A Multi-Center, Open-Label Study of the Fully Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects with Moderate to Severe Crohn s Disease - CARE

Conditions: Crohn s disease
MedDRA version: 6.1Level: PTClassification code 10011401

Registration Number: EUCTR2006-002078-23-IT

Lead Sponsor: Abbott GmbH Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1000

Inclusion Criteria

1.Diagnosis of moderate to severe Crohn s Disease confirmed by endoscopy or radiologic evaluation for greater than 4 months 16 weeks . 2.Inadequate response to conventional therapy for Crohn s Disease in the opinion of and as documented by the treating physician. 3.Harvey Bradshaw Index score 7. 4.Males and females 18 and 75 years o age at the Baseline visit. 5.Negative pregnancy test 6.Use of reliable contraception 7.Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol 8.Adequate cardiac, renal and hepatic function as determined by the principal investigator and demonstrated by Screening laboratory evaluations, questionnaires, and physical examination results that are within normal limits. 9.Subjects must be able to self-inject study medication or have a designee or healthcare professional who can inject the study medication.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.History of cancer or lymphoproliferative disease other than a successfully and completely treated cutaneous squamous cell or basal cell carcinoma or carcinoma 8722; in-situ of the cervix. 2.History of listeria, human immunodeficiency virus HIV , chronic or active Hepatitis B, an immunodeficiency syndrome, central nervous system CNS demyelinating disease or active TB. 3.Subjects with abscess or suspicion of abscess. 4.Subject who has had surgical bowel resections within the past 6 months or is planning any resection at any time point while enrolled in the study. 5. Females who are pregnant or will not discontinue breast-feeding. 6.Subject who has an active infection or has had systemic antibiotic, antiviral, or antifungal treatment within 3 weeks prior to Baseline for infection. Subjects are allowed to be on ciprofloxacin or metronidazole for their non-infectious Crohn s symptoms. 7. Subject with a history of clinically significant drug or alcohol abuse in the last year. 8.Subjects with a poorly controlled medical condition. 9. Subjects with positive C. difficile stool assay. 10.Previous treatment with adalimumab or previous participation in an adalimumab clinical study. 11.Abnormal, clinically significant screening laboratory and other analyses including ECG . 12.Subjects with any prior exposure to Tysabri natalizumab .

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Further evaluation and deineation of safety and efficacy profile of Adalimumab in subjects with moderate to savere Crohn Disease;Secondary Objective: Not applicable;Primary end point(s): Long term safety and efficacy of Adalimumab in subjects with moderate to savere Crohn Disease

Secondary Outcome Measures