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NCT00207701 - A Randomized, Double-blind Trial of the Efficacy of REMICADE (Infliximab) Compared With Placebo in Subjects With Ankylosing Spondylitis Receiving Standard Anti-inflammatory Drug Therapy

A Randomized, Double-blind Trial of the Efficacy of REMICADE (Infliximab) Compared With Placebo in Subjects With Ankylosing Spondylitis Receiving Standard Anti-inflammatory Drug Therapy

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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
279
% Female
17.0%
% White
98.0%
Product Class
Antirheumatic Agents - Biologic Response Modifiers
Sponsor Protocol Number
C0168T51
Data Partner
Johnson & Johnson
Condition Studied
Spondylitis, Ankylosing (Nonradiographic Axial)
Mean/Median Age (Years)
40.0

Supporting Documentation

Clinical Study Report
Collected Datasets
Data Definition Specification
Annotated Case Report Form
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.