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NCT00094458 - Multicenter, Randomized, Double-Blind, Active Controlled Trial Comparing REMICADE® (infliximab) and REMICADE plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic

Multicenter, Randomized, Double-Blind, Active Controlled Trial Comparing REMICADE® (infliximab) and REMICADE plus Azathioprine to Azathioprine in the Treatment of Patients with Crohn’s Disease Naive to both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Crohn’s Disease)

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Data Specification

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Annotated CRF

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Product Info

Generic Name
Infliximab
Product Name
REMICADE®
Therapeutic Area
Digestive System Diseases
Enrollment
508
% Female
48.4%
% White
92.8%
Product Class
Antirheumatic Agents - Biologic Response Modifiers
Sponsor Protocol Number
C0168T67
Data Holder
Johnson & Johnson
Condition Studied
Crohn's Disease
Mean/Median Age (Years)
34.0

Supporting Documentation

Data Definition Specification Available
Annotated Case Report Form Available
Clinical Study Report
Collected Datasets
Data Definition Specification
Protocol with Amendments
Statistical Analysis Plan
Study Phase 
3

Disclaimer

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