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

NCT05866614 | Active Not Recruiting FDA Drug

• 1 other identifier: CT-P13 4.8
• Study Type: observational
• Target: 881
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Psoriasis; Rheumatoid Arthritis; Ankylosing Spondylitis; Psoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

• evaluation of adverse events of special interest (AESI)

  The safety population will consist of all patients who receive at least 1 (full or partial) dose of either Remsima® SC or Remsima® IV during study period. Analyses will be performed on the observed cases. All safety data will be summarized by treatment groups as appropriate in the Safety population.

  through study completion, an average of 2 years

Study Arms (3)

CT-P13 SC for RA patients

Patient will be treated as per the SmPC. The enrolled patient with RA will be administered Remsima® SC on the enrolment date and Remsima® SC injections will be continued according to the local standard of care. Study assessment will be done at least every 3 months through outpatient visit or telephone follow-up as part of routine care practice. Each outpatient visit is recommended to be done at least every 6 months and telephone follow-up will be done every 3 months after each outpatient visit to assess the patient.

Drug: Remsima SC

CT-P13 SC for As, PsA and Ps patients

Patient will be treated as per the SmPC. The enrolled patient with AS, PsA, and Ps will be administered Remsima® SC on the enrolment date and Remsima® SC injections will be continued according to the local standard of care. Study assessment will be done at least every 3 months through outpatient visit or telephone follow-up as part of routine care practice. Each outpatient visit is recommended to be done at least every 6 months and telephone follow-up will be done every 3 months after each outpatient visit to assess the patient.

Drug: Remsima SC

CT-P13 IV for As, PsA and Ps patients

Patient will be treated as per the SmPC. The enrolled patient with AS, PsA, and Ps will be administered Remsima® IV on the enrolment date and Remsima® IV infusions will be continued according to the local standard of care. Study assessment will be done at least every 3 months through outpatient visit or telephone follow-up as part of routine care practice. Each outpatient visit is recommended to be done at least every 6 months and telephone follow-up will be done every 3 months after each outpatient visit to assess the patient.

Drug: Remsima IV

Interventions

Remsima IV DRUG

Patient will be treated with Remsima IV as per the SmPC or

CT-P13 IV for As, PsA and Ps patients

Remsima SC DRUG

Patient will be treated with Remsima SC as per the SmPC

CT-P13 SC for As, PsA and Ps patients; CT-P13 SC for RA patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male or female patients with RA will be enrolled and treated with Remsima® SC. Male or female patients with AS, PsA, and Ps will be enrolled and treated with either Remsima® SC or Remsima® IV. Patients will be considered for enrolment in the study if they meet all of the inclusion criteria and none of the exclusion criteria.

You may qualify if:

• 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:
• Biologic-naïve patients or
• Patients continuing on infliximab IV including Remsima® IV who will switch to Remsima® SC or
• Patients continuing on biologic treatments other than infliximab who will switch to Remsima® SC or
• 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:
• Biologic-naïve patients or
• Patients continuing on biologic treatments other than infliximab who will switch to Remsima® IV or
• 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.

You may not qualify if:

• 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.
• Patients with any reported contraindications for Remsima® SC or Remsima® IV according to the SmPC of each product.
• Patients with active tuberculosis (TB)
• 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.
• Patients with severe infection such as sepsis, abscesses and opportunistic infections (including, disseminated herpes simplex virus, candidiasis but not limited to)
• Patients with a current or past history of chronic infection with human immunodeficiency virus (HIV), hepatitis B and hepatitis C
• Patients with moderate or severe heart failure (New York Heart Association \[NYHA\] class III/IV)
• 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.

Sponsors & Collaborators

• Celltrion: lead

Study Sites (1)

CHU Purpan Hôpital Pierre Paul Riquet

Toulouse, France, 31059, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic; Psoriasis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Ankylosis; Skin Diseases, Papulosquamous; Skin Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 19, 2023
• Study Start: January 13, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

FR (1)