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The NOR-SWITCH Study (NOR-SWITCH)

Primary Purpose

Rheumatoid Arthritis, Spondyloarthritis, Psoriatic Arthritis

Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Innovator infliximab
Biosimilar infliximab
Sponsored by
Diakonhjemmet Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sørlandet Sykehus HF
  • Haukeland Universitetssjukehus Hf
  • Haukeland Universitetssykehus
  • Nordlandssykehuset
  • Sykehuset Innlandet
  • Sykehuset Østfold HF
  • Helse Førde Hf
  • Bærum Sykehus
  • Sykehuset Innlandet
  • Sykehuset Innlandet
  • Haugesund Sanitetsforenings Revmatismesykehus
  • Helse Fonna HF
  • Sørlandet Sykehus HF
  • Helse Nord-Trøndelag
  • Revmatismesykehuset Lillehammer
  • Sykehuset Innlandet
  • Akershus Universitetssykehus
  • Helgelandssykehuset
  • Department of Rheumatology, Diakonhjemmet Hospital
  • Diakonhjemmet Hospital
  • Oslo Universitetssykehus, Rikshospitalet
  • Oslo Universitetssykehus, Ullevål
  • Martina Hansens Hospital
  • Betanien Hospital
  • Sykehuset Telemark HF
  • Universitetssykehuset i Nord-Norge
  • St. Olavs Hospital HF
  • St. Olavs Hospital
  • Sykehuset Vestfold
  • Ålesund Sjukehus, Helse Møre og Romsdal HF

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CT-P13

INX

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time to disease worsening
Occurrence of study drug discontinuation
Time to study drug discontinuation
Patient's global assessment of disease activity
Physicians's global assessment of disease activity
Inflammation laboratory parameters
ESR and CRP for all patients, Calprotectin for UC and CD patients
Remission status according to DAS28
For RA and PsA patients
Disease activity according to DAS28
For RA and PsA patients
Remission status according to CDAI
For RA and PsA patients
Disease activity according to CDAI
For RA and PsA patients
Remission status according to SDAI
For RA and PsA patients
Disease activity according to SDAI
For RA and PsA patients
Remission status according to ACR/EULAR
For RA and PsA patients
Disease activity according to ACR/EULAR
For RA and PsA patients
Remission status according to ASDAS
For SpA patients
Disease activity according to ASDAS
For SpA patients
Remission status according to Partial Mayo Score
For UC patients
Disease activity according to Partial Mayo Score
For UC patients
Remission status according to Harvey-Bradshaw index
For CD patients
Disease activity according to Harvey-Bradshaw index
For CD patients
Remission status according to PASI
For psoriatic patients
Disease activity according to PASI
For psoriatic patients

Full Information

First Posted
May 23, 2014
Last Updated
September 22, 2017
Sponsor
Diakonhjemmet Hospital
Collaborators
South-Eastern Norway Regional Health Authority
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1. Study Identification

Unique Protocol Identification Number
NCT02148640
Brief Title
The NOR-SWITCH Study
Acronym
NOR-SWITCH
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diakonhjemmet Hospital
Collaborators
South-Eastern Norway Regional Health Authority

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Spondyloarthritis, Psoriatic Arthritis, Ulcerative Colitis, Crohn's Disease, Psoriasis Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
482 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CT-P13
Arm Type
Experimental
Arm Description
Infusions of biosimilar infliximab (Remsima) with same dose and frequency as pre-inclusion treatment with innovator infliximab (Remicade)
Arm Title
INX
Arm Type
Active Comparator
Arm Description
Continued infusions of innovator infliximab (Remicade) with same dose and frequency as prior to inclusion
Intervention Type
Drug
Intervention Name(s)
Innovator infliximab
Other Intervention Name(s)
Remicade
Intervention Type
Drug
Intervention Name(s)
Biosimilar infliximab
Other Intervention Name(s)
Remsima
Primary Outcome Measure Information:
Title
Occurrence of disease worsening
Description
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.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Time to disease worsening
Time Frame
52 weeks
Title
Occurrence of study drug discontinuation
Time Frame
52 weeks
Title
Time to study drug discontinuation
Time Frame
52 weeks
Title
Patient's global assessment of disease activity
Time Frame
52 weeks
Title
Physicians's global assessment of disease activity
Time Frame
52 weeks
Title
Inflammation laboratory parameters
Description
ESR and CRP for all patients, Calprotectin for UC and CD patients
Time Frame
52 weeks
Title
Remission status according to DAS28
Description
For RA and PsA patients
Time Frame
52 weeks
Title
Disease activity according to DAS28
Description
For RA and PsA patients
Time Frame
52 weeks
Title
Remission status according to CDAI
Description
For RA and PsA patients
Time Frame
52 weeks
Title
Disease activity according to CDAI
Description
For RA and PsA patients
Time Frame
52 weeks
Title
Remission status according to SDAI
Description
For RA and PsA patients
Time Frame
52 weeks
Title
Disease activity according to SDAI
Description
For RA and PsA patients
Time Frame
52 weeks
Title
Remission status according to ACR/EULAR
Description
For RA and PsA patients
Time Frame
52 weeks
Title
Disease activity according to ACR/EULAR
Description
For RA and PsA patients
Time Frame
52 weeks
Title
Remission status according to ASDAS
Description
For SpA patients
Time Frame
52 weeks
Title
Disease activity according to ASDAS
Description
For SpA patients
Time Frame
52 weeks
Title
Remission status according to Partial Mayo Score
Description
For UC patients
Time Frame
52 weeks
Title
Disease activity according to Partial Mayo Score
Description
For UC patients
Time Frame
52 weeks
Title
Remission status according to Harvey-Bradshaw index
Description
For CD patients
Time Frame
52 weeks
Title
Disease activity according to Harvey-Bradshaw index
Description
For CD patients
Time Frame
52 weeks
Title
Remission status according to PASI
Description
For psoriatic patients
Time Frame
52 weeks
Title
Disease activity according to PASI
Description
For psoriatic patients
Time Frame
52 weeks
Other Pre-specified Outcome Measures:
Title
RAND SF-36
Time Frame
52 weeks
Title
Modified Health Assessment Questionnaire (MHAQ)
Description
Only RA, SpA and PsA patients
Time Frame
52 weeks
Title
Inflammatory Bowel Disease Questionnaire (IBDQ)
Description
Only UC and CD patients
Time Frame
52 weeks
Title
Dermatology Life Quality Index (DLQI)
Description
Only Ps patients
Time Frame
52 weeks
Title
EQ-5D
Time Frame
52 weeks
Title
RAID
Description
Only RA patients
Time Frame
52 weeks
Title
PsAID
Description
Only PsA patients
Time Frame
52 weeks
Title
WPAI:GH
Description
Work Productivity and Activity Impairment Questionnaire: General health
Time Frame
52 weeks
Title
Safety and tolerability: AEs, laboratory parameters
Time Frame
through study completion, an average of 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tore K. Kvien, MD PhD
Organizational Affiliation
Diakonhjemmet Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sørlandet Sykehus HF
City
Arendal
Country
Norway
Facility Name
Haukeland Universitetssjukehus Hf
City
Bergen
Country
Norway
Facility Name
Haukeland Universitetssykehus
City
Bergen
Country
Norway
Facility Name
Nordlandssykehuset
City
Bodø
Country
Norway
Facility Name
Sykehuset Innlandet
City
Elverum
Country
Norway
Facility Name
Sykehuset Østfold HF
City
Fredrikstad
Country
Norway
Facility Name
Helse Førde Hf
City
Førde
Country
Norway
Facility Name
Bærum Sykehus
City
Gjettum
Country
Norway
Facility Name
Sykehuset Innlandet
City
Gjøvik
Country
Norway
Facility Name
Sykehuset Innlandet
City
Hamar
Country
Norway
Facility Name
Haugesund Sanitetsforenings Revmatismesykehus
City
Haugesund
Country
Norway
Facility Name
Helse Fonna HF
City
Haugesund
Country
Norway
Facility Name
Sørlandet Sykehus HF
City
Kristiansand
Country
Norway
Facility Name
Helse Nord-Trøndelag
City
Levanger
Country
Norway
Facility Name
Revmatismesykehuset Lillehammer
City
Lillehammer
Country
Norway
Facility Name
Sykehuset Innlandet
City
Lillehammer
Country
Norway
Facility Name
Akershus Universitetssykehus
City
Lørenskog
Country
Norway
Facility Name
Helgelandssykehuset
City
Mo i Rana
Country
Norway
Facility Name
Department of Rheumatology, Diakonhjemmet Hospital
City
Oslo
ZIP/Postal Code
0319
Country
Norway
Facility Name
Diakonhjemmet Hospital
City
Oslo
Country
Norway
Facility Name
Oslo Universitetssykehus, Rikshospitalet
City
Oslo
Country
Norway
Facility Name
Oslo Universitetssykehus, Ullevål
City
Oslo
Country
Norway
Facility Name
Martina Hansens Hospital
City
Sandvika
Country
Norway
Facility Name
Betanien Hospital
City
Skien
Country
Norway
Facility Name
Sykehuset Telemark HF
City
Skien
Country
Norway
Facility Name
Universitetssykehuset i Nord-Norge
City
Tromsø
Country
Norway
Facility Name
St. Olavs Hospital HF
City
Trondheim
Country
Norway
Facility Name
St. Olavs Hospital
City
Trondheim
Country
Norway
Facility Name
Sykehuset Vestfold
City
Tønsberg
Country
Norway
Facility Name
Ålesund Sjukehus, Helse Møre og Romsdal HF
City
Ålesund
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
32965617
Citation
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.
Results Reference
derived
PubMed Identifier
30762274
Citation
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.
Results Reference
derived
PubMed Identifier
28502609
Citation
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. Erratum In: Lancet. 2017 Jun 10;389(10086):2286.
Results Reference
derived

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The NOR-SWITCH Study

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