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Trial Information
Generic NameGolimumabProduct NameSIMPONI®Therapeutic AreaMuscle, Bone, and Cartilage DiseasesEnrollment213% Female16.9%% WhiteN/A
Product ClassAntirheumatic Agents - Biologic Response ModifiersSponsor Protocol NumberC0524T29Data PartnerJohnson & JohnsonCondition StudiedSpondylitis, Ankylosing (Nonradiographic Axial)Mean/Median Age (Years)29
Supporting Documentation
- Collected Datasets Available
- Data Definition Specification Available
- Protocol with Amendments Available
- Statistical Analysis Plan Available
- Clinical Study Report Available
Approved Data Requests Associated with this Trial
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- 2020-4341 : Estimating the association between TNF inhibitors and Legionnaires' disease and Listeriosis: A Meta-analysis
- 2019-3893 : Predicting Treatment Response to Tumor Necrosis Factor Inhibitors in patients with ankylosing spondylitis
- 2018-3765 : Predictors of therapeutic and adverse effect outcomes of golimumab
- 2015-0691 : Impact of Biologic Therapy on the Risk of Arterial and Venous Thromboembolic Events in Chronic Autoimmune Diseases: A Post-Hoc Analysis of RCTs
- 2015-0339 : Impact of the dose of immunomodulators on pharmacokinetics of biologics: Patient level meta-analysis of randomized controlled trials
- 2014-0291 : Comparative effectiveness of tumor necrosis factor alpha inhibitors in ankylosing spondylitis