NCT05424926Completed
Sub-cutaneous Infliximab in Inflammatory Rheumatic Disease
Switch From Intravenous to Subcutaneous Infliximab (REMSIMA®) in Clinical Practice in the Rheumatology Department of Cochin Hospital
Source: ClinicalTrials.gov · Last updated 8 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 22 (actual)
- First submitted
- 6 Dec 2021
- Start date
- 24 Feb 2023
- Primary completion date
- 14 Dec 2023
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Psoriasis, Psoriatic arthritis, Rheumatoid arthritis
- NCT number
- NCT05424926
What you commit to
- Study type: Observational
- Participants enrolled: 22
- From 24 Feb 2023 to the primary completion date, 14 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rheumatology Department, Cochin Hospital Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.