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Completed

NCT Number: NCT02148640

The NOR-SWITCH Study

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Innovator infliximab

Drug

Other names: Remicade

Biosimilar Infliximab

Drug

Other names: Remsima

Primary outcomes

  1. Occurrence of disease worsening

    Time frame: 52 weeks

    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.

Secondary outcomes

  1. Time to disease worsening

    Time frame: 52 weeks

  2. Occurrence of study drug discontinuation

    Time frame: 52 weeks

  3. Time to study drug discontinuation

    Time frame: 52 weeks

  4. Patient's global assessment of disease activity

    Time frame: 52 weeks

  5. Physicians's global assessment of disease activity

    Time frame: 52 weeks

  6. Inflammation laboratory parameters

    Time frame: 52 weeks

    ESR and CRP for all patients, Calprotectin for UC and CD patients

  7. Remission status according to DAS28

    Time frame: 52 weeks

    For RA and PsA patients

  8. Disease activity according to DAS28

    Time frame: 52 weeks

    For RA and PsA patients

  9. Remission status according to CDAI

    Time frame: 52 weeks

    For RA and PsA patients

  10. Disease activity according to CDAI

    Time frame: 52 weeks

    For RA and PsA patients

  11. Remission status according to SDAI

    Time frame: 52 weeks

    For RA and PsA patients

  12. Disease activity according to SDAI

    Time frame: 52 weeks

    For RA and PsA patients

  13. Remission status according to ACR/EULAR

    Time frame: 52 weeks

    For RA and PsA patients

  14. Disease activity according to ACR/EULAR

    Time frame: 52 weeks

    For RA and PsA patients

  15. Remission status according to ASDAS

    Time frame: 52 weeks

    For SpA patients

  16. Disease activity according to ASDAS

    Time frame: 52 weeks

    For SpA patients

  17. Remission status according to Partial Mayo Score

    Time frame: 52 weeks

    For UC patients

  18. Disease activity according to Partial Mayo Score

    Time frame: 52 weeks

    For UC patients

  19. Remission status according to Harvey-Bradshaw index

    Time frame: 52 weeks

    For CD patients

  20. Disease activity according to Harvey-Bradshaw index

    Time frame: 52 weeks

    For CD patients

  21. Remission status according to PASI

    Time frame: 52 weeks

    For psoriatic patients

  22. Disease activity according to PASI

    Time frame: 52 weeks

    For psoriatic patients

Other outcomes

  1. RAND SF-36

    Time frame: 52 weeks

  2. Modified Health Assessment Questionnaire (MHAQ)

    Time frame: 52 weeks

    Only RA, SpA and PsA patients

  3. Inflammatory Bowel Disease Questionnaire (IBDQ)

    Time frame: 52 weeks

    Only UC and CD patients

  4. Dermatology Life Quality Index (DLQI)

    Time frame: 52 weeks

    Only Ps patients

  5. EQ-5D

    Time frame: 52 weeks

  6. RAID

    Time frame: 52 weeks

    Only RA patients

  7. PsAID

    Time frame: 52 weeks

    Only PsA patients

  8. WPAI:GH

    Time frame: 52 weeks

    Work Productivity and Activity Impairment Questionnaire: General health

  9. Safety and tolerability: AEs, laboratory parameters

    Time frame: through study completion, an average of 52 weeks

Sponsors and collaborators

Lead sponsor

Diakonhjemmet Hospital

Other

Collaborators

  • South-Eastern Norway Regional Health Authority

Registry information

Official study title

A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN'S DISEASE AND CHRONIC PLAQUE PSORIASIS THE NOR-SWITCH STUDY

Acronym: NOR-SWITCH

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
May 28, 2014
Registry last updated
Sep 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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