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Trial Information
Generic NameInfliximabProduct NameREMICADE®Therapeutic AreaMuscle, Bone, and Cartilage DiseasesEnrollment428% Female77.6%% White90.9%
Product ClassAntirheumatic Agents - Biologic Response ModifiersSponsor Protocol NumberC0168T22Data PartnerJohnson & JohnsonCondition StudiedArthritis, RheumatoidMean/Median Age (Years)53.5
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
- 2023-5446 : Bayesian nonparametric methods for pediatric extrapolation
- 2022-5102 : Disease-modifying anti-rheumatic drugs for rheumatoid arthritis: A network meta-analysis incorporating individual patient data
- 2022-5060 : A meta-analysis to assess relationships between patient demographics and response to antibody-based treatment in rheumatoid arthritis patients
- 2022-4961 : Efficacy and safety of tumor necrosis factor inhibitors (TNFi) in seronegative rheumatoid arthritis patients who are inadequate responders to csDMARDs
- 2021-4715 : Disease-modifying anti-rheumatic drugs for rheumatoid arthritis: A network meta-analysis incorporating individual patient data
- 2020-4341 : Estimating the association between TNF inhibitors and Legionnaires' disease and Listeriosis: A Meta-analysis
- 2019-4092 : Cross-Trial Comparisons of Biologic Therapies for Auto-Immune Diseases
- 2019-4067 : Evidence-generation for biologics in pediatric studies
- 2018-2931 : Influence of demographic and environmental factors on anti-TNF efficacy in rheumatoid arthritis: a systematic review and meta-analysis of RCT
- 2017-1451 : Long-term Impact of Patient Global Assessment on radiographic damage and physical function in patients with RA in Remission vs "near-remission"
- 2016-1196 : From clinical trials to routine care: understanding patient response to biologics in rheumatoid arthritis.
- 2016-0698 : Placebo response in rheumatoid arthritis
- 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