Innovator infliximab
DrugOther names: Remicade
NCT Number: NCT02148640
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
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Sørlandet Sykehus HF, Arendal, Norway
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: Remicade
Other names: Remsima
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.
Time frame: 52 weeks
Time frame: 52 weeks
Time frame: 52 weeks
Time frame: 52 weeks
Time frame: 52 weeks
Time frame: 52 weeks
ESR and CRP for all patients, Calprotectin for UC and CD patients
Time frame: 52 weeks
For RA and PsA patients
Time frame: 52 weeks
For RA and PsA patients
Time frame: 52 weeks
For RA and PsA patients
Time frame: 52 weeks
For RA and PsA patients
Time frame: 52 weeks
For RA and PsA patients
Time frame: 52 weeks
For RA and PsA patients
Time frame: 52 weeks
For RA and PsA patients
Time frame: 52 weeks
For RA and PsA patients
Time frame: 52 weeks
For SpA patients
Time frame: 52 weeks
For SpA patients
Time frame: 52 weeks
For UC patients
Time frame: 52 weeks
For UC patients
Time frame: 52 weeks
For CD patients
Time frame: 52 weeks
For CD patients
Time frame: 52 weeks
For psoriatic patients
Time frame: 52 weeks
For psoriatic patients
Time frame: 52 weeks
Time frame: 52 weeks
Only RA, SpA and PsA patients
Time frame: 52 weeks
Only UC and CD patients
Time frame: 52 weeks
Only Ps patients
Time frame: 52 weeks
Time frame: 52 weeks
Only RA patients
Time frame: 52 weeks
Only PsA patients
Time frame: 52 weeks
Work Productivity and Activity Impairment Questionnaire: General health
Time frame: through study completion, an average of 52 weeks
Diakonhjemmet Hospital
Other
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
Acronym: NOR-SWITCH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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