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.