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NCT01606761 - A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Rheumatoid Arthritis Despite Anti-TNF-Al

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of CNTO 136 (Sirukumab), a Human Anti-IL-6 Monoclonal Antibody, Administered Subcutaneously, in Subjects With Active Rheumatoid Arthritis Despite Anti-TNF-Alpha Therapy


CSR Summary

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Data Specification

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Annotated CRF

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Product Info

Generic Name
Sirukumab
Product Name
PLIVENSIA
Therapeutic Area
Muscle, Bone, and Cartilage Diseases
Enrollment
878
% Female
81.1%
% White
75.3%
Product Class
Antirheumatic Agents - Biologic Response Modifiers
Sponsor Protocol Number
CNTO136ARA3003
Data Holder
Johnson & Johnson
Condition Studied
Arthritis, Rheumatoid
Mean/Median Age (Years)
55.4

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.