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

Recruiting

• Conditions: Rheumatoid Arthritis; Ankylosing Spondylitis; Psoriatic Arthritis; Psoriasis

• Registration Number: NCT05866614
• Lead Sponsor: Celltrion

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-5-8
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 864

Inclusion Criteria

Inclusion Criteria:<br><br>a.Patients with active RA having inadequate response to disease modifying antirheumatic<br>drugs (DMARDs), including methotrexate (MTX) or b.Patients with severe, active and<br>progressive RA not previously treated with MTX or other DMARDs c.Patients with severe,<br>active AS who have responded inadequately to conventional therapy or d.Patients with<br>active and progressive PsA when the response to previous DMARDs has been inadequate or<br>e.Patients with moderate to severe plaque Ps who failed to respond to or who have a<br>contraindication to, or are intolerant to other systemic therapy including cyclosporine,<br>methotrexate or psoralen ultra-violet A.<br><br> - The Remsima® SC group will include all patients who meet one of the following<br> classification at the time of enrolment:<br><br> 1. Biologic-naïve patients or<br><br> 2. Patients continuing on infliximab IV including Remsima® IV who will switch to<br> Remsima® SC or<br><br> 3. Patients continuing on biologic treatments other than infliximab who will<br> switch to Remsima® SC or<br><br> 4. Patients continuing on Remsima® SC (having commenced Remsima® SC treatment<br> prior to enrolment)<br><br> - The Remsima® IV group will include all patients who meet one of the following<br> classification at the time of enrolment:<br><br> 1. Biologic-naïve patients or<br><br> 2. Patients continuing on biologic treatments other than infliximab who will<br> switch to Remsima® IV or<br><br> 3. Patients continuing on infliximab IV including Remsima® IV who will switch to<br> or maintain Remsima® IV * Note: Switching from Remsima® SC to Remsima® IV is<br> not allowed.<br><br>Exclusion Criteria:<br><br> 1. Patients with a history of hypersensitivity to murine, chimeric, human, or humanized<br> proteins or any of the excipients of Remsima® SC or Remsima® IV, whichever the<br> patients are going to be treated in each treatment group, listed in the Summary of<br> Product Characteristics (SmPC) of each product.<br><br> 2. Patients with any reported contraindications for Remsima® SC or Remsima® IV<br> according to the SmPC of each product.<br><br> 1. Patients with active tuberculosis (TB)<br><br> 2. Patients with inactive (latent) TB who are not willing or not compliant with TB<br> prophylaxis or a past diagnosis of TB without sufficient documentation of<br> complete resolution following treatment.<br><br> 3. Patients with severe infection such as sepsis, abscesses and opportunistic<br> infections (including, disseminated herpes simplex virus, candidiasis but not<br> limited to)<br><br> 4. Patients with a current or past history of chronic infection with human<br> immunodeficiency virus (HIV), hepatitis B and hepatitis C<br><br> 5. Patients with moderate or severe heart failure (New York Heart Association<br> [NYHA] class III/IV)<br><br> 6. Patients for whom there are investigator concerns about treatment with tumour<br> necrosis factor alpha (TNF-a) inhibitor, such as a history of any malignancy<br> within the previous five years prior to enrolment, may be excluded at the<br> investigator's discretion.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational [Patient Registry]
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
evaluation of adverse events of special interest (AESI)