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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00055497
First received: March 3, 2003
Last updated: April 7, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Crohn's Disease
Biological: Double-blind (DB) adalimumab placebo
Biological: DB adalimumab 40 mg eow
Biological: DB adalimumab 40 mg ew
Biological: OL adalimumab 40 mg
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Number of Randomized Participants Achieving Clinical Remission at Week 56 - Non-Responder Imputation (NRI) [ Time Frame: Week 56 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Week 56 ] [ Designated as safety issue: No ]
    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:
  • Number of Participants Achieving Clinical Remission at Week 24 - NRI [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 56 ] [ Designated as safety issue: No ]
    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 [ Time Frame: From Baseline of lead-in study to Week 24 and Week 56 ] [ Designated as safety issue: No ]
    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 [ Time Frame: From Baseline of lead-in study to Week 24 and to Week 56 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 56 ] [ Designated as safety issue: No ]
    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 [ Time Frame: From Baseline of lead-in study to Week 24 and Week 56 ] [ Designated as safety issue: No ]
    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 [ Time Frame: From Baseline of lead-in study to Week 24 and Week 56 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from Baseline of lead-in study to Week 24 and Week 56 ] [ Designated as safety issue: No ]
    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.


Enrollment: 276
Study Start Date: August 2002
Study Completion Date: December 2008
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Double-blind (DB) adalimumab placebo
Double-blind nonactive matching subcutaneous injection
Biological: Double-blind (DB) adalimumab placebo
Double-blind nonactive matching subcutaneous injection
Other Name: Humira®
Experimental: Double-blind adalimumab 40 mg every other week (eow)
Double-blind adalimumab 40 mg eow by subcutaneous injection
Biological: DB adalimumab 40 mg eow
Double-blind adalimumab 40 mg every other week by subcutaneous injection
Other Name: Humira®
Experimental: Double-blind adalimumab 40 mg every week (ew)
Double-blind adalimumab 40 mg every week by subcutaneous injection
Biological: DB adalimumab 40 mg ew
Double-blind adalimumab 40 mg every week by subcutaneous injection
Other Name: Humira®
Experimental: Open-label adalimumab 40 mg
Open-label adalimumab 40 mg eow or ew by subcutaneous injection
Biological: OL adalimumab 40 mg
Open-label adalimumab every other week or every week by subcutaneous injection
Other Name: Humira®

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00055497

  Hide Study Locations
Locations
United States, California
Gastroenterology Associates of the East Bay
Berkeley, California, United States, 94705
Long Beach Gastroenterology Assoc.
Long Beach, California, United States, 90806
Sharp Rees-Stealy Medical Group
San Diego, California, United States, 92123
United States, Connecticut
Gastroenterology Assoc. of Fairfield Co.
Bridgeport, Connecticut, United States, 06606
United States, Florida
Wake Research Associates
Weston, Florida, United States, 33331
Cleveland Clinic Florida
Weston, Florida, United States, 33331
Shafran Gastroenterology Center
Winter Park, Florida, United States, 32789
United States, Georgia
Atlanta Gastroenterology Assoc.
Atlanta, Georgia, United States, 30342
Southeastern Digestive & Liver Disease
Savannah, Georgia, United States, 31404
United States, Illinois
Northwest Gastroenterologists, S.C.
Arlington Heights, Illinois, United States, 60005
University of Chicago
Chicago, Illinois, United States, 60637
United States, Louisiana
Drug Research Services, Inc.
Metairie, Louisiana, United States, 70001
LSU School of Medicine
New Orleans, Louisiana, United States, 70115
United States, Maryland
Digestive Disorders Associates
Annapolis, Maryland, United States, 21401
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Clinical Pharmacology Study Group
Worchester, Massachusetts, United States, 01610
United States, Minnesota
Mayo Clinic and Mayo Foundation
Rochester, Minnesota, United States, 55905
United States, Missouri
Gastroenterology and Hepatology
Kansas City, Missouri, United States, 64131
Glenn Gordon, MD
Mexico, Missouri, United States, 65265
United States, Montana
Deaconess Billings Clinic Research Division
Billings, Montana, United States, 59101
United States, Nebraska
Gastroenterology Specialties, P.C.
Lincoln, Nebraska, United States, 68503
United States, New York
Long Island Clinical Research Associates
Great Neck, New York, United States, 11021
NY Center for Clinical Research
Lake Success, New York, United States, 11042
Daniel Present
New York, New York, United States, 10029
New York Presbyterian Hospital
New York, New York, United States, 10021
Rochester Institute for Digestive Diseases
Rochester, New York, United States, 14607
United States, North Carolina
UNC School of Medicine
Chapel Hill, North Carolina, United States, 27599
Charlotte Gastroenterology and Hepatology
Charlotte, North Carolina, United States, 28207
Carolina Research Associates
Charlotte, North Carolina, United States, 28262
Digestive Health Specialists
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Consultants for Clinical Research
Cincinnati, Ohio, United States, 45219
United States, Oklahoma
Oklahoma Foundation for Digestive Disease
Oklahoma City, Oklahoma, United States, 73104
Research Solutions
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Peter Molloy, MD
Pittsburgh, Pennsylvania, United States, 15224
United States, Tennessee
Diseases of the Digestive System
Chattanooga, Tennessee, United States, 37421
Nashville Medical Research Institute
Nashville, Tennessee, United States, 37205
United States, Virginia
Charlottesville Medical Research
Charlottesville, Virginia, United States, 22902
United States, Washington
Northwest Gastroenterology
Bellevue, Washington, United States, 98004
Inland Empire Gastroenterology
Spokane, Washington, United States, 99204
Tacoma Digestive Disease Center
Tacoma, Washington, United States, 98405
United States, Wisconsin
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States, 53207
Sponsors and Collaborators
Abbott
Investigators
Study Director: Anne Camez, MD Abbott
  More Information

No publications provided by Abbott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anne Camez, Medical Director, Abbott
ClinicalTrials.gov Identifier: NCT00055497     History of Changes
Other Study ID Numbers: M02-433
Study First Received: March 3, 2003
Results First Received: December 15, 2009
Last Updated: April 7, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Antibodies, Monoclonal
Adalimumab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 28, 2014