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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

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Data Specification

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Annotated CRF

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Product Info

Generic Name
Golimumab
Product Name
SIMPONIĀ®
Therapeutic Area
Digestive System Diseases
Enrollment
1,065
Product Class
Antirheumatic agents - biologic response modifiers
Sponsor Protocol Number
C0524T17
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

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.