Active — Not RecruitingNot Applicable

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

France881 participantsStarted 2023-01-13

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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)
✓. 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.

✕. 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.

evaluation of adverse events of special interest (AESI)

Timeframe: through study completion, an average of 2 years

NCT IDNCT05866614

SponsorCelltrion

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-03

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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)
✓. 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.

✕. 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.