Clinical trial NCT02148640: The NOR-SWITCH 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Spondyloarthritis
Psoriatic Arthritis
Ulcerative Colitis
Crohn's Disease
Psoriasis Chronic
Lead sponsor: Diakonhjemmet Hospital
Sponsor class: OTHER
Collaborators: name: South-Eastern Norway Regional Health Authority
First posted: 2014-05-28
Enrollment: 482
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Occurrence of disease worsening
timeFrame: 52 weeks
Secondary outcomes:
measure: Time to disease worsening
timeFrame: 52 weeks
measure: Occurrence of study drug discontinuation
timeFrame: 52 weeks
measure: Time to study drug discontinuation
timeFrame: 52 weeks
measure: Patient's global assessment of disease activity
timeFrame: 52 weeks
measure: Physicians's global assessment of disease activity
timeFrame: 52 weeks
measure: Inflammation laboratory parameters
timeFrame: 52 weeks
measure: Remission status according to DAS28
timeFrame: 52 weeks
measure: Disease activity according to DAS28
timeFrame: 52 weeks
measure: Remission status according to CDAI
timeFrame: 52 weeks
measure: Disease activity according to CDAI
timeFrame: 52 weeks
measure: Remission status according to SDAI
timeFrame: 52 weeks
measure: Disease activity according to SDAI
timeFrame: 52 weeks
measure: Remission status according to ACR/EULAR
timeFrame: 52 weeks
measure: Disease activity according to ACR/EULAR
timeFrame: 52 weeks
measure: Remission status according to ASDAS
timeFrame: 52 weeks
measure: Disease activity according to ASDAS
timeFrame: 52 weeks
measure: Remission status according to Partial Mayo Score
timeFrame: 52 weeks
measure: Disease activity according to Partial Mayo Score
timeFrame: 52 weeks
measure: Remission status according to Harvey-Bradshaw index
timeFrame: 52 weeks
measure: Disease activity according to Harvey-Bradshaw index
timeFrame: 52 weeks
measure: Remission status according to PASI
timeFrame: 52 weeks
measure: Disease activity according to PASI
timeFrame: 52 weeks
Other outcomes:
measure: RAND SF-36
timeFrame: 52 weeks
measure: Modified Health Assessment Questionnaire (MHAQ)
timeFrame: 52 weeks
measure: Inflammatory Bowel Disease Questionnaire (IBDQ)
timeFrame: 52 weeks
measure: Dermatology Life Quality Index (DLQI)
timeFrame: 52 weeks
measure: EQ-5D
timeFrame: 52 weeks
measure: RAID
timeFrame: 52 weeks
measure: PsAID
timeFrame: 52 weeks
measure: WPAI:GH
timeFrame: 52 weeks
measure: Safety and tolerability: AEs, laboratory parameters
timeFrame: through study completion, an average of 52 weeks
Locations:
city: Arendal
country: Norway
facility: Sørlandet Sykehus HF
city: Bergen
country: Norway
facility: Haukeland Universitetssjukehus Hf
city: Bergen
country: Norway
facility: Haukeland Universitetssykehus
city: Bodø
country: Norway
facility: Nordlandssykehuset
city: Elverum
country: Norway
facility: Sykehuset Innlandet
city: Fredrikstad
country: Norway
facility: Sykehuset Østfold HF
city: Førde
country: Norway
facility: Helse Førde Hf
city: Gjettum
country: Norway
facility: Bærum Sykehus
city: Gjøvik
country: Norway
facility: Sykehuset Innlandet
city: Hamar
country: Norway
facility: Sykehuset Innlandet
city: Haugesund
country: Norway
facility: Haugesund Sanitetsforenings Revmatismesykehus
city: Haugesund
country: Norway
facility: Helse Fonna HF
city: Kristiansand
country: Norway
facility: Sørlandet Sykehus HF
city: Levanger
country: Norway
facility: Helse Nord-Trøndelag
city: Lillehammer
country: Norway
facility: Revmatismesykehuset Lillehammer
city: Lillehammer
country: Norway
facility: Sykehuset Innlandet
city: Lørenskog
country: Norway
facility: Akershus Universitetssykehus
city: Mo i Rana
country: Norway
facility: Helgelandssykehuset
city: Oslo
country: Norway
facility: Department of Rheumatology, Diakonhjemmet Hospital
city: Oslo
country: Norway
facility: Diakonhjemmet Hospital
city: Oslo
country: Norway
facility: Oslo Universitetssykehus, Rikshospitalet
city: Oslo
country: Norway
facility: Oslo Universitetssykehus, Ullevål
city: Sandvika
country: Norway
facility: Martina Hansens Hospital
city: Skien
country: Norway
facility: Betanien Hospital
city: Skien
country: Norway
facility: Sykehuset Telemark HF
city: Tromsø
country: Norway
facility: Universitetssykehuset i Nord-Norge
city: Trondheim
country: Norway
facility: St. Olavs Hospital HF
city: Trondheim
country: Norway
facility: St. Olavs Hospital
city: Tønsberg
country: Norway
facility: Sykehuset Vestfold
city: Ålesund
country: Norway
facility: Ålesund Sjukehus, Helse Møre og Romsdal HF
Study officials:
affiliation: Diakonhjemmet Hospital
name: Tore K. Kvien, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.