Rheumatoid ArthritisNCT05866614
A Study to Evaluate the Safety of Remsima® SC in the Treatment of RA, AS, PsA and Ps
An observational study of Rheumatoid Arthritis and Ankylosing Spondylitis, run by Celltrion at 1 site in France.
Trial summary
This is an observational, prospective cohort study to evaluate the safety of Remsima® SC in the treatment of RA, AS, PsA and Ps. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis
- What is being tested?
- Remsima IV and Remsima SC
- Type of treatment
- Injection or infusion
- How many people
- 881 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jan 2023to Mar 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Male or female patients with RA will be enrolled and treated with Remsima® SC. Male or female patients with AS, PsA, and Ps will be enrolled and treated with either Remsima® SC or Remsima® IV. Patients will be considered for enrolment in the study if they meet all of the inclusion criteria and none of the exclusion criteria.
Who may be able to join
- a.Patients with active RA having inadequate response to disease modifying antirheumatic drugs (DMARDs), including methotrexate (MTX) or b.Patients with severe, active and progressive RA not previously treated with MTX or other DMARDs c.Patients with severe, active AS who have responded inadequately to conventional therapy or d.Patients with active and progressive PsA when the response to previous DMARDs has been inadequate or e.Patients with moderate to severe plaque Ps who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultra-violet A.
- The Remsima® SC group will include all patients who meet one of the following classification at the time of enrolment:
- Biologic-naïve patients or
- Patients continuing on infliximab IV including Remsima® IV who will switch to Remsima® SC or
- Patients continuing on biologic treatments other than infliximab who will switch to Remsima® SC or
- Patients continuing on Remsima® SC (having commenced Remsima® SC treatment prior to enrolment)
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- The Remsima® IV group will include all patients who meet one of the following classification at the time of enrolment:
- Biologic-naïve patients or
- Patients continuing on biologic treatments other than infliximab who will switch to Remsima® IV or
- Patients continuing on infliximab IV including Remsima® IV who will switch to or maintain Remsima® IV * Note: Switching from Remsima® SC to Remsima® IV is not allowed.
Who cannot join
- Patients with a history of hypersensitivity to murine, chimeric, human, or humanized proteins or any of the excipients of Remsima® SC or Remsima® IV, whichever the patients are going to be treated in each treatment group, listed in the Summary of Product Characteristics (SmPC) of each product.
- Patients with any reported contraindications for Remsima® SC or Remsima® IV according to the SmPC of each product.
- Patients with active tuberculosis (TB)
- Patients with inactive (latent) TB who are not willing or not compliant with TB prophylaxis or a past diagnosis of TB without sufficient documentation of complete resolution following treatment.
- Patients with severe infection such as sepsis, abscesses and opportunistic infections (including, disseminated herpes simplex virus, candidiasis but not limited to)
- Patients with a current or past history of chronic infection with human immunodeficiency virus (HIV), hepatitis B and hepatitis C
- Patients with moderate or severe heart failure (New York Heart Association [NYHA] class III/IV)
- Patients for whom there are investigator concerns about treatment with tumour necrosis factor alpha (TNF-α) inhibitor, such as a history of any malignancy within the previous five years prior to enrolment, may be excluded at the investigator's discretion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational, Prospective Cohort Study to Evaluate Safety of Remsima® Subcutaneous in Patients With Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis and Psoriasis
This is an observational, prospective cohort study to evaluate the safety of Remsima® SC in the treatment of RA, AS, PsA and Ps.
Read the detailed description
CT-P13(Remsima®) is an IgG1 chimeric human-murine mAb biosimilar to Remicade® (infliximab, Janssen Biologics B.V.) developed by CELLTRION, Inc.The purpose of this study is to assess the safety of Remsima® Subcutaneous (SC) in Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS), Psoriatic Arthritis (PsA) and Psoriasis (Ps) patients by evaluation of adverse events of special interest (AESI)
- Being tested
- Remsima IV, Remsima SC
- Medical subject headings
- Arthritis, Rheumatoid, Spondylitis, Ankylosing, Arthritis, Psoriatic, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remsima IVDrug
Patient will be treated with Remsima IV as per the SmPC or
Remsima SCDrug
Patient will be treated with Remsima SC as per the SmPC
| Study group | Role | What they receive |
|---|---|---|
| CT-P13 SC for RA patients | Patient will be treated as per the SmPC. The enrolled patient with RA will be administered Remsima® SC on the enrolment date and Remsima® SC injections will be continued according to the local standard of care. Study assessment will be done at least every 3 months through outpatient visit or telephone follow-up as part of routine care practice. Each outpatient visit is recommended to be done at least every 6 months and telephone follow-up will be done every 3 months after each outpatient visit to assess the patient. Receives: Drug: Remsima SC | |
| CT-P13 SC for As, PsA and Ps patients | Patient will be treated as per the SmPC. The enrolled patient with AS, PsA, and Ps will be administered Remsima® SC on the enrolment date and Remsima® SC injections will be continued according to the local standard of care. Study assessment will be done at least every 3 months through outpatient visit or telephone follow-up as part of routine care practice. Each outpatient visit is recommended to be done at least every 6 months and telephone follow-up will be done every 3 months after each outpatient visit to assess the patient. Receives: Drug: Remsima SC | |
| CT-P13 IV for As, PsA and Ps patients | Patient will be treated as per the SmPC. The enrolled patient with AS, PsA, and Ps will be administered Remsima® IV on the enrolment date and Remsima® IV infusions will be continued according to the local standard of care. Study assessment will be done at least every 3 months through outpatient visit or telephone follow-up as part of routine care practice. Each outpatient visit is recommended to be done at least every 6 months and telephone follow-up will be done every 3 months after each outpatient visit to assess the patient. Receives: Drug: Remsima IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of adverse events of special interest (AESI)
The safety population will consist of all patients who receive at least 1 (full or partial) dose of either Remsima® SC or Remsima® IV during study period. Analyses will be performed on the observed cases. All safety data will be summarized by treatment groups as appropriate in the Safety population.
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start13 Jan 2023
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
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.
- 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
- 881 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Celltrion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866614
- Sponsor's protocol ID
- CT-P13 4.8
- Status last verified
- Mar 2026
- First submitted
- 8 May 2023
- Last updated
- 31 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Prospective Cohort Study to Evaluate Safety of Remsima® Subcutaneous in Patients With Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis and Psoriasis
- ClinicalTrials.gov ID
- NCT05866614
- Acronym / sponsor ID
- CT-P13 4.8
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 881 participants (actual)
- Lead sponsor
- CelltrionIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 19 May 2023 (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.
This is an observational, prospective cohort study to evaluate the safety of Remsima® SC in the treatment of RA, AS, PsA and Ps.
Detailed description
CT-P13(Remsima®) is an IgG1 chimeric human-murine mAb biosimilar to Remicade® (infliximab, Janssen Biologics B.V.) developed by CELLTRION, Inc.The purpose of this study is to assess the safety of Remsima® Subcutaneous (SC) in Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS), Psoriatic Arthritis (PsA) and Psoriasis (Ps) patients by evaluation of adverse events of special interest (AESI)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CT-P13 SC for RA patients | – | Drug: Remsima SCPatient will be treated as per the SmPC. The enrolled patient with RA will be administered Remsima® SC on the enrolment date and Remsima® SC injections will be continued according to the local standard of care. Study assessment will be done at least every 3 months through outpatient visit or telephone follow-up as part of routine care practice. Each outpatient visit is recommended to be done at least every 6 months and telephone follow-up will be done every 3 months after each outpatient visit to assess the patient. |
| CT-P13 SC for As, PsA and Ps patients | – | Drug: Remsima SCPatient will be treated as per the SmPC. The enrolled patient with AS, PsA, and Ps will be administered Remsima® SC on the enrolment date and Remsima® SC injections will be continued according to the local standard of care. Study assessment will be done at least every 3 months through outpatient visit or telephone follow-up as part of routine care practice. Each outpatient visit is recommended to be done at least every 6 months and telephone follow-up will be done every 3 months after each outpatient visit to assess the patient. |
| CT-P13 IV for As, PsA and Ps patients | – | Drug: Remsima IVPatient will be treated as per the SmPC. The enrolled patient with AS, PsA, and Ps will be administered Remsima® IV on the enrolment date and Remsima® IV infusions will be continued according to the local standard of care. Study assessment will be done at least every 3 months through outpatient visit or telephone follow-up as part of routine care practice. Each outpatient visit is recommended to be done at least every 6 months and telephone follow-up will be done every 3 months after each outpatient visit to assess the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female patients with RA will be enrolled and treated with Remsima® SC. Male or female patients with AS, PsA, and Ps will be enrolled and treated with either Remsima® SC or Remsima® IV. Patients will be considered for enrolment in the study if they meet all of the inclusion criteria and none of the exclusion criteria.
Key inclusion criteria (10 listed)
- a.Patients with active RA having inadequate response to disease modifying antirheumatic drugs (DMARDs), including methotrexate (MTX) or b.Patients with severe, active and progressive RA not previously treated with MTX or other DMARDs c.Patients with severe, active AS who have responded inadequately to conventional therapy or d.Patients with active and progressive PsA when the response to previous DMARDs has been inadequate or e.Patients with moderate to severe plaque Ps who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen ultra-violet A.
- The Remsima® SC group will include all patients who meet one of the following classification at the time of enrolment:
- The Remsima® IV group will include all patients who meet one of the following classification at the time of enrolment:
Key exclusion criteria (8 listed)
- Patients with a history of hypersensitivity to murine, chimeric, human, or humanized proteins or any of the excipients of Remsima® SC or Remsima® IV, whichever the patients are going to be treated in each treatment group, listed in the Summary of Product Characteristics (SmPC) of each product.
- Patients with any reported contraindications for Remsima® SC or Remsima® IV according to the SmPC of each product.
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 |
|---|---|---|
| Remsima IVPatient will be treated with Remsima IV as per the SmPC or | Drug | CT-P13 IV for As, PsA and Ps patients |
| Remsima SCPatient will be treated with Remsima SC as per the SmPC | Drug | CT-P13 SC for As, PsA and Ps patients, CT-P13 SC for RA patients |
Primary outcome
evaluation of adverse events of special interest (AESI)
Time frame: through study completion, an average of 2 years
The safety population will consist of all patients who receive at least 1 (full or partial) dose of either Remsima® SC or Remsima® IV during study period. Analyses will be performed on the observed cases. All safety data will be summarized by treatment groups as appropriate in the Safety population.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ankylosing Spondylitis, run by Celltrion 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 10 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 31 Mar 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?
This study is still under way. Results are not available in the source record yet.
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?
evaluation of adverse events of special interest (AESI) (time frame: through study completion, an average of 2 years). 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 31 Mar 2026.