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Rheumatoid ArthritisPhase 4NOR-SWITCHNCT02148640

The NOR-SWITCH Study

A Phase 4 study testing Innovator infliximab and Biosimilar infliximab in people with Rheumatoid Arthritis and Spondyloarthritis, run by Diakonhjemmet Hospital at 30 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Innovator infliximab and Biosimilar infliximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
482 participants
Where
30 sitesNorway
Study dates
Oct 2014to Jan 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

Norway30 sites

  • Ålesund Sjukehus, Helse Møre og Romsdal HF

    Ålesund

  • Sørlandet Sykehus HF

    Arendal

  • Haukeland Universitetssjukehus Hf

    Bergen

  • Haukeland Universitetssykehus

    Bergen

  • Nordlandssykehuset

    Bodø

  • Sykehuset Innlandet

    Elverum

  • Helse Førde Hf

    Førde

  • Sykehuset Østfold HF

    Fredrikstad

  • Bærum Sykehus

    Gjettum

  • Sykehuset Innlandet

    Gjøvik

  • Sykehuset Innlandet

    Hamar

  • Haugesund Sanitetsforenings Revmatismesykehus

    Haugesund

  • Helse Fonna HF

    Haugesund

  • Sørlandet Sykehus HF

    Kristiansand

  • Helse Nord-Trøndelag

    Levanger

  • Revmatismesykehuset Lillehammer

    Lillehammer

  • Sykehuset Innlandet

    Lillehammer

  • Akershus Universitetssykehus

    Lørenskog

  • Helgelandssykehuset

    Mo i Rana

  • Department of Rheumatology, Diakonhjemmet Hospital

    Oslo, 0319

  • Diakonhjemmet Hospital

    Oslo

  • Oslo Universitetssykehus, Rikshospitalet

    Oslo

  • Oslo Universitetssykehus, Ullevål

    Oslo

  • Martina Hansens Hospital

    Sandvika

  • Betanien Hospital

    Skien

  • Sykehuset Telemark HF

    Skien

  • Sykehuset Vestfold

    Tønsberg

  • Universitetssykehuset i Nord-Norge

    Tromsø

  • St. Olavs Hospital HF

    Trondheim

  • St. Olavs Hospital

    Trondheim

Other trials in Norway

About this study

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

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

Being tested
Innovator infliximab, Biosimilar infliximab
Medical subject headings
Arthritis, Rheumatoid, Spondylarthritis, Arthritis, Psoriatic, Colitis, Ulcerative, Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Innovator infliximabDrug

    Also called Remicade

  • Biosimilar infliximabDrug

    Also called Remsima

Study groups in NCT02148640
Study groupRoleWhat they receive
CT-P13ExperimentalInfusions of biosimilar infliximab (Remsima) with same dose and frequency as pre-inclusion treatment with innovator infliximab (Remicade)
Receives: Drug: Biosimilar infliximab
INXActive comparatorContinued infusions of innovator infliximab (Remicade) with same dose and frequency as prior to inclusion
Receives: Drug: Innovator infliximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 52 weeks

Secondary outcomes (22)

  1. Time to disease worsening

    Measured: 52 weeks

  2. Occurrence of study drug discontinuation

    Measured: 52 weeks

  3. Time to study drug discontinuation

    Measured: 52 weeks

  4. Patient's global assessment of disease activity

    Measured: 52 weeks

  5. Physicians's global assessment of disease activity

    Measured: 52 weeks

  6. Inflammation laboratory parameters

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

    Measured: 52 weeks

  7. Remission status according to DAS28

    For RA and PsA patients

    Measured: 52 weeks

  8. Disease activity according to DAS28

    For RA and PsA patients

    Measured: 52 weeks

  9. Remission status according to CDAI

    For RA and PsA patients

    Measured: 52 weeks

  10. Disease activity according to CDAI

    For RA and PsA patients

    Measured: 52 weeks

  11. Remission status according to SDAI

    For RA and PsA patients

    Measured: 52 weeks

  12. Disease activity according to SDAI

    For RA and PsA patients

    Measured: 52 weeks

  13. Remission status according to ACR/EULAR

    For RA and PsA patients

    Measured: 52 weeks

  14. Disease activity according to ACR/EULAR

    For RA and PsA patients

    Measured: 52 weeks

  15. Remission status according to ASDAS

    For SpA patients

    Measured: 52 weeks

  16. Disease activity according to ASDAS

    For SpA patients

    Measured: 52 weeks

  17. Remission status according to Partial Mayo Score

    For UC patients

    Measured: 52 weeks

  18. Disease activity according to Partial Mayo Score

    For UC patients

    Measured: 52 weeks

  19. Remission status according to Harvey-Bradshaw index

    For CD patients

    Measured: 52 weeks

  20. Disease activity according to Harvey-Bradshaw index

    For CD patients

    Measured: 52 weeks

  21. Remission status according to PASI

    For psoriatic patients

    Measured: 52 weeks

  22. Disease activity according to PASI

    For psoriatic patients

    Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionJun 2016
  4. Study completionJan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
482 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02148640
Sponsor's protocol ID
DIA2014-01
Other IDs
2014-002056-40, 2014
Acronym
NOR-SWITCH
Status last verified
Sep 2017
First submitted
23 May 2014
Last updated
25 Sep 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 32965617

  • 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.

    PubMed 30762274

  • 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.

    PubMed 28502609

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Innovator infliximab and Biosimilar infliximab in people with Rheumatoid Arthritis and Spondyloarthritis, run by Diakonhjemmet Hospital at 30 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of disease worsening (time frame: 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02148640, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2017.

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