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

BIO-SWITCH study: Biosimilar of Infliximab Options, Strengths and Weaknesses of Infliximab Treatment CHange

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON24401

Enrollment

200

Registered

2015-07-13

Start date

2015-07-14

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biosimilar, Infliximab, Inflectra, Remsima

Interventions

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 w

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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 criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
The 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

Measure	Time frame
- 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 1.2 or DAS28-CRP increase > 0.6 and current DAS28-CRP ¡Ý 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 ¡Ý 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.	—

Measure

Time frame

- 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 1.2 or DAS28-CRP increase > 0.6 and current DAS28-CRP ¡Ý 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 ¡Ý 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.

—

Contacts

Public ContactAlfons den Broeder

Sint Maartenskliniek

a.denbroeder@maartenskliniek.nl+31243659276

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)