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Completed

NCT Number: NCT05424926

Sub-cutaneous Infliximab in Inflammatory Rheumatic Disease

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Psoriatic Arthritis, Rheumatoid Autoimmune Diseases Bone Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Psoriatic Arthritis Rheumatic Diseases Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondyloarthritis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rheumatology Department, Cochin Hospital

Paris, IDF, 75014, France

About this study

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®.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

collection of clinical parameters and blood sample

Other
  • 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).

Primary outcomes

  1. Percentage of patients who have agreed to receive SubCutaneous (SC) REMSIMA® and who continued this treatment for at least 6 months.

    Time frame: 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 outcomes

  1. Percentage of patients switching or not switching to remsima® SC

    Time frame: 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

  2. Number of patients who requested to be re-established on intravenous(IV) infliximab

    Time frame: Month 3

    Number of patients who requested to be re-established on iv infliximab

  3. 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

  4. Number of patients who requested to be re-established on iv infliximab

    Time frame: Month 12

    Number of patients who requested to be re-established on iv infliximab

  5. Number of sc remsima® discontinuation

    Time frame: Month 3

    Number of sc remsima® discontinuation

  6. Questionnaire about reasons explaining Remsina discontinuation

    Time frame: Month 3

    Reasons of sc remsima® discontinuation

  7. Number of sc remsima® discontinuation

    Time frame: Month 6

    Number of sc remsima® discontinuation

  8. Questionnaire about reasons explaining Remsina discontinuation

    Time frame: Month 6

    Reasons of sc remsima® discontinuation

  9. Number of sc remsima® discontinuation

    Time frame: Month 12

    Number of sc remsima® discontinuation

  10. Questionnaire about reasons explaining Remsina discontinuation

    Time frame: Month 12

    Reasons of sc remsima® discontinuation

  11. Number of missing SC injections

    Time frame: Month 3

    Number of missing SC injections

  12. Questionnaire about reasons explaining the missing of a scheduled Remsina injection

    Time frame: Month 3

    Reasons of missing SC injections

  13. Number of missing SC injections

    Time frame: Month 6

    Number of missing SC injections

  14. Questionnaire about reasons explaining the missing of a scheduled Remsina injection

    Time frame: Month 6

    Reasons of missing SC injections

  15. Number of missing SC injections

    Time frame: Month 12

    Number of missing SC injections

  16. Questionnaire about reasons explaining the missing of a scheduled Remsina injection

    Time frame: Month 12

    Reasons of missing SC injections

  17. Frequencies of serious adverse effects

    Time frame: Month 3

    Safety profile of sc remsima®

  18. Frequencies of serious adverse effects

    Time frame: Month 6

    Safety profile of sc remsima®

  19. Frequencies of serious adverse effects

    Time frame: Month 12

    Safety profile of sc remsima®

  20. Percentage of positive ADA

    Time frame: Month 6

    Immunogenicity profile of sc remsima®, consisting on the percentage of positive ADA at 6 months

  21. Percentage of positive ADA

    Time frame: Month 12

    Immunogenicity profile of sc remsima®, consisting on the percentage of positive ADA at 12 months

  22. Infliximab trough levels

    Time frame: Month 6

    Immunogenicity profile of sc remsima®, consisting on the course of infliximab trough levels between the inclusion visit and the 6 months visit

  23. Infliximab trough levels

    Time frame: Month 12

    Immunogenicity profile of sc remsima®, consisting on the course of infliximab trough levels between the inclusion visit and the 12 months visit.

  24. Presence or absence of inflammatory flare since the last infusion

    Time frame: Month 3

    Parameter measuring disease activity between the inclusion visit and the 3 months visit

  25. Presence or absence of inflammatory flare since the last infusion

    Time frame: Month 6

    Parameter measuring disease activity between the inclusion visit and the 6 months visit

  26. Presence or absence of inflammatory flare since the last infusion

    Time frame: Month 12

    Parameter measuring disease activity between the inclusion visit and the 12 months visit

  27. Number of flares of disease

    Time frame: Month 3

    Parameter measuring disease activity between the inclusion visit and the 3 months visit

  28. Number of flares of disease

    Time frame: Month 6

    Parameter measuring disease activity between the inclusion visit and the 6 months visit

  29. Number of flares of disease

    Time frame: Month 12

    Parameter measuring disease activity between the inclusion visit and the 12 months visit

  30. Scale of global appreciation of the activity (by the patient)

    Time frame: 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

  31. Scale of global appreciation of the activity (by the patient)

    Time frame: 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

  32. Scale of global appreciation of the activity (by the patient)

    Time frame: 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

  33. Scale of global appreciation of the activity (by the investigator)

    Time frame: 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

  34. Scale of global appreciation of the activity (by the investigator)

    Time frame: 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

  35. Scale of global appreciation of the activity (by the investigator)

    Time frame: 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

  36. Number of swollen/painful joints (Rheumatoid arthritis patient)

    Time frame: Month 3

    Parameter measuring disease activity between the inclusion visit and the 3 months visit

  37. Number of swollen/painful joints (Rheumatoid arthritis patient)

    Time frame: Month 6

    Parameter measuring disease activity between the inclusion visit and the 6 months visit

  38. Number of swollen/painful joints (Rheumatoid arthritis patient)

    Time frame: Month 12

    Parameter measuring disease activity between the inclusion visit and the 12 months visit

  39. Disease Activity Score DAS28 VS (Rheumatoid arthritis patient)

    Time frame: 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)

  40. Disease Activity Score DAS28 VS (Rheumatoid arthritis patient)

    Time frame: 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)

  41. Disease Activity Score DAS28 VS (Rheumatoid arthritis patient)

    Time frame: 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)

  42. Disease Activity Score DAS28 CRP (Rheumatoid arthritis patient)

    Time frame: 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)

  43. Disease Activity Score DAS28 CRP (Rheumatoid arthritis patient)

    Time frame: 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)

  44. Disease Activity Score DAS28 CRP (Rheumatoid arthritis patient)

    Time frame: 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)

  45. BASDAI : Bath Ankylosing Spondylitis Disease Activity Index (Ankylosing Spondylitis patient)

    Time frame: 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

  46. BASDAI : Bath Ankylosing Spondylitis Disease Activity Index (Ankylosing Spondylitis patient)

    Time frame: 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

  47. BASDAI : Bath Ankylosing Spondylitis Disease Activity Index (Ankylosing Spondylitis patient)

    Time frame: 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

  48. Ankylosing Spondylitis Disease Activity Score with CRP (ASDAS-CRP) (Ankylosing Spondylitis patient)

    Time frame: 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)

  49. Ankylosing Spondylitis Disease Activity Score with CRP (ASDAS-CRP) (Ankylosing Spondylitis patient)

    Time frame: 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)

  50. Ankylosing Spondylitis Disease Activity Score with CRP (ASDAS-CRP) (Ankylosing Spondylitis patient)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: SIC2

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jun 21, 2022
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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