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NCT00036387 - A Randomized, Double-blind Trial of the Safety of Anti-TNF Chimeric Monoclonal Antibody (Infliximab) in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Rheumatoid Arthritis on Standard Disease-modifying Anti-R

A Randomized, Double-blind Trial of the Safety of Anti-TNF Chimeric Monoclonal Antibody (Infliximab) in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Rheumatoid Arthritis on Standard Disease-modifying Anti-Rheumatic Drug


CSR Summary

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Data Specification

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Annotated CRF

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Product Info

Generic Name
Infliximab
Product Name
REMICADE®
Therapeutic Area
Muscle, Bone, and Cartilage Diseases
Enrollment
347
% Female
80.4%
% White
N/A
Product Class
Antirheumatic Agents - Biologic Response Modifiers
Sponsor Protocol Number
C0168T41
Data Holder
Johnson & Johnson
Condition Studied
Arthritis, Rheumatoid
Mean/Median Age (Years)
52.0

Supporting Documentation

Analysis Datasets
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 
4

Disclaimer

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