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

Lancet
Kristin K JørgensenNOR-SWITCH study group

Abstract

TNF inhibitors have improved treatment of Crohn's disease, ulcerative colitis, spondyloarthritis, rheumatoid arthritis, psoriatic arthritis, and chronic plaque psoriasis, but are expensive therapies. The aim of NOR-SWITCH was to examine switching from originator infliximab to the less expensive biosimilar CT-P13 regarding efficacy, safety, and immunogenicity. The study is a randomised, non-inferiority, double-blind, phase 4 trial with 52 weeks of follow-up. Adult patients on stable treatment with infliximab originator treated in a hospital setting for at least 6 months were eligible for participation. Patients with informed consent were randomised in a 1:1 ratio to either continued infliximab originator or to switch to CT-P13 treatment, with unchanged dosing regimen. Data were collected at infusion visits in 40 Norwegian study centres. Patients, assessors, and patient care providers were masked to treatment allocation. The primary endpoint was disease worsening during 52-week follow-up. 394 patients in the primary per-protocol set were needed to show a non-inferiority margin of 15%, assuming 30% disease worsening in each group. This trial is registered with ClinicalTrials.gov, number NCT02148640. Between Oct 24, 2014, and July ...Continue Reading

Associated Clinical Trials

May 28, 2014·Tore K Kvien

References

Nov 3, 2015·The British Journal of Dermatology·A BlauveltJ J Wu

❮ Previous
Next ❯

Citations

Sep 18, 2016·The British Journal of Dermatology·A BlauveltJ J Wu
Jul 6, 2017·Nature Reviews. Gastroenterology & Hepatology·Silvio Danese, Laurent Peyrin-Biroulet
Sep 22, 2017·International Journal of Molecular Sciences·Grainne HolleranFranco Scaldaferri
Nov 7, 2017·International Journal of Molecular Sciences·Kirsten Rønholt, Lars Iversen
Jan 10, 2018·The British Journal of Dermatology·B Kirby
Apr 19, 2018·The British Journal of Dermatology·J Galloway, S Walsh
Oct 13, 2017·Alimentary Pharmacology & Therapeutics·G FiorinoS Danese
Feb 8, 2018·Clinical Rheumatology·Bassel El ZorkanyHani Al Moallim
Apr 25, 2018·Future Oncology·Barbara MeloskyIra Jacobs
Apr 25, 2018·Expert Opinion on Biological Therapy·Zsuzsanna KurtiPeter L Lakatos
Apr 24, 2018·Expert Opinion on Biological Therapy·Alexis JonesPedro M Machado
Mar 8, 2018·Alimentary Pharmacology & Therapeutics·M P Sparrow
Feb 8, 2018·Applied Health Economics and Health Policy·Don HusereauCarl Selya-Hammer
Nov 4, 2017·Nature Reviews. Rheumatology·Roy Fleischmann
Feb 16, 2018·Alimentary Pharmacology & Therapeutics·A A van Bodegraven, N W Boone
Nov 28, 2017·Journal of Comparative Effectiveness Research·Dae Hyun Yoo
Nov 28, 2017·Journal of Managed Care & Specialty Pharmacy·Jesse PetersonAl Heaton
Aug 28, 2017·Archives of Disease in Childhood·Nicolino RupertoUNKNOWN Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group
May 24, 2018·Expert Opinion on Biological Therapy·Annunziata RaimondoNicola Balato
Jun 2, 2018·Future Oncology·Yelena Y JanjigianMark Latymer
Feb 28, 2018·Future Oncology·Francisco J EstevaJustin Stebbing
May 29, 2018·Annals of Clinical Biochemistry·J G Sanchez-HernandezM V Calvo
Jun 20, 2018·Expert Review of Clinical Immunology·Dae Hyun YooChang-Hee Suh
Aug 21, 2018·Expert Opinion on Drug Discovery·Dinesh AggarwalSonya Abraham
Aug 18, 2018·Expert Review of Clinical Immunology·Lieven PouillonLaurent Peyrin-Biroulet
Sep 18, 2018·The British Journal of Dermatology·A Cline, S R Feldman
Sep 25, 2018·Journal of Managed Care & Specialty Pharmacy·Johlee S OdinetGregory A Heindel
Apr 27, 2018·Journal of Pediatric Gastroenterology and Nutrition·Neil ChanchlaniRichard K Russell

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.