Rheumatoid ArthritisSIC2NCT05424926
Sub-cutaneous Infliximab in Inflammatory Rheumatic Disease
An observational study of Rheumatoid Arthritis and Spondyloarthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Spondyloarthritis, Psoriatic Arthritis
- What is being tested?
- collection of clinical parameters and blood sample
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 24 Feb 2023to 16 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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®.
- Conditions
- Rheumatoid Arthritis, Spondyloarthritis, Psoriatic Arthritis
- Being tested
- collection of clinical parameters and blood sample
- Keywords
- Chronic inflammatory diseases, Biosimilar, Sub-cutaneous route
- Medical subject headings
- Arthritis, Rheumatoid, Spondylarthritis, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of clinical parameters and blood sampleOther
- 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).
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients Receives: Other: collection of clinical parameters and blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 6
Secondary outcomes (50)
Percentage of patients switching or not switching to remsima® SC
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
Measured: Day 0
Number of patients who requested to be re-established on intravenous(IV) infliximab
Number of patients who requested to be re-established on iv infliximab
Measured: Month 3
Number of patients who requested to be re-established on iv infliximab
Number of patients who requested to be re-established on iv infliximab
Measured: Month 6
Number of patients who requested to be re-established on iv infliximab
Number of patients who requested to be re-established on iv infliximab
Measured: Month 12
Number of sc remsima® discontinuation
Number of sc remsima® discontinuation
Measured: Month 3
Questionnaire about reasons explaining Remsina discontinuation
Reasons of sc remsima® discontinuation
Measured: Month 3
Number of sc remsima® discontinuation
Number of sc remsima® discontinuation
Measured: Month 6
Questionnaire about reasons explaining Remsina discontinuation
Reasons of sc remsima® discontinuation
Measured: Month 6
Number of sc remsima® discontinuation
Number of sc remsima® discontinuation
Measured: Month 12
Questionnaire about reasons explaining Remsina discontinuation
Reasons of sc remsima® discontinuation
Measured: Month 12
Number of missing SC injections
Number of missing SC injections
Measured: Month 3
Questionnaire about reasons explaining the missing of a scheduled Remsina injection
Reasons of missing SC injections
Measured: Month 3
Number of missing SC injections
Number of missing SC injections
Measured: Month 6
Questionnaire about reasons explaining the missing of a scheduled Remsina injection
Reasons of missing SC injections
Measured: Month 6
Number of missing SC injections
Number of missing SC injections
Measured: Month 12
Questionnaire about reasons explaining the missing of a scheduled Remsina injection
Reasons of missing SC injections
Measured: Month 12
Frequencies of serious adverse effects
Safety profile of sc remsima®
Measured: Month 3
Frequencies of serious adverse effects
Safety profile of sc remsima®
Measured: Month 6
Frequencies of serious adverse effects
Safety profile of sc remsima®
Measured: Month 12
Percentage of positive ADA
Immunogenicity profile of sc remsima®, consisting on the percentage of positive ADA at 6 months
Measured: Month 6
Percentage of positive ADA
Immunogenicity profile of sc remsima®, consisting on the percentage of positive ADA at 12 months
Measured: Month 12
Infliximab trough levels
Immunogenicity profile of sc remsima®, consisting on the course of infliximab trough levels between the inclusion visit and the 6 months visit
Measured: Month 6
Infliximab trough levels
Immunogenicity profile of sc remsima®, consisting on the course of infliximab trough levels between the inclusion visit and the 12 months visit.
Measured: Month 12
Presence or absence of inflammatory flare since the last infusion
Parameter measuring disease activity between the inclusion visit and the 3 months visit
Measured: Month 3
Presence or absence of inflammatory flare since the last infusion
Parameter measuring disease activity between the inclusion visit and the 6 months visit
Measured: Month 6
Presence or absence of inflammatory flare since the last infusion
Parameter measuring disease activity between the inclusion visit and the 12 months visit
Measured: Month 12
Number of flares of disease
Parameter measuring disease activity between the inclusion visit and the 3 months visit
Measured: Month 3
Number of flares of disease
Parameter measuring disease activity between the inclusion visit and the 6 months visit
Measured: Month 6
Number of flares of disease
Parameter measuring disease activity between the inclusion visit and the 12 months visit
Measured: Month 12
Scale of global appreciation of the activity (by the patient)
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
Measured: Month 3
Scale of global appreciation of the activity (by the patient)
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
Measured: Month 6
Scale of global appreciation of the activity (by the patient)
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
Measured: Month 12
Scale of global appreciation of the activity (by the investigator)
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
Measured: Month 3
Scale of global appreciation of the activity (by the investigator)
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
Measured: Month 6
Scale of global appreciation of the activity (by the investigator)
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
Measured: Month 12
Number of swollen/painful joints (Rheumatoid arthritis patient)
Parameter measuring disease activity between the inclusion visit and the 3 months visit
Measured: Month 3
Number of swollen/painful joints (Rheumatoid arthritis patient)
Parameter measuring disease activity between the inclusion visit and the 6 months visit
Measured: Month 6
Number of swollen/painful joints (Rheumatoid arthritis patient)
Parameter measuring disease activity between the inclusion visit and the 12 months visit
Measured: Month 12
Disease Activity Score DAS28 VS (Rheumatoid arthritis patient)
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)
Measured: Month 3
Disease Activity Score DAS28 VS (Rheumatoid arthritis patient)
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)
Measured: Month 6
Disease Activity Score DAS28 VS (Rheumatoid arthritis patient)
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)
Measured: Month 12
Disease Activity Score DAS28 CRP (Rheumatoid arthritis patient)
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)
Measured: Month 3
Disease Activity Score DAS28 CRP (Rheumatoid arthritis patient)
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)
Measured: Month 6
Disease Activity Score DAS28 CRP (Rheumatoid arthritis patient)
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)
Measured: Month 12
BASDAI : Bath Ankylosing Spondylitis Disease Activity Index (Ankylosing Spondylitis patient)
Score : 0 to 100 (0 = lowest activity, 100 = highest activity) Parameter measuring disease activity between the inclusion visit and the 3 months visit
Measured: Month 3
BASDAI : Bath Ankylosing Spondylitis Disease Activity Index (Ankylosing Spondylitis patient)
Score : 0 to 100 (0 = lowest activity, 100 = highest activity) Parameter measuring disease activity between the inclusion visit and the 6 months visit
Measured: Month 6
BASDAI : Bath Ankylosing Spondylitis Disease Activity Index (Ankylosing Spondylitis patient)
Score : 0 to 100 (0 = lowest activity, 100 = highest activity) Parameter measuring disease activity between the inclusion visit and the 12 months visit
Measured: Month 12
Ankylosing Spondylitis Disease Activity Score with CRP (ASDAS-CRP) (Ankylosing Spondylitis patient)
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)
Measured: Month 3
Ankylosing Spondylitis Disease Activity Score with CRP (ASDAS-CRP) (Ankylosing Spondylitis patient)
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)
Measured: Month 6
Ankylosing Spondylitis Disease Activity Score with CRP (ASDAS-CRP) (Ankylosing Spondylitis patient)
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)
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start24 Feb 2023
- Primary completion14 Dec 2023
- Study completion16 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Yannick ALLANORE, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424926
- Sponsor's protocol ID
- APHP211217
- Other IDs
- 2021-A02060-41
- Acronym
- SIC2
- Status last verified
- Apr 2026
- First submitted
- 6 Dec 2021
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Switch From Intravenous to Subcutaneous Infliximab (REMSIMA®) in Clinical Practice in the Rheumatology Department of Cochin Hospital
- ClinicalTrials.gov ID
- NCT05424926
- Acronym / sponsor ID
- SIC2 / APHP211217
- Conditions
- Rheumatoid Arthritis, Spondyloarthritis, Psoriatic Arthritis
- Keywords
- Chronic inflammatory diseases, Biosimilar, Sub-cutaneous route
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 24 Feb 2023 (actual)
- Primary completion
- 14 Dec 2023 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: collection of clinical parameters and blood samplePatients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Other | Patients |
Primary outcome
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.
50 secondary outcomes
Percentage of patients switching or not switching to remsima® SC
Time frame: 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
Time frame: Month 6
Number of patients who requested to be re-established on iv infliximab
Time frame: Month 12
Number of sc remsima® discontinuation
Time frame: Month 3
Questionnaire about reasons explaining Remsina discontinuation
Time frame: Month 3
Number of sc remsima® discontinuation
Time frame: Month 6
Questionnaire about reasons explaining Remsina discontinuation
Time frame: Month 6
Number of sc remsima® discontinuation
Time frame: Month 12
Questionnaire about reasons explaining Remsina discontinuation
Time frame: Month 12
Number of missing SC injections
Time frame: Month 3
Questionnaire about reasons explaining the missing of a scheduled Remsina injection
Time frame: Month 3
Number of missing SC injections
Time frame: Month 6
Questionnaire about reasons explaining the missing of a scheduled Remsina injection
Time frame: Month 6
Number of missing SC injections
Time frame: Month 12
Questionnaire about reasons explaining the missing of a scheduled Remsina injection
Time frame: Month 12
Frequencies of serious adverse effects
Time frame: Month 3
Frequencies of serious adverse effects
Time frame: Month 6
Frequencies of serious adverse effects
Time frame: Month 12
Percentage of positive ADA
Time frame: Month 6
Percentage of positive ADA
Time frame: Month 12
Infliximab trough levels
Time frame: Month 6
Infliximab trough levels
Time frame: Month 12
Presence or absence of inflammatory flare since the last infusion
Time frame: Month 3
Presence or absence of inflammatory flare since the last infusion
Time frame: Month 6
Presence or absence of inflammatory flare since the last infusion
Time frame: Month 12
Number of flares of disease
Time frame: Month 3
Number of flares of disease
Time frame: Month 6
Number of flares of disease
Time frame: Month 12
Scale of global appreciation of the activity (by the patient)
Time frame: Month 3
Scale of global appreciation of the activity (by the patient)
Time frame: Month 6
Scale of global appreciation of the activity (by the patient)
Time frame: 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)
Time frame: Month 6
Scale of global appreciation of the activity (by the investigator)
Time frame: Month 12
Number of swollen/painful joints (Rheumatoid arthritis patient)
Time frame: Month 3
Number of swollen/painful joints (Rheumatoid arthritis patient)
Time frame: Month 6
Number of swollen/painful joints (Rheumatoid arthritis patient)
Time frame: Month 12
Disease Activity Score DAS28 VS (Rheumatoid arthritis patient)
Time frame: Month 3
Disease Activity Score DAS28 VS (Rheumatoid arthritis patient)
Time frame: Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yannick ALLANORE, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Spondyloarthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.