Trial Information
Generic NameGolimumabProduct NameSIMPONI®Therapeutic AreaMuscle, Bone, and Cartilage DiseasesEnrollment407% Female39.8%% White97%
Product ClassAntirheumatic Agents - Biologic Response ModifiersSponsor Protocol NumberC0524T08Data PartnerJohnson & JohnsonCondition StudiedArthritis, PsoriaticMean/Median Age (Years)47
Supporting Documentation
- Data Definition Specification Available
- Protocol with Amendments Available
- Statistical Analysis Plan Available
- Clinical Study Report Available
Approved Data Requests Associated with this Trial
- 2024-0436 : EXploring SEx-related Mechanisms of Psoriatic Arthritis response to advanced therapies (EXSEMP): Individual participant data (IPD) meta-analysis
- 2020-4341 : Estimating the association between TNF inhibitors and Legionnaires' disease and Listeriosis: A Meta-analysis
- 2018-3765 : Predictors of therapeutic and adverse effect outcomes of golimumab
- 2017-1746 : Heterogeneity in relative treatment efficacy by age, sex, socioeconomic status and comorbidity
- 2017-1456 : The efficacy of biologic medications in improving depressive symptoms in patients with PsA ? Patient-level meta-analysis
- 2016-0995 : Identifying the optimal target for Psoriatic Arthritis: a retrospective analysis to identify which target best predicts improved long term outcomes
- 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
- 2015-0560 : Construct and Content Validity of Instruments Used in Clinical Trials of Psoriatic Arthritis
- 2015-0339 : Impact of the dose of immunomodulators on pharmacokinetics of biologics: Patient level meta-analysis of randomized controlled trials