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Biosimilar Infliximab

DRUG4 trials

Sponsors

Diakonhjemmet Hospital, Janssen Scientific Affairs, LLC, Hikma Pharmaceuticals LLC, Oslo University Hospital

Conditions

Arthritis, RheumatoidCrohn's DiseaseLow Back PainPsoriasis ChronicPsoriatic ArthritisRheumatoid ArthritisSpondyloarthritisUlcerative Colitis

Phase 3

BackToBasic: Infliximab in Chronic Low Back Pain and Modic Changes
CompletedNCT03704363
Oslo University HospitalLow Back Pain
Start: 2018-12-12End: 2023-09-29Updated: 2024-03-08

Phase 4

The NOR-SWITCH Study
CompletedNCT02148640
Diakonhjemmet HospitalCrohn's Disease, Psoriasis Chronic, Psoriatic Arthritis +3
Start: 2014-10-31End: 2017-01-31Updated: 2017-09-25

Unknown Phase

Comparative and Pragmatic Study of Golimumab Intravenous (IV) (Simponi Aria) Versus Infliximab (Remicade) in Rheumatoid Arthritis
CompletedNCT02728934
Janssen Scientific Affairs, LLCArthritis, Rheumatoid
Start: 2016-02-25End: 2020-01-31Updated: 2020-04-15
Safety Study of Remsima® (Infliximab) in Rheumatoid Arthritis Patients in Jordan
CompletedNCT03348046
Hikma Pharmaceuticals LLCRheumatoid Arthritis
Start: 2017-03-23End: 2019-04-14Updated: 2020-03-04

Related Papers

Effectiveness and safety of intravenous golimumab with and without concomitant methotrexate in patients with rheumatoid arthritis in the prospective, noninterventional AWARE study.
2023-03-272 citations
Response to Treatment with Intravenous Golimumab or Infliximab in Rheumatoid Arthritis Patients: PROMIS Results from the Real-World Observational Phase 4 AWARE Study.
2023-02-234 citations
Incidence of Infusion Reactions and Clinical Effectiveness of Intravenous Golimumab Versus Infliximab in Patients with Rheumatoid Arthritis: The Real-World AWARE Study.
2021-08-207 citations
The effect of infliximab in patients with chronic low back pain and Modic changes (the BackToBasic study): study protocol of a randomized, double blind, placebo-controlled, multicenter trial.
2020-10-2114 citations
Efficacy and Safety of CT-P13 in Inflammatory Bowel Disease after Switching from Originator Infliximab: Exploratory Analyses from the NOR-SWITCH Main and Extension Trials.
2020-10-0118 citations
The Clinical and Cost-Effectiveness of 4 Enzyme-Linked Immunosorbent Assay Kits for Monitoring Infliximab in Crohn Disease Patients: Protocol for a Validation Study.
2018-10-193 citations
Policy Options for Infliximab Biosimilars in Inflammatory Bowel Disease Given Emerging Evidence for Switching.
2018-06-018 citations
Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial.
2017-05-11532 citations
Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study.
2016-04-29187 citations
Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study.
2016-04-26148 citations
Comparable long-term efficacy, as assessed by patient-reported outcomes, safety and pharmacokinetics, of CT-P13 and reference infliximab in patients with ankylosing spondylitis: 54-week results from the randomized, parallel-group PLANETAS study.
2016-01-20108 citations