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NCT01453725 - A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Effect of Golimumab Administered Subcutaneously in Subjects With Active Axial Spondyloarthritis (Also Known as MK-8259-006-02)

A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Effect of Golimumab Administered Subcutaneously in Subjects With Active Axial Spondyloarthritis (Also Known as MK-8259-006-02)


CSR Summary

Not Yet Available


Data Specification

Available upon data request approval


Annotated CRF

Available upon data request approval

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Operations

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Product Info

Generic Name
Golimumab
Product Name
SIMPONIĀ®
Therapeutic Area
Muscle, Bone, and Cartilage Diseases
Enrollment
198
% Female
42.9%
% White
100.0%
Product Class
Antirheumatic Agents - Biologic Response Modifiers
Sponsor Protocol Number
P07642Ā 
Data Holder
Johnson & Johnson
Condition Studied
Spondylitis, Ankylosing (Nonradiographic Axial)
Mean/Median Age (Years)
31.2

Supporting Documentation

Data Definition Specification Available
Annotated Case Report Form Available
Clinical Study Report
Collected Datasets
Data Definition Specification
Protocol with Amendments
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.