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The NOR-SWITCH Study (NOR-SWITCH)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02148640
First Posted: May 28, 2014
Last Update Posted: September 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
South-Eastern Norway Regional Health Authority
Information provided by (Responsible Party):
Tore K Kvien, Diakonhjemmet Hospital
  Purpose
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

Condition Intervention Phase
Rheumatoid Arthritis Spondyloarthritis Psoriatic Arthritis Ulcerative Colitis Crohn's Disease Psoriasis Chronic Drug: Innovator infliximab Drug: Biosimilar infliximab Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Tore K Kvien, Diakonhjemmet Hospital:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Time to disease worsening [ Time Frame: 52 weeks ]
  • Occurrence of study drug discontinuation [ Time Frame: 52 weeks ]
  • Time to study drug discontinuation [ Time Frame: 52 weeks ]
  • Patient's global assessment of disease activity [ Time Frame: 52 weeks ]
  • Physicians's global assessment of disease activity [ Time Frame: 52 weeks ]
  • Inflammation laboratory parameters [ Time Frame: 52 weeks ]
    ESR and CRP for all patients, Calprotectin for UC and CD patients

  • Remission status according to DAS28 [ Time Frame: 52 weeks ]
    For RA and PsA patients

  • Disease activity according to DAS28 [ Time Frame: 52 weeks ]
    For RA and PsA patients

  • Remission status according to CDAI [ Time Frame: 52 weeks ]
    For RA and PsA patients

  • Disease activity according to CDAI [ Time Frame: 52 weeks ]
    For RA and PsA patients

  • Remission status according to SDAI [ Time Frame: 52 weeks ]
    For RA and PsA patients

  • Disease activity according to SDAI [ Time Frame: 52 weeks ]
    For RA and PsA patients

  • Remission status according to ACR/EULAR [ Time Frame: 52 weeks ]
    For RA and PsA patients

  • Disease activity according to ACR/EULAR [ Time Frame: 52 weeks ]
    For RA and PsA patients

  • Remission status according to ASDAS [ Time Frame: 52 weeks ]
    For SpA patients

  • Disease activity according to ASDAS [ Time Frame: 52 weeks ]
    For SpA patients

  • Remission status according to Partial Mayo Score [ Time Frame: 52 weeks ]
    For UC patients

  • Disease activity according to Partial Mayo Score [ Time Frame: 52 weeks ]
    For UC patients

  • Remission status according to Harvey-Bradshaw index [ Time Frame: 52 weeks ]
    For CD patients

  • Disease activity according to Harvey-Bradshaw index [ Time Frame: 52 weeks ]
    For CD patients

  • Remission status according to PASI [ Time Frame: 52 weeks ]
    For psoriatic patients

  • Disease activity according to PASI [ Time Frame: 52 weeks ]
    For psoriatic patients


Other Outcome Measures:
  • RAND SF-36 [ Time Frame: 52 weeks ]
  • Modified Health Assessment Questionnaire (MHAQ) [ Time Frame: 52 weeks ]
    Only RA, SpA and PsA patients

  • Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: 52 weeks ]
    Only UC and CD patients

  • Dermatology Life Quality Index (DLQI) [ Time Frame: 52 weeks ]
    Only Ps patients

  • EQ-5D [ Time Frame: 52 weeks ]
  • RAID [ Time Frame: 52 weeks ]
    Only RA patients

  • PsAID [ Time Frame: 52 weeks ]
    Only PsA patients

  • WPAI:GH [ Time Frame: 52 weeks ]
    Work Productivity and Activity Impairment Questionnaire: General health

  • Safety and tolerability: AEs, laboratory parameters [ Time Frame: through study completion, an average of 52 weeks ]

Enrollment: 482
Study Start Date: October 2014
Study Completion Date: January 2017
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CT-P13
Infusions of biosimilar infliximab (Remsima) with same dose and frequency as pre-inclusion treatment with innovator infliximab (Remicade)
Drug: Biosimilar infliximab
Other Name: Remsima
Active Comparator: INX
Continued infusions of innovator infliximab (Remicade) with same dose and frequency as prior to inclusion
Drug: Innovator infliximab
Other Name: Remicade

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. A clinical diagnosis of either rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, 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 Criteria:

  1. 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
  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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02148640


Locations
Norway
Sørlandet Sykehus HF
Arendal, 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, 0319
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
Ålesund Sjukehus, Helse Møre og Romsdal HF
Ålesund, Norway
Sponsors and Collaborators
Diakonhjemmet Hospital
South-Eastern Norway Regional Health Authority
Investigators
Principal Investigator: Tore K. Kvien, MD PhD Diakonhjemmet Hospital
  More Information

Responsible Party: Tore K Kvien, Prof. Dr. Med., Diakonhjemmet Hospital
ClinicalTrials.gov Identifier: NCT02148640     History of Changes
Other Study ID Numbers: DIA2014-01
2014-002056-40 ( EudraCT Number )
First Submitted: May 23, 2014
First Posted: May 28, 2014
Last Update Posted: September 25, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Psoriasis
Crohn Disease
Colitis
Ulcer
Colitis, Ulcerative
Arthritis, Psoriatic
Spondylarthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases
Pathologic Processes
Spondylarthropathies
Spondylitis
Spinal Diseases
Bone Diseases
Infliximab
Dermatologic Agents