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NCT00096655 - A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients With Active Ulcerative Colitis

A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients With 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
364
Product Class
Antirheumatic agents - biologic response modifiers
Sponsor Protocol Number
C0168T46
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
Additional Information: 

CSR Summary for study through extension week E-24 available here

CSR Summary for entire study extension available here

Disclaimer

Clinical study data provided through this site do not replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, health care professionals should consult the current prescribing information approved in their country. Patients seeking information may consult with their health care professional about the product, for which health authority approved written patient information may be available.