Sub-cutaneous Infliximab in Inflammatory Rheumatic Disease

NCT05424926 | Completed

• 2 other identifiers: APHP2112172021-A02060-41
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis; Spondyloarthritis; Psoriatic Arthritis

Keywords

Chronic inflammatory diseases; Biosimilar; Sub-cutaneous route

Outcome Measures

Primary Outcomes (1)

• 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.

  Month 6

Secondary Outcomes (50)

• Percentage of patients switching or not switching to remsima® SC

  Day 0

• 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

  Month 6

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

  Month 12

• Number of sc remsima® discontinuation

  Month 3

Study Arms (1)

Patients

Patients

Other: collection of clinical parameters and blood sample

Interventions

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).

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Rheumatology Department, Cochin Hospital

Paris, IDF, 75014, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Spondylarthritis; Arthritis, Psoriatic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylitis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Yannick ALLANORE, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: June 21, 2022
• Study Start: February 24, 2023
• Primary Completion: December 14, 2023
• Study Completion: December 16, 2024
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)