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NCT00336492 - A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE) in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis

A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE) in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis

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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
60
Product Class
Antirheumatic agents - biologic response modifiers
Sponsor Protocol Number
C0168T72
Data Holder
Johnson & Johnson
Condition Studied
Colitis, Ulcerative

Supporting Documentation

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

Disclaimer

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