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

May 17, 2023 updated by: Celltrion

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

864

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 Locations

  • France
      • Toulouse, France, 31059

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

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.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Remsima SC
Patient will be treated with Remsima SC as per the SmPC
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.
Drug: Remsima SC
Patient will be treated with Remsima SC as per the SmPC
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.
Drug: Remsima IV
Patient will be treated with Remsima IV as per the SmPC or

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 2 years

Collaborators and Investigators

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

Sponsor

Celltrion

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)

January 13, 2023

Primary Completion (Anticipated)

March 1, 2027

Study Completion (Anticipated)

March 1, 2027

Study Registration Dates

First Submitted

May 8, 2023

First Submitted That Met QC Criteria

May 17, 2023

First Posted (Actual)

May 19, 2023

Study Record Updates

Last Update Posted (Actual)

May 19, 2023

Last Update Submitted That Met QC Criteria

May 17, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT-P13 4.8

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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