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Comparing certolizumab pegol and belimumab for patients with moderate or severe systemic lupus erythematosus

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study involves patients with systemic lupus erythematosus, a long-term condition where the body's defense system mistakenly attacks its own tissues and organs, causing inflammation and damage to various parts of the body such as joints, skin, kidneys, blood cells, brain, heart, and lungs. The study focuses on patients with moderate or severe disease activity, meaning their symptoms are causing noticeable problems in daily life. The treatments being tested are certolizumab pegol and belimumab, both given as injections under the skin. The purpose of the study is to compare how well these two medications work and how safe they are in controlling the disease activity.

During the study, patients will receive either certolizumab pegol or belimumab for up to 52 weeks, which is about one year. Patients may continue taking their usual medications for lupus, such as pills to control the immune system or reduce inflammation, as long as the doses remain stable. The study will measure several aspects of the disease, including overall disease activity using special scoring systems that look at different body organs and symptoms, the ability to reduce the dose of steroid medications that patients may be taking, changes in joint pain and swelling, skin problems, tiredness levels, and overall quality of life. Doctors will regularly assess how active the disease is and whether patients are experiencing any side effects from the treatment.

The main goal is to see what percentage of patients show meaningful improvement in their disease after one year of treatment, defined as a significant reduction in disease activity scores without any new or worsening symptoms in major organs. The study will also look at whether patients can reduce their steroid doses while keeping their disease under control, since long-term use of steroids can cause unwanted effects. Additionally, researchers will track how patients feel in terms of energy levels, physical functioning, and overall well-being throughout the treatment period.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
Upon joining the study, you will be randomly assigned to receive one of two treatments: either certolizumab pegol or belimumab. Both medications are administered by injection under the skin (subcutaneous injection).
You will continue taking your current medications for lupus if applicable. These may include drugs such as azathioprine, methotrexate, mycophenolate mofetil, hydroxychloroquine, chloroquine, or leflunomide. The doses of these medications must remain stable throughout the study.
If you are taking oral corticosteroids (medications that reduce inflammation, such as prednisone), your dose must not exceed 20 mg per day at the start of the study. Your doctor may adjust this dose during the trial.
Step 2
Week 26 assessment
At week 26, your disease activity will be evaluated. The assessment will include measurements of lupus activity using specific scoring systems and evaluation of your symptoms.
Your doctor will check whether your lupus has improved and whether the dose of corticosteroids has been reduced to less than 10 mg per day.
You will complete questionnaires about fatigue levels to assess how you feel during daily activities.
Step 3
Week 52 primary assessment
At week 52 (approximately one year after starting the study), a comprehensive evaluation of your condition will be performed. This is the main assessment point of the study.
Your doctor will measure improvement in lupus activity using a scoring system called SRI-4 response. This includes checking if your lupus activity score has decreased by at least 4 points, if no new organ involvement has occurred, and if your overall condition has not worsened.
Your doctor will also assess whether your corticosteroid dose has been reduced to less than 10 mg per day.
Additional assessments will include: evaluation of your quality of life using a health survey, measurement of fatigue levels, counting of tender and swollen joints (28 joints will be examined), and assessment of skin lesions if present.
Your doctor will determine if you have achieved a state of low disease activity, which means minimal lupus symptoms with low doses of corticosteroids.
Step 4
Ongoing monitoring throughout the study
Throughout the entire study period, your safety will be monitored. Your doctor will regularly check for any side effects or adverse reactions to the treatment.
You will attend scheduled visits where your lupus activity, symptoms, and overall health will be assessed.
Blood tests may be performed to monitor disease markers and medication effects.
Any changes in your symptoms or new health concerns should be reported to the study team during your visits.

Who can join the trial?

10 criteria

You must sign a document showing you agree to join the study
If you are able to become pregnant, you must agree to not have sexual intercourse or use a very reliable birth control method during the entire study and for at least 5 months after your last dose of certolizumab pegol (a study medicine) or at least 4 months after your last dose of belimumab (another study medicine)
You must be between 18 and 65 years old
You must be able to follow all the study rules and requirements
You must have a confirmed diagnosis of SLE (a disease where your immune system attacks your own body) according to recognized medical classification systems, either before or during the initial study check
You must have a positive antinuclear antibody test (a blood test that looks for certain proteins in your blood) with a level of at least 1:80, AND you must also have at least one of these additional blood test results: antibodies against double-stranded DNA (a specific protein found in your blood) OR anti-Smith antibodies (another specific protein)
Your SLE must be at least moderately active, which means you must meet both of these requirements: a score of 4 or higher on a disease activity measurement scale called SELENA-SLEDAI, AND your doctor must rate your overall disease activity as 1.0 or higher on a scale from 0 to 3
If you are taking certain medicines for your condition, you must be on stable doses for at least 8 weeks before joining the study. Acceptable medicines and their doses include: azathioprine (1 to 2.5 mg per kg of body weight per day), methotrexate (7.5 to 25 mg per week), mycophenolate mofetil (500 to 3000 mg per day), hydroxychloroquine (200 to 400 mg per day), chloroquine (250 to 500 mg per day), or leflunomide (10 to 20 mg per day)
You may continue your standard treatment, but no new treatment should have been started and no treatment should have been stopped in the 8 weeks before the initial study check
If you are taking oral glucocorticosteroids (steroid pills that reduce inflammation), your dose must be 20 mg per day of prednisone or less (or an equivalent amount of a similar medicine), and your dose must have stayed the same for at least 2 weeks before joining the study

Who cannot join the trial?

4 criteria

The source data does not provide specific exclusion criteria (reasons why a patient cannot participate in the study) for this clinical trial
Without detailed exclusion criteria information, it is not possible to list the specific conditions or situations that would prevent participation in this study
Exclusion criteria typically include things like certain other medical conditions, previous treatments, laboratory test results, or medications that would make it unsafe or inappropriate for someone to join the study
The available information only indicates that the study is for patients with moderately active or active systemic lupus erythematosus (a condition where the body's immune system attacks its own tissues and organs), but does not specify who should not participate

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Gornoslaskie Centrum Mwdyczne
Verified
Katowice, Poland
Szpital Uniwersytecki W Krakowie
Verified
Cracow, Poland
Uniwersyteckie Centrum Kliniczne
Verified
Gdansk, Poland

Trial locations

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Investigated drugs

Certolizumab pegol
is a medication that works by blocking a substance in the body called TNF-alpha, which causes inflammation. It is given as an injection under the skin and is being tested in this study to see if it can help reduce the symptoms and activity of systemic lupus erythematosus, a disease where the immune system attacks the body's own tissues.
Belimumab
is a medication that helps control the overactive immune system by targeting and blocking a protein called BLyS, which is involved in the production of antibodies that attack the body. It is already approved for treating systemic lupus erythematosus and is being used in this study as a comparison treatment to see how well certolizumab pegol works against it.

What is already known about the treatment

Certolizumab pegol
This medication is given as an injection under the skin and works by blocking a protein in the body called tumor necrosis factor alpha (TNF-alpha), which causes inflammation. It is currently approved for treating several autoimmune conditions and is being studied in clinical trials for systemic lupus erythematosus, a disease where the immune system attacks the body's own tissues. The drug belongs to a class of medicines called TNF-alpha inhibitors or biologic disease-modifying antirheumatic drugs, which help reduce inflammation and prevent tissue damage by targeting specific parts of the immune system.
Belimumab
This medication is administered either as an injection under the skin or through an intravenous infusion into a vein and is designed to treat systemic lupus erythematosus by reducing the activity of overactive immune cells. It works by blocking a protein called B-lymphocyte stimulator (BLyS), which helps abnormal B cells survive and produce antibodies that attack the body's own tissues. Belimumab is classified as a biologic response modifier or monoclonal antibody and is currently approved as a standard treatment for moderate to severe systemic lupus erythematosus in adults and children. By targeting specific immune system components, it helps control disease activity and reduce symptoms such as joint pain, skin rashes, and fatigue.

Investigated diseases

Systemic Lupus Erythematosus – Systemic lupus erythematosus is a chronic autoimmune disease where the body's immune system mistakenly attacks its own healthy tissues and organs. The disease can affect multiple parts of the body including the skin, joints, kidneys, brain, heart, and lungs. It typically progresses in cycles with periods of increased disease activity called flares, followed by periods of remission when symptoms improve or disappear. During flares, patients may experience joint pain and swelling, skin rashes, extreme fatigue, and fever. The severity of the disease varies widely among patients, ranging from mild to severe forms with significant organ involvement. Over time, the inflammation caused by the disease can lead to permanent damage in affected organs.