NCT05424926

Sub-cutaneous Infliximab in Inflammatory Rheumatic Disease

Switch From Intravenous to Subcutaneous Infliximab (REMSIMA®) in Clinical Practice in the Rheumatology Department of Cochin Hospital

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 22 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

TNFα inhibitors have revolutionized the management of patients suffering from inflammatory diseases in the field of rheumatology. Infliximab remains widely used in France, and infliximab biosimilars have been routinely used since 2015 in Cochin Hospital with an interchangeability strategy validated by two real life studies. REMSIMA® 120 mg is the first authorized subcutaneous (SC) form of infliximab to be administered at a fixed dose of 120 mg every 2 weeks. Scarce information is available regarding the safety and efficacy of proposing a switch from IV infliximab to SC REMSIMA® in the subsets of patients suffering from different rheumatic diseases in daily care. The primary objective of the SIC2 study will be determine the retention rate of Remsima SC at 6 months. The investigators will recruit adult patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis.

Detailed description

TNFα inhibitors have revolutionized the management of patients suffering from inflammatory diseases in the field of rheumatology. Infliximab remains widely used in France, and infliximab biosimilars have been routinely used since 2015 in Cochin Hospital with an interchangeability strategy validated by two real life studies. REMSIMA® 120 mg is the first authorized subcutaneous (SC) form of infliximab to be administered at a fixed dose of 120 mg every 2 weeks. Scarce information is available regarding the safety and efficacy of proposing a switch from IV infliximab to SC REMSIMA® in the subsets of patients suffering from different rheumatic diseases in daily care. The primary objective of the SIC2 study will be determine the retention rate of Remsima SC at 6 months. The investigators will recruit adult patients with rheumatoid arthritis, spondyloarthritis, psoriatic arthritis. Main inclusion criteria will be patients who have received at least 3 IV infliximab infusions and suffer from chronic inflammatory rheumatic condition with the absence of disease flare / progressive disease preventing the continuation of infliximab. The primary endpoint will be the percentage of patients who have agreed to receive SC REMSIMA® and who continued this treatment for at least 3 months. Secondary objectives will be the reasons of switching or not to Remsima, the need for patients to be re-established on iv infliximab, SC Remsima® discontinuation and adherence, changes in disease activity between the inclusion visit and the last visit, the safety profile of sc remsima®, the immunogenicity profile of sc remsima®.

Conditions

• Rheumatoid Arthritis
• Spondyloarthritis
• Psoriatic Arthritis

Interventions

Type	Name	Description
OTHER	collection of clinical parameters and blood sample	* A baseline visit, with collection of clinical parameters and blood sample to measure anti-infliximab antibodies and infliximab trough levels. * Follow-up visits at 3 months (in outpatient clinic for clinical evaluation), 6 months and 12 months (in day hospitalization for clinical evaluation and blood sample collection for ADA detection and infliximab trough level measurement).

Timeline

• Start date: 2023-02-24
• Primary completion: 2023-12-14
• Completion: 2024-12-16
• First posted: 2022-06-21
• Last updated: 2026-04-08

Locations

1 site across 1 country: France