A Study to Evaluate the Safety of Remsima® SC in the Treatment of RA, AS, PsA and Ps

Study Purpose

This is an observational, prospective cohort study to evaluate the safety of Remsima® SC in the treatment of RA, AS, PsA and Ps.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

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.

Observational [Patient Registry]
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

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: 1.
Biologic-naïve patients or. 2. Patients continuing on infliximab IV including Remsima® IV who will switch to Remsima® SC or. 3. Patients continuing on biologic treatments other than infliximab who will switch to Remsima® SC or. 4. Patients continuing on Remsima® SC (having commenced Remsima® SC treatment prior to enrolment)
  • - The Remsima® IV group will include all patients who meet one of the following classification at the time of enrolment: 1.
Biologic-naïve patients or. 2. Patients continuing on biologic treatments other than infliximab who will switch to Remsima® IV or. 3. 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.

Exclusion Criteria:

1. 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. 2. Patients with any reported contraindications for Remsima® SC or Remsima® IV according to the SmPC of each product. 1. Patients with active tuberculosis (TB) 2. 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. 3. Patients with severe infection such as sepsis, abscesses and opportunistic infections (including, disseminated herpes simplex virus, candidiasis but not limited to) 4. Patients with a current or past history of chronic infection with human immunodeficiency virus (HIV), hepatitis B and hepatitis C. 5. Patients with moderate or severe heart failure (New York Heart Association [NYHA] class III/IV) 6. 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 Details

Trial ID:

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.

NCT05866614
Phase

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.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Celltrion
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Psoriasis
Additional Details

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)

Arms & Interventions

Arms

: 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.

: 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.

: 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.

Interventions

Drug: - Remsima IV

Patient will be treated with Remsima IV as per the SmPC or

Drug: - Remsima SC

Patient will be treated with Remsima SC as per the SmPC

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.

International Sites

CHU Purpan Hôpital Pierre Paul Riquet, Toulouse, France

Status

Recruiting

Address

CHU Purpan Hôpital Pierre Paul Riquet

Toulouse, , 31059

Site Contact

YoungJeong Choi

youngjeong.choi@celltrion.com

+82 032 850 5767

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