Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
- - 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.
- - Any patient whose doctor considers that he will not be able to comply with the obligations of the trial.
- - Patients under curatorship or tutorship.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Assistance Publique - Hôpitaux de Paris|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Yannick ALLANORE, MD, PhD|
|Principal Investigator Affiliation||Assistance Publique - Hôpitaux de Paris|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Not yet recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Rheumatoid Arthritis, Spondyloarthritis, Psoriatic Arthritis|
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®.
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).
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.