Sub-cutaneous Infliximab in Inflammatory Rheumatic Disease

NCT ID: NCT05424926

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 22 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-24
• Study Completion Date: 2024-12-16

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients

Patients

collection of clinical parameters and blood sample

Intervention Type: OTHER

• 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).

Interventions

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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients aged 18 or older
• Patients who has received at least 3 IV infliximab infusions and suffer from chronic inflammatory rheumatic condition
• Absence of disease flare / progressive disease preventing the continuation of infliximab
• Patient affiliated to national insurance

Exclusion Criteria

• Any patient whose doctor considers that he will not be able to comply with the obligations of the trial
• Patients under curatorship or tutorship
• Pregnant women

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yannick ALLANORE, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Rheumatology Department, Cochin Hospital

Paris, IDF, France

Countries

France

Other Identifiers

2021-A02060-41

Identifier Type: OTHER

Identifier Source: secondary_id

APHP211217

Identifier Type: -

Identifier Source: org_study_id