Human Anti-TNF Monoclonal Antibody Adalimumab in Canadian Subjects With Moderate to Severe Crohn's Disease (ACCESS)

Abbott304 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

304

Conditions

Crohn's Disease

Interventions

adalimumabBIOLOGICAL

160 mg loading dose, 80 mg at week 2, 40 mg every other week

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Global Medical Information - Abbott

Abbott Park, Illinois, United States

Outcomes

Primary Outcomes

Mean Extent of Exposure - Duration in Days

Extent of exposure for all adalimumab treated subjects

Time frame: Up to 24 weeks

Total Number of Injections of Adalimumab

Extent of exposure for all adalimumab treated subjects

Time frame: Up to 24 weeks

Compliance With Number of Injections of Adalimumab. Compliance Corresponds to Patients Who Received Their Injections.

Treatment compliance (%) = 100 \* (Number of doses of study medication actually received)/(Number of doses planned during the subject's participation in the study).

Time frame: Up to 24 weeks

Secondary Outcomes

Fistula Count Mean Change From Baseline (Change in Number of Fistulas From Baseline).

Draining fistula counts is the sum of abdominal and perianal fistulas for each subject at each visit.

Time frame: Week 12, Week 24, and Last Assessment Value (last nonmissing value)

Overall Health Care Resource Utilization

From the "Overall Health Care Resource Utilization Questionnaire": Number visits to physician, number visits to Emergency Room, number of hospital admissions, number of days of hospitalization.

Time frame: Up to 24 weeks

Employment Status: Number of Subjects Employed

Summary of employment status of those employed.

Time frame: Baseline, Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)

50% Improvement in Draining Fistula Count and Fistula Healing

Decrease in draining fistula is beneficial. "50 percent improvement" refers to a reduction in the number of baseline fistula by 50 percent.

Data from ClinicalTrials.gov

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