Sub-cutaneous Infliximab in Inflammatory Rheumatic Disease (SIC2)

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

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis; Psoriatic Arthritis; Spondyloarthritis
• Intervention / Treatment: Other: collection of clinical parameters and blood sample

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®.

• Study Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• France
  • IDF
    • Paris, IDF, France, 75014
      • Rheumatology Department, Cochin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients who have agreed to receive SubCutaneous (SC) REMSIMA® and who continued this treatment for at least 6 months.	Therapeutic maintenance of SC REMSIMA® at 6 months, defined by the percentage of patients who have agreed to receive SC REMSIMA® and who continued this treatment for at least 6 months.	Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients switching or not switching to remsima® SC	Percentage of patients switching or not switching to remsima® sc (refusal, need to maintain iv, etc.) with the analysis of the reasons of non-switching	Day 0
Number of patients who requested to be re-established on intravenous(IV) infliximab	Number of patients who requested to be re-established on iv infliximab	Month 3
Number of patients who requested to be re-established on iv infliximab	Number of patients who requested to be re-established on iv infliximab	Month 6
Number of patients who requested to be re-established on iv infliximab	Number of patients who requested to be re-established on iv infliximab	Month 12
Number of sc remsima® discontinuation	Number of sc remsima® discontinuation	Month 3
Questionnaire about reasons explaining Remsina discontinuation	Reasons of sc remsima® discontinuation	Month 3
Number of sc remsima® discontinuation	Number of sc remsima® discontinuation	Month 6
Questionnaire about reasons explaining Remsina discontinuation	Reasons of sc remsima® discontinuation	Month 6
Number of sc remsima® discontinuation	Number of sc remsima® discontinuation	Month 12
Questionnaire about reasons explaining Remsina discontinuation	Reasons of sc remsima® discontinuation	Month 12
Number of missing SC injections	Number of missing SC injections	Month 3
Questionnaire about reasons explaining the missing of a scheduled Remsina injection	Reasons of missing SC injections	Month 3
Number of missing SC injections	Number of missing SC injections	Month 6
Questionnaire about reasons explaining the missing of a scheduled Remsina injection	Reasons of missing SC injections	Month 6
Number of missing SC injections	Number of missing SC injections	Month 12
Questionnaire about reasons explaining the missing of a scheduled Remsina injection	Reasons of missing SC injections	Month 12
Frequencies of serious adverse effects	Safety profile of sc remsima®	Month 3
Frequencies of serious adverse effects	Safety profile of sc remsima®	Month 6
Frequencies of serious adverse effects	Safety profile of sc remsima®	Month 12
Percentage of positive ADA	Immunogenicity profile of sc remsima®, consisting on the percentage of positive ADA at 6 months	Month 6
Percentage of positive ADA	Immunogenicity profile of sc remsima®, consisting on the percentage of positive ADA at 12 months	Month 12
Infliximab trough levels	Immunogenicity profile of sc remsima®, consisting on the course of infliximab trough levels between the inclusion visit and the 6 months visit	Month 6
Infliximab trough levels	Immunogenicity profile of sc remsima®, consisting on the course of infliximab trough levels between the inclusion visit and the 12 months visit.	Month 12
Presence or absence of inflammatory flare since the last infusion	Parameter measuring disease activity between the inclusion visit and the 3 months visit	Month 3
Presence or absence of inflammatory flare since the last infusion	Parameter measuring disease activity between the inclusion visit and the 6 months visit	Month 6
Presence or absence of inflammatory flare since the last infusion	Parameter measuring disease activity between the inclusion visit and the 12 months visit	Month 12
Number of flares of disease	Parameter measuring disease activity between the inclusion visit and the 3 months visit	Month 3
Number of flares of disease	Parameter measuring disease activity between the inclusion visit and the 6 months visit	Month 6
Number of flares of disease	Parameter measuring disease activity between the inclusion visit and the 12 months visit	Month 12
Scale of global appreciation of the activity (by the patient)	Scale of global appreciation of the activity (patient) : 0 to 100 (0 = lowest activity, 100 = highest activity) Parameter measuring disease activity between the inclusion visit and the 3 months visit	Month 3
Scale of global appreciation of the activity (by the patient)	Scale of global appreciation of the activity (patient) : 0 to 100 (0 = lowest activity, 100 = highest activity) Parameter measuring disease activity between the inclusion visit and the 6 months visit	Month 6
Scale of global appreciation of the activity (by the patient)	Scale of global appreciation of the activity (patient) : 0 to 100 (0 = lowest activity, 100 = highest activity) Parameter measuring disease activity between the inclusion visit and the 12 months visit	Month 12
Scale of global appreciation of the activity (by the investigator)	Scale of global appreciation of the activity (by the investigator) : 0 to 100 (0 = lowest activity, 100 = highest activity) Parameter measuring disease activity between the inclusion visit and the 3 months visit	Month 3
Scale of global appreciation of the activity (by the investigator)	Scale of global appreciation of the activity (by the investigator) : 0 to 100 (0 = lowest activity, 100 = highest activity) Parameter measuring disease activity between the inclusion visit and the 6 months visit	Month 6
Scale of global appreciation of the activity (by the investigator)	Scale of global appreciation of the activity (by the investigator) : 0 to 100 (0 = lowest activity, 100 = highest activity) Parameter measuring disease activity between the inclusion visit and the 12 months visit	Month 12
Number of swollen/painful joints (Rheumatoid arthritis patient)	Parameter measuring disease activity between the inclusion visit and the 3 months visit	Month 3
Number of swollen/painful joints (Rheumatoid arthritis patient)	Parameter measuring disease activity between the inclusion visit and the 6 months visit	Month 6
Number of swollen/painful joints (Rheumatoid arthritis patient)	Parameter measuring disease activity between the inclusion visit and the 12 months visit	Month 12
Disease Activity Score DAS28 VS (Rheumatoid arthritis patient)	Parameter measuring disease activity between the inclusion visit and the 3 months visit (< 2.6 remission, 2.6-3.2 low activity, 3.2-5.1 moderate activity, >5.1 strong activity)	Month 3
Disease Activity Score DAS28 VS (Rheumatoid arthritis patient)	Parameter measuring disease activity between the inclusion visit and the 6 months visit (< 2.6 remission, 2.6-3.2 low activity, 3.2-5.1 moderate activity, >5.1 strong activity)	Month 6
Disease Activity Score DAS28 VS (Rheumatoid arthritis patient)	Parameter measuring disease activity between the inclusion visit and the 12 months visit (< 2.6 remission, 2.6-3.2 low activity, 3.2-5.1 moderate activity, >5.1 strong activity)	Month 12
Disease Activity Score DAS28 CRP (Rheumatoid arthritis patient)	Parameter measuring disease activity between the inclusion visit and the 3 months visit (< 2.6 remission, 2.6-3.2 low activity, 3.2-5.1 moderate activity, >5.1 strong activity)	Month 3
Disease Activity Score DAS28 CRP (Rheumatoid arthritis patient)	Parameter measuring disease activity between the inclusion visit and the 6 months visit (< 2.6 remission, 2.6-3.2 low activity, 3.2-5.1 moderate activity, >5.1 strong activity)	Month 6
Disease Activity Score DAS28 CRP (Rheumatoid arthritis patient)	Parameter measuring disease activity between the inclusion visit and the 12 months visit (< 2.6 remission, 2.6-3.2 low activity, 3.2-5.1 moderate activity, >5.1 strong activity)	Month 12
BASDAI : Bath Ankylosing Spondylitis Disease Activity Index (Ankylosing Spondylitis patient)	Score : 0 to 100 (0 = lowest activity, 100 = highest activity) Parameter measuring disease activity between the inclusion visit and the 3 months visit	Month 3
BASDAI : Bath Ankylosing Spondylitis Disease Activity Index (Ankylosing Spondylitis patient)	Score : 0 to 100 (0 = lowest activity, 100 = highest activity) Parameter measuring disease activity between the inclusion visit and the 6 months visit	Month 6
BASDAI : Bath Ankylosing Spondylitis Disease Activity Index (Ankylosing Spondylitis patient)	Score : 0 to 100 (0 = lowest activity, 100 = highest activity) Parameter measuring disease activity between the inclusion visit and the 12 months visit	Month 12
Ankylosing Spondylitis Disease Activity Score with CRP (ASDAS-CRP) (Ankylosing Spondylitis patient)	Parameter measuring disease activity between the inclusion visit and the 3 months visit (< 1.3 inactive disease, 1.3-2.1 low activity, 2.1-3.5: high activity, > 3.5 very high activity)	Month 3
Ankylosing Spondylitis Disease Activity Score with CRP (ASDAS-CRP) (Ankylosing Spondylitis patient)	Parameter measuring disease activity between the inclusion visit and the 6 months visit (< 1.3 inactive disease, 1.3-2.1 low activity, 2.1-3.5: high activity, > 3.5 very high activity)	Month 6
Ankylosing Spondylitis Disease Activity Score with CRP (ASDAS-CRP) (Ankylosing Spondylitis patient)	Parameter measuring disease activity between the inclusion visit and the 12 months visit (< 1.3 inactive disease, 1.3-2.1 low activity, 2.1-3.5: high activity, > 3.5 very high activity)	Month 12

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC-CIC Paris Descartes Necker Cochin
• Investigators: Principal Investigator: Yannick ALLANORE, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2023
• Primary Completion (Actual): December 14, 2023
• Study Completion (Actual): December 16, 2024

Study Registration Dates

• First Submitted: December 6, 2021
• First Submitted That Met QC Criteria: June 17, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Biosimilar; Chronic inflammatory diseases; Sub-cutaneous route
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spinal Diseases; Spondylarthropathies; Skin Diseases, Papulosquamous; Skin Diseases; Spondylitis; Psoriasis; Skin and Connective Tissue Diseases; Spondylarthritis; Arthritis, Rheumatoid; Arthritis, Psoriatic; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: APHP211217; 2021-A02060-41 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No