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.
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
22
* 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).
Rheumatology Department, Cochin Hospital
Paris, IDF, France
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.
Time frame: Month 6
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Month 12
Number of sc remsima® discontinuation
Number of sc remsima® discontinuation
Time frame: Month 3
Questionnaire about reasons explaining Remsina discontinuation
Reasons of sc remsima® discontinuation
Time frame: Month 3
Number of sc remsima® discontinuation
Number of sc remsima® discontinuation
Time frame: Month 6
Questionnaire about reasons explaining Remsina discontinuation
Reasons of sc remsima® discontinuation
Time frame: Month 6
Number of sc remsima® discontinuation
Number of sc remsima® discontinuation
Time frame: Month 12
Questionnaire about reasons explaining Remsina discontinuation
Reasons of sc remsima® discontinuation
Time frame: Month 12
Number of missing SC injections
Number of missing SC injections
Time frame: Month 3
Questionnaire about reasons explaining the missing of a scheduled Remsina injection
Reasons of missing SC injections
Time frame: Month 3
Number of missing SC injections
Number of missing SC injections
Time frame: Month 6
Questionnaire about reasons explaining the missing of a scheduled Remsina injection
Reasons of missing SC injections
Time frame: Month 6
Number of missing SC injections
Number of missing SC injections
Time frame: Month 12
Questionnaire about reasons explaining the missing of a scheduled Remsina injection
Reasons of missing SC injections
Time frame: Month 12
Frequencies of serious adverse effects
Safety profile of sc remsima®
Time frame: Month 3
Frequencies of serious adverse effects
Safety profile of sc remsima®
Time frame: Month 6
Frequencies of serious adverse effects
Safety profile of sc remsima®
Time frame: Month 12
Percentage of positive ADA
Immunogenicity profile of sc remsima®, consisting on the percentage of positive ADA at 6 months
Time frame: Month 6
Percentage of positive ADA
Immunogenicity profile of sc remsima®, consisting on the percentage of positive ADA at 12 months
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Month 12
Number of flares of disease
Parameter measuring disease activity between the inclusion visit and the 3 months visit
Time frame: Month 3
Number of flares of disease
Parameter measuring disease activity between the inclusion visit and the 6 months visit
Time frame: Month 6
Number of flares of disease
Parameter measuring disease activity between the inclusion visit and the 12 months visit
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Month 12
Number of swollen/painful joints (Rheumatoid arthritis patient)
Parameter measuring disease activity between the inclusion visit and the 3 months visit
Time frame: Month 3
Number of swollen/painful joints (Rheumatoid arthritis patient)
Parameter measuring disease activity between the inclusion visit and the 6 months visit
Time frame: Month 6
Number of swollen/painful joints (Rheumatoid arthritis patient)
Parameter measuring disease activity between the inclusion visit and the 12 months visit
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Month 12
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