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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 19 February 2015
Main ID:  NCT00105300
Date of registration: 11/03/2005
Prospective Registration: No
Primary sponsor: Abbott
Public title: Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease
Scientific title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Moderate to Severe Crohn's Disease Who Have Lost Response or Are Intolerant to Infliximab
Date of first enrolment: October 2004
Target sample size: 300
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment  
Phase:  Phase 3
Countries of recruitment
Belgium Canada France United States
Name:     Global Medical Information 1-800-633-9110
Affiliation:  Abbott
Key inclusion & exclusion criteria

Inclusion Criteria:

- Males and females between the ages of 18 and 75 who are diagnosed with mild to
moderate Crohn's disease (defined by a CDAI [Crohn's Disease Activity Index] score of
220 and 450)

- Normal lab parameters

- Are willing to give informed consent

- Have previously used and either were intolerant to or lost response to infliximab

Exclusion Criteria:

- History of certain types of cancer

- Diagnosis of ulcerative colitis

- Pregnant female or breast feeding subjects

- Known obstructive strictures

- Surgical bowel resection in the past 6 months

- History of listeria, human immunodeficiency virus (HIV), central nervous system
demyelinating disease or untreated TB (tuberculosis)

- History of poorly controlled medical conditions

- Specific doses and durations of Crohn's medications

- Subjects that have previously used infliximab and have never clinically responded
unless primary non-response was due to a treatment limiting reaction to infliximab

Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Crohn's Disease
Drug: Adalimumab
Primary Outcome(s)
Induction of clinical remission (CDAI score < 150 at Week 4)
Secondary Outcome(s)
Changes in IBDQ scores at Week 4
Clinical response measured as
Decrease in Baseline CDAI score >= 100 points at Week 4
Decrease in Baseline CDAI score >= 70 points at Week 4
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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