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NCT00036439 - 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

Available upon data request approval


Annotated CRF

Available upon data request approval

Product Info

Generic Name
Infliximab
Product Name
REMICADE®
Therapeutic Area
Digestive System Diseases
Enrollment
364
% Female
40.0%
% White
96.0%
Product Class
Antirheumatic Agents - Biologic Response Modifiers
Sponsor Protocol Number
C0168T37
Data Partner
Johnson & Johnson
Condition Studied
Colitis, Ulcerative
Mean/Median Age (Years)
40.0

Supporting Documentation

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

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.