Clinical trial NCT00055497: Remission in Subjects With Crohn's Disease, 1 Year Phase
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn's Disease
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2003-03-05
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: Number of Randomized Participants Achieving Clinical Remission at Week 56 - Non-Responder Imputation (NRI)
timeFrame: Week 56
measure: Number of Randomized Participants Achieving Clinical Remission at Week 56 - Last Observation Carried Forward (LOCF)
timeFrame: Week 56
Secondary outcomes:
measure: Number of Participants Achieving Clinical Remission at Week 24 - NRI
timeFrame: Week 24
measure: Number of OL Participants Achieving Clinical Remission at Week 56 - NRI
timeFrame: Week 56
measure: Number of Participants Achieving Clinical Response 100 (CR-100) - NRI
timeFrame: From Baseline of lead-in study to Week 24 and Week 56
measure: Number of Participants Achieving Clinical Response 70 (CR-70)- NRI
timeFrame: From Baseline of lead-in study to Week 24 and to Week 56
measure: Number of Participants Achieving Clinical Remission at Week 24 - LOCF
timeFrame: Week 24
measure: Number of OL Participants Achieving Clinical Remission at Week 56 - LOCF
timeFrame: Week 56
measure: Number of Participants Achieving CR-100 - LOCF
timeFrame: From Baseline of lead-in study to Week 24 and Week 56
measure: Number of Participants Achieving CR-70 - LOCF
timeFrame: From Baseline of lead-in study to Week 24 and Week 56
measure: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores - LOCF
timeFrame: Change from Baseline of lead-in study to Week 24 and Week 56
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Gastroenterology Associates of the East Bay
state: California
city: Long Beach
country: United States
facility: Long Beach Gastroenterology Assoc.
state: California
city: San Diego
country: United States
facility: Sharp Rees-Stealy Medical Group
state: California
city: Bridgeport
country: United States
facility: Gastroenterology Assoc. of Fairfield Co.
state: Connecticut
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Weston
country: United States
facility: Wake Research Associates
state: Florida
city: Winter Park
country: United States
facility: Shafran Gastroenterology Center
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Assoc.
state: Georgia
city: Savannah
country: United States
facility: Southeastern Digestive & Liver Disease
state: Georgia
city: Arlington Heights
country: United States
facility: Northwest Gastroenterologists, S.C.
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Metairie
country: United States
facility: Drug Research Services, Inc.
state: Louisiana
city: New Orleans
country: United States
facility: LSU School of Medicine
state: Louisiana
city: Annapolis
country: United States
facility: Digestive Disorders Associates
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Worchester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic and Mayo Foundation
state: Minnesota
city: Kansas City
country: United States
facility: Gastroenterology and Hepatology
state: Missouri
city: Mexico
country: United States
facility: Glenn Gordon, MD
state: Missouri
city: Billings
country: United States
facility: Deaconess Billings Clinic Research Division
state: Montana
city: Lincoln
country: United States
facility: Gastroenterology Specialties, P.C.
state: Nebraska
city: Great Neck
country: United States
facility: Long Island Clinical Research Associates
state: New York
city: Lake Success
country: United States
facility: NY Center for Clinical Research
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Daniel Present
state: New York
city: Rochester
country: United States
facility: Rochester Institute for Digestive Diseases
state: New York
city: Chapel Hill
country: United States
facility: UNC School of Medicine
state: North Carolina
city: Charlotte
country: United States
facility: Charlotte Gastroenterology and Hepatology
state: North Carolina
city: Charlotte
country: United States
facility: Carolina Research Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Digestive Health Specialists
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants for Clinical Research
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Foundation for Digestive Disease
state: Oklahoma
city: Tulsa
country: United States
facility: Research Solutions
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Peter Molloy, MD
state: Pennsylvania
city: Chattanooga
country: United States
facility: Diseases of the Digestive System
state: Tennessee
city: Nashville
country: United States
facility: Nashville Medical Research Institute
state: Tennessee
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
city: Bellevue
country: United States
facility: Northwest Gastroenterology
state: Washington
city: Spokane
country: United States
facility: Inland Empire Gastroenterology
state: Washington
city: Tacoma
country: United States
facility: Tacoma Digestive Disease Center
state: Washington
city: Milwaukee
country: United States
facility: Wisconsin Center for Advanced Research
state: Wisconsin
Study officials:
affiliation: Abbott
name: Anne Camez, MD
role: STUDY_DIRECTOR
References:
citation: Ryan C, Sobell JM, Leonardi CL, Lynde CW, Karunaratne M, Valdecantos WC, Hendrickson BA. Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis. Am J Clin Dermatol. 2018 Jun;19(3):437-447. doi: 10.1007/s40257-017-0341-6.
citation: Steenholdt C, Al-khalaf M, Brynskov J, Bendtzen K, Thomsen OO, Ainsworth MA. Clinical implications of variations in anti-infliximab antibody levels in patients with inflammatory bowel disease. Inflamm Bowel Dis. 2012 Dec;18(12):2209-17. doi: 10.1002/ibd.22910. Epub 2012 Feb 16.