The NOR-SWITCH Study

NCT02148640 | Completed Phase 4

• 2 other identifiers: DIA2014-012014-002056-40
• Study Type: interventional
• Target: 482
• Locations: 1 country
• Sites: 30

Brief Summary

The purpose of this study is to assess the safety and efficacy of switching from Remicade to the biosimilar treatment Remsima in patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease and chronic plaque psoriasis

Conditions

Rheumatoid Arthritis; Spondyloarthritis; Psoriatic Arthritis; Ulcerative Colitis; Crohn's Disease; Psoriasis Chronic

Outcome Measures

Primary Outcomes (1)

• Occurrence of disease worsening

  A disease worsening in RA and PsA is defined as an increase in DAS28 of ≥ 1.2 from randomization and a minimum DAS score of 3.2. A disease worsening in AS/SpA is defined as an increase in ASDAS of ≥1.1 from randomization and a minimum ASDAS of 2.1. A disease worsening in ulcerative colitis is defined as an increase in Partial Mayo score of ≥ 3 points from randomization and a minimum partial Mayo score of ≥ 5 points. A disease worsening in Crohn's disease is defined as an increase in HBI of ≥ 4 points from randomization and a minimum HBI score of 7 points. A disease worsening in psoriasis is defined as an increase in PASI of ≥ 3 points from randomization and a minimum PASI score of 5. If a patient does not fulfill the formal definition, but experiences a clinically significant worsening according to both the investigator and patient and which leads to a major change in treatment this should be considered as a disease worsening but recorded separately in the CRF.

  52 weeks

Secondary Outcomes (22)

• Time to disease worsening

  52 weeks

• Occurrence of study drug discontinuation

  52 weeks

• Time to study drug discontinuation

  52 weeks

• Patient's global assessment of disease activity

  52 weeks

• Physicians's global assessment of disease activity

  52 weeks

Other Outcomes (9)

• RAND SF-36

  52 weeks

• Modified Health Assessment Questionnaire (MHAQ)

  52 weeks

• Inflammatory Bowel Disease Questionnaire (IBDQ)

  52 weeks

Study Arms (2)

CT-P13

EXPERIMENTAL

Infusions of biosimilar infliximab (Remsima) with same dose and frequency as pre-inclusion treatment with innovator infliximab (Remicade)

Drug: Biosimilar infliximab

INX

ACTIVE COMPARATOR

Continued infusions of innovator infliximab (Remicade) with same dose and frequency as prior to inclusion

Drug: Innovator infliximab

Interventions

Innovator infliximab DRUG

Also known as: Remicade

INX

Biosimilar infliximab DRUG

Also known as: Remsima

CT-P13

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A clinical diagnosis of either rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease or chronic plaque psoriasis
• Male or non-pregnant, non-nursing female
• \>18 years of age at screening
• Stable treatment with innovator infliximab (Remicade) during the last 6 months
• Subject capable of understanding and signing an informed consent form
• Provision of written informed consent

You may not qualify if:

• Major co-morbidities, such as severe malignancies, severe diabetic mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease (NYHA class 3 or 4) and/or severe respiratory diseases
• 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
• Inadequate birth control, pregnancy, and/or breastfeeding
• Psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol impossible
• 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

Sponsors & Collaborators

• Diakonhjemmet Hospital: lead
• South-Eastern Norway Regional Health Authority: collaborator

Study Sites (30)

Sørlandet Sykehus HF

Arendal, Norway

Location

Ålesund Sjukehus, Helse Møre og Romsdal HF

Ålesund, Norway

Location

Haukeland Universitetssjukehus Hf

Bergen, Norway

Location

Haukeland Universitetssykehus

Bergen, Norway

Location

Nordlandssykehuset

Bodø, Norway

Location

Sykehuset Innlandet

Elverum, Norway

Location

Sykehuset Østfold HF

Fredrikstad, Norway

Location

Helse Førde Hf

Førde, Norway

Location

Bærum Sykehus

Gjettum, Norway

Location

Sykehuset Innlandet

Gjøvik, Norway

Location

Sykehuset Innlandet

Hamar, Norway

Location

Haugesund Sanitetsforenings Revmatismesykehus

Haugesund, Norway

Location

Helse Fonna HF

Haugesund, Norway

Location

Sørlandet Sykehus HF

Kristiansand, Norway

Location

Helse Nord-Trøndelag

Levanger, Norway

Location

Revmatismesykehuset Lillehammer

Lillehammer, Norway

Location

Sykehuset Innlandet

Lillehammer, Norway

Location

Akershus Universitetssykehus

Lørenskog, Norway

Location

Helgelandssykehuset

Mo i Rana, Norway

Location

Department of Rheumatology, Diakonhjemmet Hospital

Oslo, 0319, Norway

Location

Diakonhjemmet Hospital

Oslo, Norway

Location

Oslo Universitetssykehus, Rikshospitalet

Oslo, Norway

Location

Oslo Universitetssykehus, Ullevål

Oslo, Norway

Location

Martina Hansens Hospital

Sandvika, Norway

Location

Betanien Hospital

Skien, Norway

Location

Sykehuset Telemark HF

Skien, Norway

Location

Universitetssykehuset i Nord-Norge

Tromsø, Norway

Location

St. Olavs Hospital HF

Trondheim, Norway

Location

St. Olavs Hospital

Trondheim, Norway

Location

Sykehuset Vestfold

Tønsberg, Norway

Location

Related Publications (3)

• 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.

  PMID: 32965617 DERIVED

• 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.

  PMID: 30762274 DERIVED

• 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.

  PMID: 28502609 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid; Spondylarthritis; Arthritis, Psoriatic; Colitis, Ulcerative; Crohn Disease

Interventions

Infliximab; CT-P13

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylitis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Tore K. Kvien, MD PhD

  Diakonhjemmet Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Med.

Study Record Dates

• First Submitted: May 23, 2014
• First Posted: May 28, 2014
• Study Start: October 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: January 1, 2017
• Last Updated: September 25, 2017

Record last verified: 2017-09

Locations

NO (30)