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

NCT00427921 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2009-11-20

Study results available
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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

Interventions

BIOLOGICAL

adalimumab

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

Sponsors & Collaborators

Principal Investigators

  • Jimmy Baloukas · Abbott

  • Remo Panaccione, MD, FRCPC · Director, Inflammatory Bowel Disease Clinic, Associate Professor of Medicine, University of Calgary, Calgary, AB, Canada

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2008-01-31
Completion
2008-01-31

Countries

  • United States

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00427921 on ClinicalTrials.gov