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

  Show 43 Study Locations
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
Antirheumatic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 21, 2014