Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease

Abbott

Status and phase

Completed

Phase 3

Conditions

Crohn's Disease

Treatments

Drug: Adalimumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00105300

M04-691

Details and patient eligibility

About

The goal of this study is to test whether adalimumab can induce clinical remission in subjects with active Crohn's disease who have been initially treated with infliximab and either lost response or discontinued its use as a result of intolerance to the drug.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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