Clinical trial NCT00427921: Human Anti-TNF Monoclonal Antibody Adalimumab in Canadian Subjects With Moderate to Severe Crohn's Disease (ACCESS)
Official title: A Multicentre, Open Label, Treatment Protocol of the Human Anti-TNF Monoclonal Antibody Adalimumab in Canadian Subjects With Moderate to Severe Crohn's Disease (ACCESS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn's Disease
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2007-01-29
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To make adalimumab available to subjects suffering from moderately to severely active Crohn's Disease (CD) and to expand the safety information on adalimumab. The study also assessed changes in Patient Reported Outcome Measures from baseline.

Detailed description: This was a Phase 3, multicenter, open-label, Early Access Study with an induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4 in subjects with moderately to severely active Crohn's Disease (CD) who were eligible to receive biologic therapy or who had failed to respond to, lost response to, or were intolerant to infliximab. Failure of prior therapy was determined by the Investigator. Subjects were to have an 8-week wash-out period prior to Baseline from the last dose of infliximab.

Eligibility criteria: Inclusion Criteria:

* Males or females 18 years of age and older
* Females: Not of childbearing potential OR Practicing approved birth control throughout the study and for 150 days after study completion
* Diagnosis of moderate to severe CD for greater than 16 weeks prior to screening; Crohn's Disease Activity Index score \> 220 OR Harvey Bradshaw Index equal to or higher than 7, and who are refractory to optimal conventional therapies such as, 5-aminosalicylic acid (5-ASA), glucocorticoids, and immunosuppressive therapies (azathioprine, 6-MP and MTX)
* Subjects who failed prior infliximab therapy (as determined by the primary investigator), including those who never clinically responded ("primary non-responders")

Exclusion Criteria:

* History of cancer other than some skin and cervical cancers
* History of opportunistic infections, central nervous system (CNS) demyelinating disease, chronic viral hepatitis, or untreated tuberculosis
* Subjects with other, poorly controlled medical conditions
* Subjects with any prior exposure to Tysabri® (natalizumab)
* Subjects who have received any investigational agent in the past 30 days or 5 half-lives prior to screening (whichever is longer)
* Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study

Primary outcomes:
measure: Mean Extent of Exposure - Duration in Days
timeFrame: Up to 24 weeks
measure: Total Number of Injections of Adalimumab
timeFrame: Up to 24 weeks
measure: Compliance With Number of Injections of Adalimumab. Compliance Corresponds to Patients Who Received Their Injections.
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Fistula Count Mean Change From Baseline (Change in Number of Fistulas From Baseline).
timeFrame: Week 12, Week 24, and Last Assessment Value (last nonmissing value)
measure: Overall Health Care Resource Utilization
timeFrame: Up to 24 weeks
measure: Employment Status: Number of Subjects Employed
timeFrame: Baseline, Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)
measure: 50% Improvement in Draining Fistula Count and Fistula Healing
timeFrame: Week 12, Week 24, Last Assessment Value (last nonmissing value)
measure: Work Productivity and Activity Impairment - Change From Baseline in Overall Work Impairment
timeFrame: Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)
measure: Hematology - Change From Baseline to Final Visit
timeFrame: Up to 24 weeks
measure: Clinical Chemistry - Change From Baseline to Final Visit
timeFrame: Up to 24 weeks
measure: Urinalysis - Change From Baseline to Final Visit
timeFrame: Up to 24 weeks
measure: Work Productivity and Activity Impairment - Change From Baseline in Absenteeism
timeFrame: Weeks 4, 8, 12, and 24, and Last Assessmentl Value (last nonmissing value)
measure: Work Productivity and Activity Impairment - Change From Baseline in Presenteeism
timeFrame: Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)
measure: Work Productivity and Activity Impairment - Change From Baseline in Activity Impairment
timeFrame: Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)
Other outcomes:
Locations:
city: Abbott Park
country: United States
facility: Global Medical Information - Abbott
state: Illinois
Study officials:
affiliation: Abbott
name: Jimmy Baloukas
role: STUDY_DIRECTOR
affiliation: Director, Inflammatory Bowel Disease Clinic, Associate Professor of Medicine, University of Calgary, Calgary, AB, Canada
name: Remo Panaccione, MD, FRCPC
role: STUDY_CHAIR
References: