Clinical trial NCT05424926: Sub-cutaneous Infliximab in Inflammatory Rheumatic Disease
Official title: Switch From Intravenous to Subcutaneous Infliximab (REMSIMA®) in Clinical Practice in the Rheumatology Department of Cochin Hospital
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Rheumatoid Arthritis
Spondyloarthritis
Psoriatic Arthritis
Keywords: Chronic inflammatory diseases
Biosimilar
Sub-cutaneous route
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

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®.

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

Primary outcomes:
measure: Percentage of patients who have agreed to receive SubCutaneous (SC) REMSIMA® and who continued this treatment for at least 6 months.
timeFrame: Month 6
Secondary outcomes:
measure: Percentage of patients switching or not switching to remsima® SC
timeFrame: Day 0
measure: Number of patients who requested to be re-established on intravenous(IV) infliximab
timeFrame: Month 3
measure: Number of patients who requested to be re-established on iv infliximab
timeFrame: Month 6
measure: Number of patients who requested to be re-established on iv infliximab
timeFrame: Month 12
measure: Number of sc remsima® discontinuation
timeFrame: Month 3
measure: Questionnaire about reasons explaining Remsina discontinuation
timeFrame: Month 3
measure: Number of sc remsima® discontinuation
timeFrame: Month 6
measure: Questionnaire about reasons explaining Remsina discontinuation
timeFrame: Month 6
measure: Number of sc remsima® discontinuation
timeFrame: Month 12
measure: Questionnaire about reasons explaining Remsina discontinuation
timeFrame: Month 12
measure: Number of missing SC injections
timeFrame: Month 3
measure: Questionnaire about reasons explaining the missing of a scheduled Remsina injection
timeFrame: Month 3
measure: Number of missing SC injections
timeFrame: Month 6
measure: Questionnaire about reasons explaining the missing of a scheduled Remsina injection
timeFrame: Month 6
measure: Number of missing SC injections
timeFrame: Month 12
measure: Questionnaire about reasons explaining the missing of a scheduled Remsina injection
timeFrame: Month 12
measure: Frequencies of serious adverse effects
timeFrame: Month 3
measure: Frequencies of serious adverse effects
timeFrame: Month 6
measure: Frequencies of serious adverse effects
timeFrame: Month 12
measure: Percentage of positive ADA
timeFrame: Month 6
measure: Percentage of positive ADA
timeFrame: Month 12
measure: Infliximab trough levels
timeFrame: Month 6
measure: Infliximab trough levels
timeFrame: Month 12
measure: Presence or absence of inflammatory flare since the last infusion
timeFrame: Month 3
measure: Presence or absence of inflammatory flare since the last infusion
timeFrame: Month 6
measure: Presence or absence of inflammatory flare since the last infusion
timeFrame: Month 12
measure: Number of flares of disease
timeFrame: Month 3
measure: Number of flares of disease
timeFrame: Month 6
measure: Number of flares of disease
timeFrame: Month 12
measure: Scale of global appreciation of the activity (by the patient)
timeFrame: Month 3
measure: Scale of global appreciation of the activity (by the patient)
timeFrame: Month 6
measure: Scale of global appreciation of the activity (by the patient)
timeFrame: Month 12
measure: Scale of global appreciation of the activity (by the investigator)
timeFrame: Month 3
measure: Scale of global appreciation of the activity (by the investigator)
timeFrame: Month 6
measure: Scale of global appreciation of the activity (by the investigator)
timeFrame: Month 12
measure: Number of swollen/painful joints (Rheumatoid arthritis patient)
timeFrame: Month 3
measure: Number of swollen/painful joints (Rheumatoid arthritis patient)
timeFrame: Month 6
measure: Number of swollen/painful joints (Rheumatoid arthritis patient)
timeFrame: Month 12
measure: Disease Activity Score DAS28 VS (Rheumatoid arthritis patient)
timeFrame: Month 3
measure: Disease Activity Score DAS28 VS (Rheumatoid arthritis patient)
timeFrame: Month 6
measure: Disease Activity Score DAS28 VS (Rheumatoid arthritis patient)
timeFrame: Month 12
measure: Disease Activity Score DAS28 CRP (Rheumatoid arthritis patient)
timeFrame: Month 3
measure: Disease Activity Score DAS28 CRP (Rheumatoid arthritis patient)
timeFrame: Month 6
measure: Disease Activity Score DAS28 CRP (Rheumatoid arthritis patient)
timeFrame: Month 12
measure: BASDAI : Bath Ankylosing Spondylitis Disease Activity Index (Ankylosing Spondylitis patient)
timeFrame: Month 3
measure: BASDAI : Bath Ankylosing Spondylitis Disease Activity Index (Ankylosing Spondylitis patient)
timeFrame: Month 6
measure: BASDAI : Bath Ankylosing Spondylitis Disease Activity Index (Ankylosing Spondylitis patient)
timeFrame: Month 12
measure: Ankylosing Spondylitis Disease Activity Score with CRP (ASDAS-CRP) (Ankylosing Spondylitis patient)
timeFrame: Month 3
measure: Ankylosing Spondylitis Disease Activity Score with CRP (ASDAS-CRP) (Ankylosing Spondylitis patient)
timeFrame: Month 6
measure: Ankylosing Spondylitis Disease Activity Score with CRP (ASDAS-CRP) (Ankylosing Spondylitis patient)
timeFrame: Month 12
Other outcomes:
Locations:
city: Paris
country: France
facility: Rheumatology Department, Cochin Hospital
state: IDF
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Yannick ALLANORE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: