A Study to Evaluate the Safety of Remsima® SC in the Treatment of RA, AS, PsA and Ps (NCT05866614) | Clinical Trial Compass
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
evaluation of adverse events of special interest (AESI)
Timeframe: through study completion, an average of 2 years
. 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.