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NCT00207714 - A Randomized, Double-blind, Dose-ranging Trial of CNTO 148 Subcutaneous Injection Compared With Placebo in Subjects With Active Rheumatoid Arthritis Despite Treatment With Methotrexate

A Randomized, Double-blind, Dose-ranging Trial of CNTO 148 Subcutaneous Injection Compared With Placebo in Subjects With Active Rheumatoid Arthritis Despite Treatment With Methotrexate


CSR Summary

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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
Muscle, Bone, and Cartilage Diseases
Enrollment
172
% Female
76.7%
% White
N/A
Product Class
Antirheumatic Agents - Biologic Response Modifiers
Sponsor Protocol Number
C0524T02
Data Holder
Johnson & Johnson
Condition Studied
Arthritis, Rheumatoid
Mean/Median Age (Years)
54.2

Supporting Documentation

Clinical Study Report
Collected Datasets
Data Definition Specification
Protocol with Amendments
Statistical Analysis Plan
Study Phase 
2

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.