Sub-cutaneous Infliximab in Inflammatory Rheumatic Disease
- Conditions
- Psoriatic ArthritisRheumatoid ArthritisSpondyloarthritis
- Interventions
- Other: collection of clinical parameters and blood sample
- Registration Number
- NCT05424926
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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®.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 22
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients collection of clinical parameters and blood sample Patients
- Primary Outcome Measures
Name Time Method Percentage of patients who have agreed to receive SubCutaneous (SC) REMSIMA® and who continued this treatment for at least 6 months. Month 6 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.
- Secondary Outcome Measures
Name Time Method Number of patients who requested to be re-established on intravenous(IV) infliximab Month 3 Number of patients who requested to be re-established on iv infliximab
Percentage of positive ADA Month 12 Immunogenicity profile of sc remsima®, consisting on the percentage of positive ADA at 12 months
Percentage of patients switching or not switching to remsima® SC Day 0 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
Number of patients who requested to be re-established on iv infliximab Month 12 Number of patients who requested to be re-established on iv infliximab
Questionnaire about reasons explaining the missing of a scheduled Remsina injection Month 12 Reasons of missing SC injections
Number of sc remsima® discontinuation Month 12 Number of sc remsima® discontinuation
Questionnaire about reasons explaining Remsina discontinuation Month 12 Reasons of sc remsima® discontinuation
Number of missing SC injections Month 12 Number of missing SC injections
Frequencies of serious adverse effects Month 12 Safety profile of sc remsima®
Infliximab trough levels Month 12 Immunogenicity profile of sc remsima®, consisting on the course of infliximab trough levels between the inclusion visit and the 12 months visit.
Presence or absence of inflammatory flare since the last infusion Month 12 Parameter measuring disease activity between the inclusion visit and the 12 months visit
Number of flares of disease Month 12 Parameter measuring disease activity between the inclusion visit and the 12 months visit
Disease Activity Score DAS28 VS (Rheumatoid arthritis patient) Month 12 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)
Scale of global appreciation of the activity (by the patient) Month 12 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
Scale of global appreciation of the activity (by the investigator) Month 12 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
Number of swollen/painful joints (Rheumatoid arthritis patient) Month 12 Parameter measuring disease activity between the inclusion visit and the 12 months visit
Disease Activity Score DAS28 CRP (Rheumatoid arthritis patient) Month 12 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)
BASDAI : Bath Ankylosing Spondylitis Disease Activity Index (Ankylosing Spondylitis patient) Month 12 Score : 0 to 100 (0 = lowest activity, 100 = highest activity) Parameter measuring disease activity between the inclusion visit and the 12 months visit
Ankylosing Spondylitis Disease Activity Score with CRP (ASDAS-CRP) (Ankylosing Spondylitis patient) Month 12 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)
Trial Locations
- Locations (1)
Rheumatology Department, Cochin Hospital
🇫🇷Paris, IDF, France