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NCT00207740 - A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Evaluating the Efficacy and Safety of CNTO 148 Administered Subcutaneously in Symptomatic Subjects With Severe Persistent Asthma

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study Evaluating the Efficacy and Safety of CNTO 148 Administered Subcutaneously in Symptomatic Subjects With Severe Persistent Asthma


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
Respiratory Tract (Lung and Bronchial) Diseases
Enrollment
309
% Female
56.0%
% White
88.0%
Product Class
Antirheumatic Agents - Biologic Response Modifiers
Sponsor Protocol Number
C0524T03
Data Holder
Johnson & Johnson
Condition Studied
Asthma
Mean/Median Age (Years)
50.1

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 
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.