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NCT00975130 - An Open-Label Study Assessing the Addition of Subcutaneous Golimumab (GLM) to Conventional Disease-Modifying Antirheumatic Drug (DMARD) Therapy in Biologic-Naïve Subjects With Rheumatoid Arthritis (Part 1), Followed by a Randomized Study

An Open-Label Study Assessing the Addition of Subcutaneous Golimumab (GLM) to Conventional Disease-Modifying Antirheumatic Drug (DMARD) Therapy in Biologic-Naïve Subjects With Rheumatoid Arthritis (Part 1), Followed by a Randomized Study Assessing the Value of Combined Intravenous and Subcutaneous GLM Administration Aimed at Inducing and Maintaining Remission


CSR Summary

Not Yet Available


Data Specification

Available upon data request approval


Annotated CRF

Available upon data request approval

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Product Info

Generic Name
Golimumab
Product Name
SIMPONI®
Therapeutic Area
Muscle, Bone, and Cartilage Diseases
Enrollment
3,366
% Female
82.8%
% White
69.6%
Product Class
Antirheumatic Agents - Biologic Response Modifiers
Sponsor Protocol Number
P06129
Data Holder
Johnson & Johnson
Condition Studied
Arthritis, Rheumatoid
Mean/Median Age (Years)
53.0

Supporting Documentation

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