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The effect of switching treatment from innovator infliximab to infliximab biosimilar on efficacy, safety and immunogenicity in patients with rheumatoid arthritis, spondyloarthritis or psoriatic arthritis in daily clinical care


- candidate number22449
- NTR NumberNTR5279
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-jul-2015
- Secondary IDs2015-1867 NIET WMO Submitted to CCMO: not WMO liable
- Public TitleThe effect of switching treatment from innovator infliximab to infliximab biosimilar on efficacy, safety and immunogenicity in patients with rheumatoid arthritis, spondyloarthritis or psoriatic arthritis in daily clinical care
- Scientific TitleBIO-SWITCH study: Biosimilar of Infliximab Options, Strengths and Weaknesses of Infliximab Treatment CHange
- ACRONYMBIO-SWITCH
- hypothesisTo explore the effect of switching treatment from innovator infliximab (Remicade®) to infliximab biosimilar (Inflectra®, Remsima®) on efficacy, safety and immunogenicity in patients with rheumatoid arthritis (RA), spondyloarthritis (SpA) or psoriatic arthritis (PsA) in daily clinical care
- Healt Condition(s) or Problem(s) studiedRheumatic diseases
- Inclusion criteria1. A clinical diagnosis of either RA, SpA or PsA.
2. Currently being treated with Remicade (1 or more infusions)
3. > 18 years of age
4. Ability to read and communicate well in Dutch
5. Informed consent
- Exclusion criteriaNone
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 14-jul-2015
- planned closingdate30-apr-2017
- Target number of participants200
- InterventionsBased on the treatment protocol of the hospitals, RA, SpA and PsA patients who are currently treated with Remicade will be informed about the option to switch to infliximab biosimilar. Both patients who will switch treatment to infliximab biosimilar (switch group) as patients who will not switch treatment (control group) will be asked to participate in this study. Data will be collected during the outpatient clinical visits performed in usual care during a 12 months follow-up. At baseline (day of the first infusion), patient characteristics and blood samples will be obtained. After 6 and 12 months (+/- 2 months) follow-up data on efficacy will be collected. Safety will be evaluated on the day of each infusion. After 6 and 12 months follow-up (+/- 2 months) a blood sample will be obtained on a scheduled infusion day.
- Primary outcomeThe difference in mean DAS28-ESR and mean DAS28-CRP (for RA and PsA) and mean BASDAI (for SpA) between baseline and follow-up (after 6 and 12 months of treatment with the biosimilar) will be used as primary efficacy endpoint
- Secondary outcome- To compare efficacy (difference in number of patients with low disease activity; DAS28-ESR ¡Ü 3.2 and DAS28-CRP ¡Ü 2.9 in RA and PsA, BASDAI < 4 in SpA) between baseline and after 6 and 12 months of treatment.
- To evaluate the cumulative incidence of RA and PsA patients with a flare at 6 and 12 months follow-up, defined as DAS28-CRP increase > 1.2 or DAS28-CRP increase > 0.6 and current DAS28-CRP ¡İ 3.2, compared to baseline DAS28-CRP.
- To evaluate the cumulative incidence of SpA patients with a flare at 6 and 12 months follow-up, defined as BASDAI increase > 2 or BASDAI increase > 1 and current BASDAI ¡İ 4, compared to baseline BASDAI. - To evaluate safety (adverse events (AEs) and serious adverse events (SAEs)) during the follow-up period. - To compare immunogenicity (% trough level anti-infliximab antibody positive patients) between baseline and after 6 and 12 months of follow-up.
- If a considerable number of patients will not switch treatment to infliximab biosimilar, the efficacy, safety and immunogenicity profile of the switch group will also be compared with that of the control group.
- TimepointsData will be recorded at baseline and after 6 and 12 months (+/- 2 months) of treatment.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. L. Tweehuysen
- CONTACT for SCIENTIFIC QUERIESDr. A.A. Broeder, den
- Sponsor/Initiator Sint Maartenskliniek Nijmegen, Maartenskliniek Woerden, Radboud University Medical Center Nijmegen, Rijnstate Ziekenhuis
- Funding
(Source(s) of Monetary or Material Support)
Sint Maartenskliniek Nijmegen, Maartenskliniek Woerden, Radboud University Medical Centre Nijmegen, Rijnstate Hospital
- PublicationsN/A
- Brief summaryBackground: Taking into account the overall data from the PLANETRA and PLANETAS study, previous positive experiences with switching to a biosimilar, the viewpoint of relevant (inter)national stakeholders and the large cost difference, switching from Remicade to infliximab biosimilar in RA, SpA and PsA patients might be a sensible option. This should be done in shared decision making with the patient and should be monitored with caution. It is expected that in 2015 a substantial number of patients will switch from Remicade to infliximab biosimilar in daily clinical care. Since regulatory guidelines recommend close monitoring of patients who switch treatment to a biosimilar, we shall collect data on efficacy, safety and immunogenicity in daily clinical care. Objective: To explore the effect of switching treatment from innovator infliximab (Remicade®) to infliximab biosimilar (Inflectra®, Remsima®) on efficacy, safety and immunogenicity in patients with RA, SpA or PsA in daily clinical care.
Study design: This is an exploratory observational controlled before after multicentre prospective cohort study.
Methods: Based on the treatment protocol of the hospitals, RA, SpA and PsA patients who are currently treated with Remicade will be informed about the option to switch to infliximab biosimilar. Both patients who will switch treatment to infliximab biosimilar (switch group) as patients who will not switch treatment (control group) will be asked to participate in this study. Data will be collected during the outpatient clinical visits performed in usual care during a 12 months follow-up. At baseline (day of the first infusion), patient characteristics and blood samples will be obtained. After 6 and 12 months (+/- 2 months) follow-up data on efficacy will be collected. Safety will be evaluated on the day of each infusion. After 6 and 12 months follow-up (+/- 2 months) a blood sample will be obtained on a scheduled infusion day.
- Main changes (audit trail)
- RECORD13-jul-2015 - 19-aug-2015


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