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NCT00487539 - A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, 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 Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis


Data Specification

Annotated CRF

Available upon data request approval

Product Info

Generic Name
Golimumab
Product Name
SIMPONIĀ®
Therapeutic Area
Digestive System Diseases
Enrollment
1,065
% Female
44.0%
% White
82.1%
Product Class
Antirheumatic Agents - Biologic Response Modifiers
Sponsor Protocol Number
C0524T17
Data Partner
Johnson & Johnson
Condition Studied
Colitis, Ulcerative
Mean/Median Age (Years)
38.0

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.