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NCT01369355 - A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease

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Data Specification

Not Available


Annotated CRF

Not Available

Product Info

Generic Name
Ustekinumab
Product Name
STELARA®
Therapeutic Area
Digestive System Diseases
Enrollment
1,309
% Female
56.4%
% White
84.9%
Product Class
Antirheumatic Agents - Biologic Response Modifiers
Sponsor Protocol Number
CNTO1275CRD3003
Data Holder
Johnson & Johnson
Condition Studied
Crohn's Disease
Mean/Median Age (Years)
36.0

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

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.