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The NOR-SWITCH Study (NOR-SWITCH)

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.
 
ClinicalTrials.gov Identifier: NCT02148640
Recruitment Status : Completed
First Posted : May 28, 2014
Last Update Posted : September 25, 2017
Sponsor:
Collaborator:
South-Eastern Norway Regional Health Authority
Information provided by (Responsible Party):
Tore K Kvien, Diakonhjemmet Hospital

Tracking Information
First Submitted Date  ICMJE May 23, 2014
First Posted Date  ICMJE May 28, 2014
Last Update Posted Date September 25, 2017
Study Start Date  ICMJE October 2014
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2016)
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: June 17, 2016)
  • 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 ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The NOR-SWITCH Study
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Rheumatoid Arthritis
  • Spondyloarthritis
  • Psoriatic Arthritis
  • Ulcerative Colitis
  • Crohn's Disease
  • Psoriasis Chronic
Intervention  ICMJE
  • Drug: Innovator infliximab
    Other Name: Remicade
  • Drug: Biosimilar infliximab
    Other Name: Remsima
Study Arms  ICMJE
  • Experimental: CT-P13
    Infusions of biosimilar infliximab (Remsima) with same dose and frequency as pre-inclusion treatment with innovator infliximab (Remicade)
    Intervention: Drug: Biosimilar infliximab
  • Active Comparator: INX
    Continued infusions of innovator infliximab (Remicade) with same dose and frequency as prior to inclusion
    Intervention: Drug: Innovator infliximab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 6, 2016)
482
Original Estimated Enrollment  ICMJE
 (submitted: May 27, 2014)
500
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02148640
Other Study ID Numbers  ICMJE DIA2014-01
2014-002056-40 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tore K Kvien, Diakonhjemmet Hospital
Study Sponsor  ICMJE Diakonhjemmet Hospital
Collaborators  ICMJE South-Eastern Norway Regional Health Authority
Investigators  ICMJE
Principal Investigator: Tore K. Kvien, MD PhD Diakonhjemmet Hospital
PRS Account Diakonhjemmet Hospital
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP