Status:
COMPLETED
Study of Adalimumab Treatment for Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease
Lead Sponsor:
Abbott
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety of adalimumab for treatment of patients with moderate to severe Crohn's Disease (CD) and to measure the effects of treatment on patient general well...
Detailed Description
This is an open-label, multi-center, study designed to evaluate the safety and efficacy of adalimumab on inducing and maintaining clinical remission in subjects with moderate to severe Crohn's Disease...
Eligibility Criteria
Inclusion
- Diagnosis of moderate to severe Crohn's Disease confirmed by endoscopy or radiologic evaluation for greater than 4 months (16 weeks)
- Inadequate response to conventional therapy for Crohn's Disease
- Subjects \>=18 and \<=75 years of age and in good health (Investigator discretion) with a recent stable medical history
- Harvey Bradshaw Index score of 7 or higher
Exclusion
- Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
- 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
- Female subject who is pregnant or breast-feeding or considering becoming pregnant
- Previous treatment with adalimumab or previous participation in an adalimumab clinical study
- Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
- Subjects with any prior exposure to Tysabri® (natalizumab)
- Subjects on prednisone \>40 mg/day (or equivalent), subjects on budesonide \>9 mg/day, or subjects who are taking prednisone and budesonide concurrently at Baseline
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
945 Patients enrolled
Trial Details
Trial ID
NCT00409617
Start Date
December 1 2006
End Date
July 1 2008
Last Update
October 10 2011
Active Locations (189)
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1
Site Ref # / Investigator 3077
Graz, Austria, 8036
2
Site Ref # / Investigator 2978
Vienna, Austria, 1030
3
Site Ref # / Investigator 2975
Vienna, Austria, 1060
4
Site Ref # / Investigator 2976
Vienna, Austria, 1090