Sub-cutaneous Infliximab in Inflammatory Rheumatic Disease (SIC2)

April 2, 2026 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
    • IDF
      • Paris, IDF, France, 75014
        • Rheumatology Department, Cochin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Month 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Day 0
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
Month 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
Month 6
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
Month 12
Number of sc remsima® discontinuation
Time Frame: Month 3
Number of sc remsima® discontinuation
Month 3
Questionnaire about reasons explaining Remsina discontinuation
Time Frame: Month 3
Reasons of sc remsima® discontinuation
Month 3
Number of sc remsima® discontinuation
Time Frame: Month 6
Number of sc remsima® discontinuation
Month 6
Questionnaire about reasons explaining Remsina discontinuation
Time Frame: Month 6
Reasons of sc remsima® discontinuation
Month 6
Number of sc remsima® discontinuation
Time Frame: Month 12
Number of sc remsima® discontinuation
Month 12
Questionnaire about reasons explaining Remsina discontinuation
Time Frame: Month 12
Reasons of sc remsima® discontinuation
Month 12
Number of missing SC injections
Time Frame: Month 3
Number of missing SC injections
Month 3
Questionnaire about reasons explaining the missing of a scheduled Remsina injection
Time Frame: Month 3
Reasons of missing SC injections
Month 3
Number of missing SC injections
Time Frame: Month 6
Number of missing SC injections
Month 6
Questionnaire about reasons explaining the missing of a scheduled Remsina injection
Time Frame: Month 6
Reasons of missing SC injections
Month 6
Number of missing SC injections
Time Frame: Month 12
Number of missing SC injections
Month 12
Questionnaire about reasons explaining the missing of a scheduled Remsina injection
Time Frame: Month 12
Reasons of missing SC injections
Month 12
Frequencies of serious adverse effects
Time Frame: Month 3
Safety profile of sc remsima®
Month 3
Frequencies of serious adverse effects
Time Frame: Month 6
Safety profile of sc remsima®
Month 6
Frequencies of serious adverse effects
Time Frame: Month 12
Safety profile of sc remsima®
Month 12
Percentage of positive ADA
Time Frame: Month 6
Immunogenicity profile of sc remsima®, consisting on the percentage of positive ADA at 6 months
Month 6
Percentage of positive ADA
Time Frame: Month 12
Immunogenicity profile of sc remsima®, consisting on the percentage of positive ADA at 12 months
Month 12
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
Month 6
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.
Month 12
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
Month 3
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
Month 6
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
Month 12
Number of flares of disease
Time Frame: Month 3
Parameter measuring disease activity between the inclusion visit and the 3 months visit
Month 3
Number of flares of disease
Time Frame: Month 6
Parameter measuring disease activity between the inclusion visit and the 6 months visit
Month 6
Number of flares of disease
Time Frame: Month 12
Parameter measuring disease activity between the inclusion visit and the 12 months visit
Month 12
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
Month 3
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
Month 6
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
Month 12
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
Month 3
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
Month 6
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
Month 12
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
Month 3
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
Month 6
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
Month 12
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)
Month 3
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)
Month 6
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)
Month 12
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)
Month 3
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)
Month 6
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)
Month 12
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
Month 3
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
Month 6
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
Month 12
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)
Month 3
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)
Month 6
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)
Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
URC-CIC Paris Descartes Necker Cochin

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yannick ALLANORE, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 24, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 14, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 16, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 6, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • APHP211217
  • 2021-A02060-41 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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