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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
482
Sørlandet Sykehus HF
Arendal, Norway
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.
Time frame: 52 weeks
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
ESR and CRP for all patients, Calprotectin for UC and CD patients
Time frame: 52 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Ålesund Sjukehus, Helse Møre og Romsdal HF
Ålesund, 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
...and 20 more locations
Remission status according to DAS28
For RA and PsA patients
Time frame: 52 weeks
Disease activity according to DAS28
For RA and PsA patients
Time frame: 52 weeks
Remission status according to CDAI
For RA and PsA patients
Time frame: 52 weeks
Disease activity according to CDAI
For RA and PsA patients
Time frame: 52 weeks
Remission status according to SDAI
For RA and PsA patients
Time frame: 52 weeks
Disease activity according to SDAI
For RA and PsA patients
Time frame: 52 weeks
Remission status according to ACR/EULAR
For RA and PsA patients
Time frame: 52 weeks
Disease activity according to ACR/EULAR
For RA and PsA patients
Time frame: 52 weeks
Remission status according to ASDAS
For SpA patients
Time frame: 52 weeks
Disease activity according to ASDAS
For SpA patients
Time frame: 52 weeks
Remission status according to Partial Mayo Score
For UC patients
Time frame: 52 weeks
Disease activity according to Partial Mayo Score
For UC patients
Time frame: 52 weeks
Remission status according to Harvey-Bradshaw index
For CD patients
Time frame: 52 weeks
Disease activity according to Harvey-Bradshaw index
For CD patients
Time frame: 52 weeks
Remission status according to PASI
For psoriatic patients
Time frame: 52 weeks
Disease activity according to PASI
For psoriatic patients
Time frame: 52 weeks