Active not recruitingOBSERVATIONAL

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

This study is checking how safe a medicine called Remsima® SC is when used to treat certain conditions. These conditions are Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS), Psoriatic Arthritis (PsA), and Psoriasis (Ps). Remsima® SC is a special type of medicine given as an injection under the skin. The study will watch what happens to people taking this medicine, specifically noting any unwanted effects. It's an important step in making sure new medicines are safe for widespread use. The study is open to both men and women aged 18 and over who have these conditions and meet certain health requirements.

At a glance

Status

Active not recruiting

Sponsor

Celltrion

Enrolment target

881

Start

13 Jan 2023

Estimated completion

01 Mar 2027

Rheumatoid Arthritis Ankylosing Spondylitis Psoriatic Arthritis Psoriasis

What is this study about?

This study is all about understanding how safe a new version of a medicine called Remsima® is. This new version, called Remsima® SC, is given as an injection just under the skin, which can sometimes be more convenient than getting it through a drip. The study focuses on people who have certain long-term conditions: Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, and Psoriasis.

These conditions affect your joints, spine, or skin, causing pain, swelling, and sometimes making it difficult to move. Remsima® is a 'biosimilar' medicine, meaning it's very similar to an existing approved medicine called Remicade®. The main goal of this study is to carefully watch for any side effects or unwanted reactions that people might experience when using Remsima® SC.

By carefully observing many patients, scientists can build a clear picture of its safety. This information is really important because it helps doctors and healthcare providers understand when and how to use Remsima® SC safely and effectively for people living with these conditions.

Key takeaways

The study looks at the safety of a medicine called Remsima® SC.
It's for adults with Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, or Psoriasis.
Remsima® SC is given as an injection under the skin.
The main aim is to find out about any side effects.
You cannot join if you have known allergies to certain medicines or ingredients.

Who may be eligible?

This study is for adults aged 18 or older who have Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS), Psoriatic Arthritis (PsA), or Psoriasis (Ps). For RA, you might be eligible if other treatments haven't worked well enough, or if your RA is quite severe. For AS and PsA, eligibility depends on how well you've responded to other standard treatments.

If you have Psoriasis, you might be considered if your condition is moderate to severe and other typical treatments haven't been effective or you can't take them. Depending on your current treatment, you might either be new to biological medicines, already taking Remsima® through a drip and switching to the under-the-skin injection, or changing from another biological medicine.

However, you can't join if you've ever had a bad allergic reaction to similar medicines (like Remsima® or Remicade®) or any of their ingredients. Also, the study won't be suitable if you have any health conditions that your doctor knows would make Remsima® unsafe for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, or Psoriasis?
Has your current treatment for your condition not worked well enough, or is your condition severe?
Have you *not* had a serious allergic reaction to Remsima® or similar medicines before?

Answer every question to see your result.

What does participation involve?

The detailed information about what taking part involves – such as how many visits you would need, what tests would be done, how often you would take the medicine, and how long the follow-up would last – is not fully described in this summary. Generally, in studies like this, you would receive the study medicine (Remsima® SC or Remsima® IV) as prescribed by your doctor. You would then have regular check-ups with the study team to monitor your health, ask about any side effects, and perform necessary tests. The total duration of your participation would depend on the study plan, but observational studies often involve ongoing monitoring over several months or even years.

Potential risks and benefits

Taking part in this study could offer the benefit of potentially receiving a new way to deliver your medication (an under-the-skin injection) which might be more convenient. However, all medicines carry potential risks, and Remsima® can have side effects. The study aims to carefully identify and understand these. You will be closely monitored, but there's a chance you might experience side effects. You are always free to leave the study at any time, for any reason, without it affecting your usual care.

Locations (1)

CHU Purpan Hôpital Pierre Paul Riquet
Verified postcode
Toulouse, France

Common questions

What is Remsima® SC?

Remsima® SC is a medicine for certain conditions that you inject under your skin.

What conditions is this study looking at?

It's for people with Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, and Psoriasis.

Is Remsima® SC a new type of medicine?

It's a newer version (a 'biosimilar') of an existing medicine, delivered in a different way (under the skin).

Will I get the medicine through a drip or an injection?

Mostly, people in this study will receive Remsima® SC as an injection under the skin, but some might receive it through a drip (Remsima® IV).

What is the main goal of the study?

The main goal is to carefully check for any side effects or unwanted reactions to Remsima® SC to make sure it's safe.