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

NCT00427921 | Completed Phase 3 Results

• 1 other identifier: W06-405
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (3)

• Mean Extent of Exposure - Duration in Days

  Extent of exposure for all adalimumab treated subjects

  Up to 24 weeks

• Total Number of Injections of Adalimumab

  Extent of exposure for all adalimumab treated subjects

  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).

  Up to 24 weeks

Secondary Outcomes (11)

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

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

• Overall Health Care Resource Utilization

  Up to 24 weeks

• Employment Status: Number of Subjects Employed

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

• 50% Improvement in Draining Fistula Count and Fistula Healing

  Week 12, Week 24, Last Assessment Value (last nonmissing value)

• Work Productivity and Activity Impairment - Change From Baseline in Overall Work Impairment

  Weeks 4, 8, 12, and 24, and Last Assessment Value (last nonmissing value)

Study Arms (1)

1

EXPERIMENTAL

Open Label

Biological: adalimumab

Interventions

adalimumab BIOLOGICAL

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

Also known as: ABT-D2E7, Humira

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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")

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott: lead

Study Sites (1)

Global Medical Information - Abbott

Abbott Park, Illinois, 60064, United States

Location

Related Links

• For more information, see attached website

MeSH Terms

Conditions

Crohn Disease

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

Subjects who failed prior infliximab therapy were eligible to enter study after minimum 8 week wash-out since last dose. Includes subjects who previously used infliximab \& never responded or responded \& developed intolerance/lost efficacy.

Results Point of Contact

• Title: Medical Information Specialist
• Organization: Abbott Laboratories

Phone: (800) 633-9110

Study Officials

• Jimmy Baloukas

  Abbott

  STUDY DIRECTOR

• Remo Panaccione, MD, FRCPC

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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 26, 2007
• First Posted: January 29, 2007
• Study Start: January 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: November 20, 2009
• Results First Posted: October 23, 2009

Record last verified: 2009-11

Locations

US (1)