SIC2: Sub-cutaneous Infliximab in Inflammatory Rheumatic Disease
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients 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).
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 intravenous(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 patients who requested to be re-established on iv infliximab
- Number of sc remsima® discontinuation [Month 3]
Number of sc remsima® discontinuation
- Questionnaire about reasons explaining Remsina discontinuation [Month 3]
Reasons of sc remsima® discontinuation
- Number of sc remsima® discontinuation [Month 6]
Number of sc remsima® discontinuation
- Questionnaire about reasons explaining Remsina discontinuation [Month 6]
Reasons of sc remsima® discontinuation
- 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 3]
Number of missing SC injections
- Questionnaire about reasons explaining the missing of a scheduled Remsina injection [Month 3]
Reasons of missing SC injections
- Number of missing SC injections [Month 6]
Number of missing SC injections
- Questionnaire about reasons explaining the missing of a scheduled Remsina injection [Month 6]
Reasons of missing SC injections
- Number of missing SC injections [Month 12]
Number of missing SC injections
- Questionnaire about reasons explaining the missing of a scheduled Remsina injection [Month 12]
Reasons of missing SC injections
- Frequencies of serious adverse effects [Month 3]
Safety profile of sc remsima®
- Frequencies of serious adverse effects [Month 6]
Safety profile of sc remsima®
- Frequencies of serious adverse effects [Month 12]
Safety profile of sc remsima®
- Percentage of positive ADA [Month 6]
Immunogenicity profile of sc remsima®, consisting on the percentage of positive ADA at 6 months
- Percentage of positive ADA [Month 12]
Immunogenicity profile of sc remsima®, consisting on the percentage of positive ADA at 12 months
- Infliximab trough levels [Month 6]
Immunogenicity profile of sc remsima®, consisting on the course of infliximab trough levels between the inclusion visit and the 6 months visit
- 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 3]
Parameter measuring disease activity between the inclusion visit and the 3 months visit
- Presence or absence of inflammatory flare since the last infusion [Month 6]
Parameter measuring disease activity between the inclusion visit and the 6 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 3]
Parameter measuring disease activity between the inclusion visit and the 3 months visit
- Number of flares of disease [Month 6]
Parameter measuring disease activity between the inclusion visit and the 6 months visit
- Number of flares of disease [Month 12]
Parameter measuring disease activity between the inclusion visit and the 12 months visit
- Scale of global appreciation of the activity (by the patient) [Month 3]
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
- Scale of global appreciation of the activity (by the patient) [Month 6]
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
- 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 3]
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
- Scale of global appreciation of the activity (by the investigator) [Month 6]
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
- 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 3]
Parameter measuring disease activity between the inclusion visit and the 3 months visit
- Number of swollen/painful joints (Rheumatoid arthritis patient) [Month 6]
Parameter measuring disease activity between the inclusion visit and the 6 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 VS (Rheumatoid arthritis patient) [Month 3]
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)
- Disease Activity Score DAS28 VS (Rheumatoid arthritis patient) [Month 6]
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)
- 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)
- Disease Activity Score DAS28 CRP (Rheumatoid arthritis patient) [Month 3]
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)
- Disease Activity Score DAS28 CRP (Rheumatoid arthritis patient) [Month 6]
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)
- 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 3]
Score : 0 to 100 (0 = lowest activity, 100 = highest activity) Parameter measuring disease activity between the inclusion visit and the 3 months visit
- BASDAI : Bath Ankylosing Spondylitis Disease Activity Index (Ankylosing Spondylitis patient) [Month 6]
Score : 0 to 100 (0 = lowest activity, 100 = highest activity) Parameter measuring disease activity between the inclusion visit and the 6 months visit
- 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 3]
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)
- Ankylosing Spondylitis Disease Activity Score with CRP (ASDAS-CRP) (Ankylosing Spondylitis patient) [Month 6]
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)
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients aged 18 or older
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Patients who has received at least 3 IV infliximab infusions and suffer from chronic inflammatory rheumatic condition
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Absence of disease flare / progressive disease preventing the continuation of infliximab
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Patient affiliated to national insurance
Exclusion Criteria:
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Any patient whose doctor considers that he will not be able to comply with the obligations of the trial
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Patients under curatorship or tutorship
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Pregnant women
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rheumatology Department, Cochin Hospital | Paris | IDF | France | 75014 |
Sponsors and Collaborators
- Assistance Publique - Hôpitaux de Paris
Investigators
- Principal Investigator: Yannick ALLANORE, MD, PhD, Assistance Publique - Hôpitaux de Paris
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- APHP211217
- 2021-A02060-41