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NCT00488774 - A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects With Moderately to Severely Active Ulcerative Colitis

A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects With Moderately to Severely Active Ulcerative Colitis


CSR Summary

Not Yet Available


Data Specification

Not Available


Annotated CRF

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Product Info

Generic Name
Golimumab
Product Name
SIMPONIĀ®
Therapeutic Area
Digestive System Diseases
Enrollment
291
% Female
40.2%
% White
82.1%
Product Class
Antirheumatic Agents - Biologic Response Modifiers
Sponsor Protocol Number
C0524T16
Data Holder
Johnson & Johnson
Condition Studied
Colitis, Ulcerative
Mean/Median Age (Years)
40.0

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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