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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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)

Eligibility

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 details
    Rheumatoid Arthritis
    Ankylosing Spondylitis
    Psoriatic Arthritis
    Psoriasis

NCT05866614

Celltrion

27 January 2024

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