Sub-cutaneous Infliximab in Inflammatory Rheumatic Disease

Rheumatoid Arthritis Clinical Trial

— SIC2  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05424926
• Other study ID #: APHP211217
• Secondary ID: 2021-A02060-41
• Status: Active, not recruiting
• Start date: February 24, 2023
• Est. completion date: February 2025

Study information

• Verified date: March 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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®.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: February 2025
• Est. primary completion date: December 14, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis
• Rheumatoid Arthritis
• Spondylarthritis
• Spondylitis
• Spondyloarthritis

Intervention

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).

Locations

Country	Name	City	State
France	Rheumatology Department, Cochin Hospital	Paris	IDF

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of sc remsima® discontinuation	Number of sc remsima® discontinuation	Month 3
Secondary	Questionnaire about reasons explaining Remsina discontinuation	Reasons of sc remsima® discontinuation	Month 3
Secondary	Number of sc remsima® discontinuation	Number of sc remsima® discontinuation	Month 6
Secondary	Questionnaire about reasons explaining Remsina discontinuation	Reasons of sc remsima® discontinuation	Month 6
Secondary	Number of sc remsima® discontinuation	Number of sc remsima® discontinuation	Month 12
Secondary	Questionnaire about reasons explaining Remsina discontinuation	Reasons of sc remsima® discontinuation	Month 12
Secondary	Number of missing SC injections	Number of missing SC injections	Month 3
Secondary	Questionnaire about reasons explaining the missing of a scheduled Remsina injection	Reasons of missing SC injections	Month 3
Secondary	Number of missing SC injections	Number of missing SC injections	Month 6
Secondary	Questionnaire about reasons explaining the missing of a scheduled Remsina injection	Reasons of missing SC injections	Month 6
Secondary	Number of missing SC injections	Number of missing SC injections	Month 12
Secondary	Questionnaire about reasons explaining the missing of a scheduled Remsina injection	Reasons of missing SC injections	Month 12
Secondary	Frequencies of serious adverse effects	Safety profile of sc remsima®	Month 3
Secondary	Frequencies of serious adverse effects	Safety profile of sc remsima®	Month 6
Secondary	Frequencies of serious adverse effects	Safety profile of sc remsima®	Month 12
Secondary	Percentage of positive ADA	Immunogenicity profile of sc remsima®, consisting on the percentage of positive ADA at 6 months	Month 6
Secondary	Percentage of positive ADA	Immunogenicity profile of sc remsima®, consisting on the percentage of positive ADA at 12 months	Month 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of flares of disease	Parameter measuring disease activity between the inclusion visit and the 3 months visit	Month 3
Secondary	Number of flares of disease	Parameter measuring disease activity between the inclusion visit and the 6 months visit	Month 6
Secondary	Number of flares of disease	Parameter measuring disease activity between the inclusion visit and the 12 months visit	Month 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of swollen/painful joints (Rheumatoid arthritis patient)	Parameter measuring disease activity between the inclusion visit and the 3 months visit	Month 3
Secondary	Number of swollen/painful joints (Rheumatoid arthritis patient)	Parameter measuring disease activity between the inclusion visit and the 6 months visit	Month 6
Secondary	Number of swollen/painful joints (Rheumatoid arthritis patient)	Parameter measuring disease activity between the inclusion visit and the 12 months visit	Month 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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