Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
482 participants
INTERVENTIONAL
2014-10-31
2017-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CT-P13
Infusions of biosimilar infliximab (Remsima) with same dose and frequency as pre-inclusion treatment with innovator infliximab (Remicade)
Biosimilar infliximab
INX
Continued infusions of innovator infliximab (Remicade) with same dose and frequency as prior to inclusion
Innovator infliximab
Interventions
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Innovator infliximab
Biosimilar infliximab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Male or non-pregnant, non-nursing female
3. \>18 years of age at screening
4. Stable treatment with innovator infliximab (Remicade) during the last 6 months
5. Subject capable of understanding and signing an informed consent form
6. Provision of written informed consent
Exclusion Criteria
2. Change of major co-medication during the last 2 months prior to randomization:
RA, SpA and PsA: Initiation of systemic corticosteroids or synthetic DMARDs or other medication which according to the investigator would interfere with the stability of the disease.
UC and CD: Initiation of systemic corticosteroids or an immunosuppressant or other medication which according to the investigator would interfere with the stability of the disease Psoriasis: Initiation of synthetic DMARDs or other medication which according to the investigator would interfere with the stability of the disease
3. Inadequate birth control, pregnancy, and/or breastfeeding
4. Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol impossible
5. Change in treatment with innovator infliximab (Remicade) during the last 6 months due to disease related factors, not including dose/frequency adjustments due to drug concentration measurements
18 Years
ALL
No
Sponsors
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South-Eastern Norway Regional Health Authority
OTHER
Diakonhjemmet Hospital
OTHER
Responsible Party
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Tore K Kvien
Prof. Dr. Med.
Principal Investigators
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Tore K. Kvien, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Diakonhjemmet Hospital
Locations
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Sørlandet Sykehus HF
Arendal, , Norway
Ålesund Sjukehus, Helse Møre og Romsdal HF
Ålesund, , Norway
Haukeland Universitetssjukehus Hf
Bergen, , Norway
Haukeland Universitetssykehus
Bergen, , Norway
Nordlandssykehuset
Bodø, , Norway
Sykehuset Innlandet
Elverum, , Norway
Sykehuset Østfold HF
Fredrikstad, , Norway
Helse Førde Hf
Førde, , Norway
Bærum Sykehus
Gjettum, , Norway
Sykehuset Innlandet
Gjøvik, , Norway
Sykehuset Innlandet
Hamar, , Norway
Haugesund Sanitetsforenings Revmatismesykehus
Haugesund, , Norway
Helse Fonna HF
Haugesund, , Norway
Sørlandet Sykehus HF
Kristiansand, , Norway
Helse Nord-Trøndelag
Levanger, , Norway
Revmatismesykehuset Lillehammer
Lillehammer, , Norway
Sykehuset Innlandet
Lillehammer, , Norway
Akershus Universitetssykehus
Lørenskog, , Norway
Helgelandssykehuset
Mo i Rana, , Norway
Department of Rheumatology, Diakonhjemmet Hospital
Oslo, , Norway
Diakonhjemmet Hospital
Oslo, , Norway
Oslo Universitetssykehus, Rikshospitalet
Oslo, , Norway
Oslo Universitetssykehus, Ullevål
Oslo, , Norway
Martina Hansens Hospital
Sandvika, , Norway
Betanien Hospital
Skien, , Norway
Sykehuset Telemark HF
Skien, , Norway
Universitetssykehuset i Nord-Norge
Tromsø, , Norway
St. Olavs Hospital HF
Trondheim, , Norway
St. Olavs Hospital
Trondheim, , Norway
Sykehuset Vestfold
Tønsberg, , Norway
Countries
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References
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Jorgensen KK, Goll GL, Sexton J, Bolstad N, Olsen IC, Asak O, Berset IP, Blomgren IM, Dvergsnes K, Florholmen J, Frigstad SO, Henriksen M, Hagfors J, Huppertz-Hauss G, Haavardsholm EA, Klaasen RA, Moum B, Noraberg G, Prestegard U, Rydning JH, Sagatun L, Seeberg KA, Torp R, Vold C, Warren DJ, Ystrom CM, Lundin KEA, Kvien T, Jahnsen J. 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. BioDrugs. 2020 Oct;34(5):681-694. doi: 10.1007/s40259-020-00438-7.
Goll GL, Jorgensen KK, Sexton J, Olsen IC, Bolstad N, Haavardsholm EA, Lundin KEA, Tveit KS, Lorentzen M, Berset IP, Fevang BTS, Kalstad S, Ryggen K, Warren DJ, Klaasen RA, Asak O, Baigh S, Blomgren IM, Brenna O, Bruun TJ, Dvergsnes K, Frigstad SO, Hansen IM, Hatten ISH, Huppertz-Hauss G, Henriksen M, Hoie SS, Krogh J, Midtgard IP, Mielnik P, Moum B, Noraberg G, Poyan A, Prestegard U, Rashid HU, Strand EK, Skjetne K, Seeberg KA, Torp R, Ystrom CM, Vold C, Zettel CC, Waksvik K, Gulbrandsen B, Hagfors J, Mork C, Jahnsen J, Kvien TK. Long-term efficacy and safety of biosimilar infliximab (CT-P13) after switching from originator infliximab: open-label extension of the NOR-SWITCH trial. J Intern Med. 2019 Jun;285(6):653-669. doi: 10.1111/joim.12880. Epub 2019 Apr 12.
Jorgensen KK, Olsen IC, Goll GL, Lorentzen M, Bolstad N, Haavardsholm EA, Lundin KEA, Mork C, Jahnsen J, Kvien TK; NOR-SWITCH study group. 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. 2017 Jun 10;389(10086):2304-2316. doi: 10.1016/S0140-6736(17)30068-5. Epub 2017 May 11.
Other Identifiers
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2014-002056-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
DIA2014-01
Identifier Type: -
Identifier Source: org_study_id