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

Crohn's Disease Clinical Trial

— CLASSICII  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00055497
• Other study ID #: M02-433
• Status: Completed
• Phase: Phase 3
• First received: March 3, 2003
• Last updated: April 7, 2011
• Start date: August 2002
• Est. completion date: December 2008

Study information

• Verified date: April 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: December 2008
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Biological:
• Double-blind (DB) adalimumab placebo
Double-blind nonactive matching subcutaneous injection
• DB adalimumab 40 mg eow
Double-blind adalimumab 40 mg every other week by subcutaneous injection
• DB adalimumab 40 mg ew
Double-blind adalimumab 40 mg every week by subcutaneous injection
• OL adalimumab 40 mg
Open-label adalimumab every other week or every week by subcutaneous injection

Locations

Country	Name	City	State
United States	Digestive Disorders Associates	Annapolis	Maryland
United States	Northwest Gastroenterologists, S.C.	Arlington Heights	Illinois
United States	Atlanta Gastroenterology Assoc.	Atlanta	Georgia
United States	Northwest Gastroenterology	Bellevue	Washington
United States	Gastroenterology Associates of the East Bay	Berkeley	California
United States	Deaconess Billings Clinic Research Division	Billings	Montana
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Gastroenterology Assoc. of Fairfield Co.	Bridgeport	Connecticut
United States	UNC School of Medicine	Chapel Hill	North Carolina
United States	Carolina Research Associates	Charlotte	North Carolina
United States	Charlotte Gastroenterology and Hepatology	Charlotte	North Carolina
United States	Charlottesville Medical Research	Charlottesville	Virginia
United States	Diseases of the Digestive System	Chattanooga	Tennessee
United States	University of Chicago	Chicago	Illinois
United States	Consultants for Clinical Research	Cincinnati	Ohio
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Long Island Clinical Research Associates	Great Neck	New York
United States	Gastroenterology and Hepatology	Kansas City	Missouri
United States	NY Center for Clinical Research	Lake Success	New York
United States	Gastroenterology Specialties, P.C.	Lincoln	Nebraska
United States	Long Beach Gastroenterology Assoc.	Long Beach	California
United States	Drug Research Services, Inc.	Metairie	Louisiana
United States	Glenn Gordon, MD	Mexico	Missouri
United States	Wisconsin Center for Advanced Research	Milwaukee	Wisconsin
United States	Nashville Medical Research Institute	Nashville	Tennessee
United States	LSU School of Medicine	New Orleans	Louisiana
United States	Daniel Present	New York	New York
United States	New York Presbyterian Hospital	New York	New York
United States	Oklahoma Foundation for Digestive Disease	Oklahoma City	Oklahoma
United States	Peter Molloy, MD	Pittsburgh	Pennsylvania
United States	Mayo Clinic and Mayo Foundation	Rochester	Minnesota
United States	Rochester Institute for Digestive Diseases	Rochester	New York
United States	Sharp Rees-Stealy Medical Group	San Diego	California
United States	Southeastern Digestive & Liver Disease	Savannah	Georgia
United States	Inland Empire Gastroenterology	Spokane	Washington
United States	Tacoma Digestive Disease Center	Tacoma	Washington
United States	Research Solutions	Tulsa	Oklahoma
United States	Cleveland Clinic Florida	Weston	Florida
United States	Wake Research Associates	Weston	Florida
United States	Digestive Health Specialists	Winston-Salem	North Carolina
United States	Shafran Gastroenterology Center	Winter Park	Florida
United States	Clinical Pharmacology Study Group	Worchester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Randomized Participants Achieving Clinical Remission at Week 56 - Non-Responder Imputation (NRI)	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.	Week 56	No
Primary	Number of Randomized Participants Achieving Clinical Remission at Week 56 - Last Observation Carried Forward (LOCF)	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.	Week 56	No
Secondary	Number of Participants Achieving Clinical Remission at Week 24 - NRI	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.	Week 24	No
Secondary	Number of OL Participants Achieving Clinical Remission at Week 56 - NRI	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.	Week 56	No
Secondary	Number of Participants Achieving Clinical Response 100 (CR-100) - NRI	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.	From Baseline of lead-in study to Week 24 and Week 56	No
Secondary	Number of Participants Achieving Clinical Response 70 (CR-70)- NRI	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.	From Baseline of lead-in study to Week 24 and to Week 56	No
Secondary	Number of Participants Achieving Clinical Remission at Week 24 - LOCF	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.	Week 24	No
Secondary	Number of OL Participants Achieving Clinical Remission at Week 56 - LOCF	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.	Week 56	No
Secondary	Number of Participants Achieving CR-100 - LOCF	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.	From Baseline of lead-in study to Week 24 and Week 56	No
Secondary	Number of Participants Achieving CR-70 - LOCF	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.	From Baseline of lead-in study to Week 24 and Week 56	No
Secondary	Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores - LOCF	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.	Change from Baseline of lead-in study to Week 24 and Week 56	No