Evaluating the safety of Remsima® SC for treating rheumatoid arthritis and related conditions

An Observational, Prospective Cohort Study to Evaluate Safety of Remsima® Subcutaneous in Patients With Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis and Psoriasis

This study is testing the safety of a new treatment called Remsima® SC for people with rheumatoid arthritis and related conditions to see how well it works for those who haven't had other biologic treatments or haven't responded well to current options.

Quick facts

• Study type: Observational
• Enrollment: 864 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Celltrion (Industry-sponsored)
• Drugs / interventions: infliximab, methotrexate
• Locations: 1 site (Toulouse)
• Trial ID: NCT05866614 on ClinicalTrials.gov

What this trial studies

This observational, prospective cohort study aims to assess the safety of Remsima® SC, a biosimilar to Remicade®, in patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), and psoriasis (Ps). The study will evaluate adverse events of special interest (AESI) associated with the treatment. Eligible patients include those with inadequate responses to existing therapies or those who are biologic-naïve. The study will provide insights into the safety profile of Remsima® SC in these patient populations.

Who should consider this trial

Good fit: Ideal candidates include patients with active RA, AS, PsA, or moderate to severe psoriasis who have not responded adequately to previous treatments.

Not a fit: Patients who are not experiencing active disease or those who have not failed previous therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable safety data that may enhance treatment options for patients with these chronic inflammatory conditions.

How similar studies have performed: Other studies evaluating the safety of biosimilars in similar conditions have shown promising results, indicating a potential for success in this approach.

Eligibility 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.

Where this trial is running

Toulouse

• CHU Purpan Hôpital Pierre Paul Riquet — Toulouse, France (Recruiting)

Study contacts

• Study coordinator: YounJeong Choi

Conditions Rheumatoid Arthritis; Ankylosing Spondylitis; Psoriatic Arthritis; Psoriasis