The NOR-SWITCH Study

Last updated: September 22, 2017
Sponsor: Diakonhjemmet Hospital
Overall Status: Completed

Phase

4

Condition

Rheumatoid Arthritis

Ankylosing Spondylitis

Arthritis And Arthritic Pain

Treatment

N/A

Clinical Study ID

NCT02148640
DIA2014-01
2014-002056-40
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. A clinical diagnosis of either rheumatoid arthritis, spondyloarthritis, psoriaticarthritis, ulcerative colitis, Crohn's disease or chronic plaque psoriasis

  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

Exclusion Criteria:

  1. Major co-morbidities, such as severe malignancies, severe diabetic mellitus, severeinfections, uncontrollable hypertension, severe cardiovascular disease (NYHA class 3or 4) and/or severe respiratory diseases

  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 othermedication which according to the investigator would interfere with the stability ofthe disease. UC and CD: Initiation of systemic corticosteroids or an immunosuppressant or othermedication which according to the investigator would interfere with the stability ofthe disease Psoriasis: Initiation of synthetic DMARDs or other medication whichaccording 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, languagebarriers or other factors which makes adherence to the study protocol impossible

  5. Change in treatment with innovator infliximab (Remicade) during the last 6 months dueto disease related factors, not including dose/frequency adjustments due to drugconcentration measurements

Study Design

Total Participants: 482
Study Start date:
October 01, 2014
Estimated Completion Date:
January 31, 2017

Connect with a study center

  • Sørlandet Sykehus HF

    Arendal,
    Norway

    Site Not Available

  • Haukeland Universitetssjukehus Hf

    Bergen,
    Norway

    Site Not Available

  • Haukeland Universitetssykehus

    Bergen,
    Norway

    Site Not Available

  • Nordlandssykehuset

    Bodø,
    Norway

    Site Not Available

  • Sykehuset Innlandet

    Elverum,
    Norway

    Site Not Available

  • Sykehuset Østfold HF

    Fredrikstad,
    Norway

    Site Not Available

  • Helse Førde Hf

    Førde,
    Norway

    Site Not Available

  • Bærum Sykehus

    Gjettum,
    Norway

    Site Not Available

  • Sykehuset Innlandet

    Gjøvik,
    Norway

    Site Not Available

  • Sykehuset Innlandet

    Hamar,
    Norway

    Site Not Available

  • Haugesund Sanitetsforenings Revmatismesykehus

    Haugesund,
    Norway

    Site Not Available

  • Helse Fonna HF

    Haugesund,
    Norway

    Site Not Available

  • Sørlandet Sykehus HF

    Kristiansand,
    Norway

    Site Not Available

  • Helse Nord-Trøndelag

    Levanger,
    Norway

    Site Not Available

  • Revmatismesykehuset Lillehammer

    Lillehammer,
    Norway

    Site Not Available

  • Sykehuset Innlandet

    Lillehammer,
    Norway

    Site Not Available

  • Akershus Universitetssykehus

    Lørenskog,
    Norway

    Site Not Available

  • Helgelandssykehuset

    Mo i Rana,
    Norway

    Site Not Available

  • Department of Rheumatology, Diakonhjemmet Hospital

    Oslo, 0319
    Norway

    Site Not Available

  • Diakonhjemmet Hospital

    Oslo,
    Norway

    Site Not Available

  • Oslo Universitetssykehus, Rikshospitalet

    Oslo,
    Norway

    Site Not Available

  • Oslo Universitetssykehus, Ullevål

    Oslo,
    Norway

    Site Not Available

  • Martina Hansens Hospital

    Sandvika,
    Norway

    Site Not Available

  • Betanien Hospital

    Skien,
    Norway

    Site Not Available

  • Sykehuset Telemark HF

    Skien,
    Norway

    Site Not Available

  • Universitetssykehuset i Nord-Norge

    Tromsø,
    Norway

    Site Not Available

  • St. Olavs Hospital

    Trondheim,
    Norway

    Site Not Available

  • St. Olavs Hospital HF

    Trondheim,
    Norway

    Site Not Available

  • Sykehuset Vestfold

    Tønsberg,
    Norway

    Site Not Available

  • Ålesund Sjukehus, Helse Møre og Romsdal HF

    Ålesund,
    Norway

    Site Not Available

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