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

Last updated: August 21, 2024
Sponsor: Celltrion
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dermatomyositis (Connective Tissue Disease)

Warts

Ankylosing Spondylitis

Treatment

Remsima IV

Remsima SC

Clinical Study ID

NCT05866614
CT-P13 4.8
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 followingclassification at the time of enrolment:
  1. Biologic-naïve patients or

  2. Patients continuing on infliximab IV including Remsima® IV who will switch toRemsima® SC or

  3. Patients continuing on biologic treatments other than infliximab who willswitch to Remsima® SC or

  4. Patients continuing on Remsima® SC (having commenced Remsima® SC treatmentprior to enrolment)

  • The Remsima® IV group will include all patients who meet one of the followingclassification at the time of enrolment:
  1. Biologic-naïve patients or

  2. Patients continuing on biologic treatments other than infliximab who willswitch to Remsima® IV or

  3. Patients continuing on infliximab IV including Remsima® IV who will switch toor maintain Remsima® IV * Note: Switching from Remsima® SC to Remsima® IV isnot allowed.

Exclusion

Exclusion Criteria:

  1. Patients with a history of hypersensitivity to murine, chimeric, human, or humanizedproteins or any of the excipients of Remsima® SC or Remsima® IV, whichever thepatients are going to be treated in each treatment group, listed in the Summary ofProduct Characteristics (SmPC) of each product.

  2. Patients with any reported contraindications for Remsima® SC or Remsima® IVaccording to the SmPC of each product.

  3. Patients with active tuberculosis (TB)

  4. Patients with inactive (latent) TB who are not willing or not compliant with TBprophylaxis or a past diagnosis of TB without sufficient documentation ofcomplete resolution following treatment.

  5. Patients with severe infection such as sepsis, abscesses and opportunisticinfections (including, disseminated herpes simplex virus, candidiasis but notlimited to)

  6. Patients with a current or past history of chronic infection with humanimmunodeficiency virus (HIV), hepatitis B and hepatitis C

  7. Patients with moderate or severe heart failure (New York Heart Association [NYHA] class III/IV)

  8. Patients for whom there are investigator concerns about treatment with tumournecrosis factor alpha (TNF-α) inhibitor, such as a history of any malignancywithin the previous five years prior to enrolment, may be excluded at theinvestigator's discretion.

Study Design

Total Participants: 864
Treatment Group(s): 2
Primary Treatment: Remsima IV
Phase:
Study Start date:
January 13, 2023
Estimated Completion Date:
March 31, 2027

Study 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)

Connect with a study center

  • CHU Purpan Hôpital Pierre Paul Riquet

    Toulouse, 31059
    France

    Active - Recruiting

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