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

NCT ID: NCT00427921

Last Updated: 2009-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 304 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2008-01-31

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.

Conditions

Crohn's Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Open Label

Group Type: EXPERIMENTAL

adalimumab

Intervention Type: BIOLOGICAL

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

Interventions

adalimumab

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

Intervention Type: BIOLOGICAL

Other Intervention Names

ABT-D2E7; Humira

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: lead

Responsible Party

Abbott

Principal Investigators

Jimmy Baloukas

Role: STUDY_DIRECTOR

Abbott

Remo Panaccione, MD, FRCPC

Role: STUDY_CHAIR

Director, Inflammatory Bowel Disease Clinic, Associate Professor of Medicine, University of Calgary, Calgary, AB, Canada

Locations

Global Medical Information - Abbott

Abbott Park, Illinois, United States

Countries

United States

Related Links

http://www.humira.com/

For more information, see attached website

Other Identifiers

W06-405

Identifier Type: -

Identifier Source: org_study_id