Remission in Subjects With Crohn's Disease, 1 Year Phase
- Conditions
- Crohn's Disease
- Interventions
- Biological: Double-blind (DB) adalimumab placeboBiological: DB adalimumab 40 mg eowBiological: DB adalimumab 40 mg ewBiological: OL adalimumab 40 mg
- Registration Number
- NCT00055497
- Lead Sponsor
- Abbott
- 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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 276
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Double-blind (DB) adalimumab placebo Double-blind (DB) adalimumab placebo Double-blind nonactive matching subcutaneous injection Double-blind adalimumab 40 mg every other week (eow) DB adalimumab 40 mg eow Double-blind adalimumab 40 mg eow by subcutaneous injection Double-blind adalimumab 40 mg every week (ew) DB adalimumab 40 mg ew Double-blind adalimumab 40 mg every week by subcutaneous injection Open-label adalimumab 40 mg OL adalimumab 40 mg Open-label adalimumab 40 mg eow or ew by subcutaneous injection
- Primary Outcome Measures
Name Time Method Number of Randomized Participants Achieving Clinical Remission at Week 56 - Non-Responder Imputation (NRI) Week 56 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.
Number of Randomized Participants Achieving Clinical Remission at Week 56 - Last Observation Carried Forward (LOCF) Week 56 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.
- Secondary Outcome Measures
Name Time Method Number of Participants Achieving Clinical Remission at Week 24 - NRI Week 24 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.
Number of OL Participants Achieving Clinical Remission at Week 56 - NRI Week 56 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.
Number of Participants Achieving Clinical Response 100 (CR-100) - NRI From Baseline of lead-in study to Week 24 and Week 56 A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating significant improvement in disease severity. 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.
Number of Participants Achieving Clinical Response 70 (CR-70)- NRI From Baseline of lead-in study to Week 24 and to Week 56 A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. 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.
Number of Participants Achieving Clinical Remission at Week 24 - LOCF Week 24 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.
Number of OL Participants Achieving Clinical Remission at Week 56 - LOCF Week 56 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.
Number of Participants Achieving CR-100 - LOCF From Baseline of lead-in study to Week 24 and Week 56 A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating significant improvement in disease severity. 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.
Number of Participants Achieving CR-70 - LOCF From Baseline of lead-in study to Week 24 and Week 56 A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. 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.
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores - LOCF Change from Baseline of lead-in study to Week 24 and Week 56 IBDQ is a validated disease-specific instrument that assesses the impact of IBD on patient quality of life during a 2-week recall period. It has 32 questions about bowel function and related symptoms, and their social and emotional impact. For each question, participants selected 1 of 7 responses, where 1=poor quality of life (e.g., feeling of fatigue "all of the time") and 7=good quality on the item (e.g., feeling of fatigue "none of the time"). IBDQ scores range from 32 to 224. Higher scores indicate better quality of life, and increases in IBDQ indicate improved overall quality of life.
Trial Locations
- Locations (43)
Northwest Gastroenterologists, S.C.
🇺🇸Arlington Heights, Illinois, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Wake Research Associates
🇺🇸Weston, Florida, United States
Cleveland Clinic Florida
🇺🇸Weston, Florida, 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
Gastroenterology Specialties, P.C.
🇺🇸Lincoln, Nebraska, United States
Deaconess Billings Clinic Research Division
🇺🇸Billings, Montana, United States
New York Presbyterian Hospital
🇺🇸New York, New York, United States
Wisconsin Center for Advanced Research
🇺🇸Milwaukee, Wisconsin, United States
Oklahoma Foundation for Digestive Disease
🇺🇸Oklahoma City, Oklahoma, United States
Nashville Medical Research Institute
🇺🇸Nashville, Tennessee, United States
Gastroenterology and Hepatology
🇺🇸Kansas City, Missouri, United States
Long Beach Gastroenterology Assoc.
🇺🇸Long Beach, California, United States
Shafran Gastroenterology Center
🇺🇸Winter Park, Florida, United States
Sharp Rees-Stealy Medical Group
🇺🇸San Diego, California, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Atlanta Gastroenterology Assoc.
🇺🇸Atlanta, Georgia, United States
Consultants for Clinical Research
🇺🇸Cincinnati, Ohio, United States
Mayo Clinic and Mayo Foundation
🇺🇸Rochester, Minnesota, United States
NY Center for Clinical Research
🇺🇸Lake Success, New York, United States
Carolina Research Associates
🇺🇸Charlotte, North Carolina, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Peter Molloy, MD
🇺🇸Pittsburgh, Pennsylvania, United States
Charlotte Gastroenterology and Hepatology
🇺🇸Charlotte, North Carolina, United States
Digestive Health Specialists
🇺🇸Winston-Salem, North Carolina, United States
Daniel Present
🇺🇸New York, New York, United States
Rochester Institute for Digestive Diseases
🇺🇸Rochester, New York, United States
Inland Empire Gastroenterology
🇺🇸Spokane, Washington, United States
Tacoma Digestive Disease Center
🇺🇸Tacoma, Washington, United States
Southeastern Digestive & Liver Disease
🇺🇸Savannah, Georgia, United States
Gastroenterology Associates of the East Bay
🇺🇸Berkeley, California, United States
Gastroenterology Assoc. of Fairfield Co.
🇺🇸Bridgeport, Connecticut, United States
Drug Research Services, Inc.
🇺🇸Metairie, Louisiana, United States
Clinical Pharmacology Study Group
🇺🇸Worchester, Massachusetts, United States
UNC School of Medicine
🇺🇸Chapel Hill, North Carolina, United States
Long Island Clinical Research Associates
🇺🇸Great Neck, New York, United States
Diseases of the Digestive System
🇺🇸Chattanooga, Tennessee, United States
Research Solutions
🇺🇸Tulsa, Oklahoma, United States
Northwest Gastroenterology
🇺🇸Bellevue, Washington, United States
Glenn Gordon, MD
🇺🇸Mexico, Missouri, United States
Charlottesville Medical Research
🇺🇸Charlottesville, Virginia, United States