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

Sponsor

Celltrion (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05866614

Collaborator

(none)

864

Enrollment

Location

49.5

Anticipated Duration (Months)

17.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis Ankylosing Spondylitis Psoriatic Arthritis Psoriasis	Drug: Remsima IV Drug: Remsima SC

Detailed 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)

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

864 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 13, 2023

Anticipated Primary Completion Date :

Mar 1, 2027

Anticipated Study Completion Date :

Mar 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
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 Patient will be treated with Remsima SC as per the SmPC
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 Patient will be treated with Remsima SC as per the SmPC
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 Patient will be treated with Remsima IV as per the SmPC or

Arm

Intervention/Treatment

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

Patient will be treated with Remsima SC as per the SmPC

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

Patient will be treated with Remsima SC as per the SmPC

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

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

Outcome Measures

Primary Outcome Measures

evaluation of adverse events of special interest (AESI) [through study completion, an average of 2 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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.

Exclusion Criteria:

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.