A multicenter, randomized clinical trial comparing the efficacy and safety of certolizumab pegol and belimumab in patients with moderate or severe activity of systemic lupus erythematosus (CERT-SLE)
This research study is looking at two medicines, certolizumab pegol and belimumab, for adults who have a condition called systemic lupus erythematosus (SLE), also known simply as lupus. Participants in the study have lupus that is moderately or severely active. The main goal is to compare how well these two treatments work in reducing lupus symptoms and how safe they are over 52 weeks. Researchers will also look at other important things like how the medicines affect daily life, feelings of tiredness, and if they help reduce the need for other lupus medicines like steroids. This is a Phase 3 study, meaning these medicines have already gone through earlier tests.
At a glance
What is this study about?
This study is a clinical trial focusing on systemic lupus erythematosus (SLE), often just called lupus. Lupus is a long-term (chronic) condition where the body's immune system, which normally fights off infections, mistakenly attacks healthy tissues. This can cause inflammation and damage in many parts of the body, like joints, skin, kidneys, and heart. The study aims to find out if two different medications, certolizumab pegol and belimumab, can effectively help people who have moderate or severe lupus.
Researchers want to see which treatment is better at controlling lupus symptoms and making people feel better. They will be carefully comparing one medicine against the other, like a head-to-head competition, to understand their effectiveness and safety. This is important because finding more effective treatments can help people with lupus lead healthier and more comfortable lives.
The study will follow participants for 52 weeks, which is about a year. During this time, the medical team will regularly check how each person is responding to the treatment. They will look at many aspects of the disease, including how much the symptoms improve, how the medication affects overall well-being, and if it helps reduce common problems like fatigue. This detailed look will help doctors understand the full picture of how these treatments work.
Key takeaways
- This study compares two medicines for moderately or severely active lupus.
- It aims to find out which medicine is better and safer.
- The study lasts for about one year (52 weeks).
- Participation involves regular clinic visits and health checks.
- You can stop participating at any time.
- It's a Phase 3 study, meaning the medicines have been tested before.
Who may be eligible?
To join this study, you must be an adult aged 18 years or older. The study is open to both men and women. Importantly, you need to have been diagnosed with systemic lupus erythematosus (SLE) that is currently considered to be moderate or severe in its activity.
The study team will review your medical history and current health carefully to make sure the study is a good fit for you. There might be some specific health details or other treatments you are currently taking that could mean you can't join, but the study doctors will explain all of this 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 systemic lupus erythematosus (SLE)?
- Is your lupus currently considered moderate or severe?
- Are you able to attend regular clinic visits for about a year?
What does participation involve?
If you decide to take part in this study, you will be given either certolizumab pegol or belimumab. These are medicines given by injection. Over the 52 weeks (about a year) of the study, you will have regular visits to the clinic. During these visits, the study team will: take blood and urine samples, do physical examinations, ask you questions about your symptoms and how you are feeling, and check for any side effects. You'll also complete questionnaires about your quality of life and energy levels. The specific schedule for injections, visits, and assessments will be fully explained by the study team.
Potential risks and benefits
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Common questions
What is systemic lupus erythematosus (SLE)?
Lupus (SLE) is a long-term condition where your body's immune system mistakenly attacks healthy tissues, causing inflammation and damage in different parts of your body.
What does 'moderate or severe activity' mean?
This means your lupus is causing significant symptoms or problems that your doctor believes need active treatment and close monitoring.
What are certolizumab pegol and belimumab?
These are specific types of medicines used to treat lupus by targeting parts of the immune system.
How long will the study last?
The main part of the study where you receive treatment and are closely monitored will last for 52 weeks, which is about one year.
Can I stop participating if I want to?
Yes, you are free to withdraw from the study at any time without giving a reason, and it will not affect your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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