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

Abbott

Status and phase

Completed

Phase 3

Conditions

Crohn's Disease

Treatments

Biological: adalimumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00427921

W06-405

Details and patient eligibility

About

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.

Full 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.

Enrollment

304 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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