Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Subcutaneous CT-P13 in Patients with Moderately to Severely Active Rheumatoid Arthritis

This study, called a Phase 3 trial, is investigating a new treatment for adults with rheumatoid arthritis that is moderate to severe. The treatment is a medicine called CT-P13, given as an injection under the skin. Researchers want to find out how well it works to reduce arthritis symptoms, like joint pain and swelling, and if it's safe. To do this, some people will receive the new medicine, while others will receive a 'placebo' – a dummy injection that looks the same but contains no active medicine. This helps ensure the results are fair. Other common arthritis medicines like methotrexate, ibuprofen, and paracetamol might also be used at the same time. The main goal is to see how many patients show an improvement in their condition after 12 weeks.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Celltrion Inc.

Enrolment target

189

Start

16 Dec 2024

Rheumatoid arthritis

What is this study about?

This study is looking into a new treatment for a type of arthritis called rheumatoid arthritis. If you have rheumatoid arthritis, your immune system mistakenly attacks your own body, often the joints, causing pain, swelling, and stiffness. When your arthritis is described as 'moderate to severe', it means your symptoms are quite noticeable and affect your daily life.

The new treatment being tested is called CT-P13, and it's given as an injection just under the skin. The main purpose of this study is to see how well CT-P13 helps to reduce symptoms like joint pain and swelling, and also to check if it's safe for people to use. This kind of study is called a 'Phase 3' trial, which means it's one of the final stages of testing a new medicine before it can be made available to everyone.

To make sure the results are fair and accurate, some people in the study will receive the new medicine, while others will receive a 'placebo'. A placebo looks exactly like the real medicine but doesn't contain any active drug. This helps the researchers understand if any improvements are truly due to the new medicine or if they might happen anyway. You and your doctor won't know whether you're getting the active medicine or the placebo. Other common medicines for rheumatoid arthritis, such as methotrexate, ibuprofen, or paracetamol, may also be part of your treatment plan during the study.

Key takeaways

This study is testing a new injectable medicine (CT-P13) for moderate to severe rheumatoid arthritis.
It aims to find out if the new medicine improves symptoms and is safe.
Some participants will receive the active medicine; others will receive a dummy medicine (placebo).
Participation involves regular clinic visits for checks and injections.
You won't know if you're getting the active medicine or the placebo during the study.
You can stop participating at any time without affecting your usual care.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women. The most important requirement is that you have been diagnosed with rheumatoid arthritis, and your condition is considered moderate to severe.

There may be other reasons why you might not be able to join, such as other health conditions you have, or other medications you are currently taking. These details help make sure the study is safe for everyone involved and that the results are clear.

If you're interested, the study team will ask you some questions and do some checks to see if you're a good fit. They will explain everything clearly.

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 a diagnosis of rheumatoid arthritis that is moderate to severe?
Are you open to potentially receiving a placebo (dummy treatment)?
Are you able to attend regular clinic visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have regular visits to the clinic. At these visits, doctors and nurses will check your health, ask about your symptoms, and may take blood samples. You will receive either the study medication (CT-P13) or a placebo, given as an injection under your skin, which you might learn to give yourself at home after initial training. You will also continue to take any other rheumatoid arthritis medicines your doctor prescribes, such as methotrexate, ibuprofen, or paracetamol, as part of your usual care. The main focus will be on how your symptoms change over 12 weeks, but your participation in the study will likely involve follow-up visits after this initial period. The study team will tell you the exact schedule of visits and how long you'll be involved in total.

Potential risks and benefits

Taking part in a study like this might have some potential benefits. You could receive a new treatment that might improve your rheumatoid arthritis symptoms. You will also be closely monitored by a healthcare team. However, there are also potential risks; you might experience side effects from the study medication, or the treatment might not work for you. Since some participants receive a placebo, there's a chance you might not receive the active treatment during the study. You will be given full information about all possible risks. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Poland

Common questions

What is rheumatoid arthritis?

Rheumatoid arthritis is a long-term condition where your body's immune system mistakenly attacks your joints, causing pain, swelling, and stiffness.

What is a 'placebo'?

A placebo is a dummy treatment that looks exactly like the real medicine but contains no active drug. It helps researchers see if the real medicine is truly working.

Will I know if I'm getting the real medicine or the placebo?

No, neither you nor your study doctor will know whether you are receiving the active medicine or the placebo. This is to ensure fair results.

How long will the study last for me?

The main part of the study looks at results after 12 weeks, but your full involvement, including follow-up, will be longer. The study team will give you the exact timeframe.

What if I experience side effects?

The study team will closely monitor you and will explain all possible side effects. You should always tell them about any new or worsening symptoms you experience.