Crohn's Disease Activity Index[CDAI] <150 Points) at Week 104 of Study M02-433 (Starting From Week 0 of NCT00055497) (Through 1 Year of Participation in NCT01070303).

Secondary outcome:

Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 152 (Through 2 Years of Participation in NCT01070303).

Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 212 (Through 3 Years of Participation in NCT01070303).

Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 260 (4 Years of Participation in NCT01070303).

Number of Participants Achieving CR-100 at Week 104 (1 Year of Participation in NCT01070303)

Number of Participants Achieving CR-100 at Week 152 (2 Years of Participation in NCT01070303)

Number of Participants Achieving CR-100 at Week 212 (3 Years of Participation in NCT01070303)

Number of Participants Achieving CR-100 at Week 260 (4 Years of Participation in NCT01070303)

Number of Participants Achieving CR-70 at Week 104 (1 Year of Participation in NCT01070303)

Number of Participants Achieving CR-70 at Week 152 (2 Years of Participation in NCT01070303)

Number of Participants Achieving CR-70 at Week 212 (3 Years of Participation in NCT01070303)

Number of Participants Achieving CR-70 at Week 260 (4 Years of Participation in NCT01070303)

Number of Participants Achieving Steroid-free Clinical Remission at Week 104 (1 Year of Participation in NCT01070303)

Number of Achieving Steroid-free Clinical Remission at Week 152 (2 Years of Participation in NCT01070303)

Number of Participants Achieving Steroid-free Clinical Remission at Week 212 (3 Years of Participation in NCT01070303)

Number of Participants Achieving Steroid-free Clinical Remission at Week 260 (4 Years of Participation in NCT01070303)

Number of Participants Achieving Steroid-free CR-100 at Week 104 (1 Year of Participation in NCT01070303)

Number of Participants Achieving Steroid-free CR-100 at Week 152 (2 Years of Participation in NCT01070303)

Number of Participants Achieving Steroid-free CR-100 at Week 212 (3 Years of Participation in NCT01070303)

Number of Participants Achieving Steroid-free CR-100 at Week 260 (4 Years of Participation in NCT01070303)

Changes in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores

Number of Participants Achieving Fistula Remission at Week 104 (1 Year of Participation in NCT01070303)

Number of Participants Achieving Fistula Remission at Week 152 (2 Years of Participation in NCT01070303)

Number of Participants Achieving Fistula Remission at Week 212 (3 Years of Participation in NCT01070303)

Number of Participants Achieving Fistula Remission at Week 260 (Years of Participation in NCT01070303)

Detailed description: Study M02-433 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. a 1-year phase (Week 0 to Week 56) (NCT00055497) that consisted of a randomized, double-blind, placebo-controlled portion with a concomitant open label (OL) portion, and 2. a long-term open-label extension (OLE) phase (NCT01070303) that lasted 264 additional weeks (Week 56 to Week 320). 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).

Eligibility

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

Criteria:

Inclusion Criteria:

- Participant had completed the Year 1 of Study M02-433 (NCT00055497)

- Diagnosis of Crohn's disease

- Willing and able to give informed consent

Exclusion Criteria:

- Diagnosis of ulcerative colitis

- 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

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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