Study on Burfiralimab for Patients with Moderate to Severe Rheumatoid Arthritis

What is this study about?

This clinical trial is focused on studying Rheumatoid Arthritis, a condition that causes pain and swelling in the joints. The study will test a new treatment called Burfiralimab (also known by its code name hzVSF-v13). This treatment is given as a solution through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein. The purpose of the study is to evaluate how effective and safe Burfiralimab is when added to other medications that are commonly used to treat rheumatoid arthritis, especially in patients who have not responded well to at least two other treatments.

Participants in the study will receive either a low dose (200 mg) or a high dose (600 mg) of Burfiralimab, or a placebo. The study will compare the effects of these doses on the activity of the disease. The trial will last for a period of time during which participants will receive the treatment and be monitored for changes in their condition. The study aims to see if Burfiralimab can help reduce the symptoms of rheumatoid arthritis, such as joint swelling and tenderness, and improve overall physical function and quality of life.

Throughout the study, participants will have regular check-ups to assess their response to the treatment. The main goal is to see if there is a significant improvement in the condition of those receiving Burfiralimab compared to those receiving a placebo. The study will also look at other factors, such as pain relief and improvements in daily activities, to determine the overall benefits of the treatment. This research is important for finding new ways to help people with moderate to severe rheumatoid arthritis who have not found relief with existing treatments.

1 initial visit

Upon joining the study, the participant will attend an initial visit. During this visit, the participant will receive detailed information about the study and provide written consent to participate.

The participant will undergo a screening process to confirm eligibility, which includes a negative tuberculosis test and confirmation of rheumatoid arthritis diagnosis.

2 randomization and baseline assessment

The participant will be randomly assigned to receive either the study medication, burfiralimab, or a placebo. This process is double-blind, meaning neither the participant nor the study team will know which treatment is being administered.

Baseline assessments will be conducted to evaluate the participant’s current health status and disease activity.

3 treatment phase

The participant will receive burfiralimab through an intravenous infusion. The dosage will be either 200 mg or 600 mg, depending on the randomization group.

The treatment will be administered in addition to the participant’s existing disease-modifying antirheumatic drugs (DMARDs).

The treatment phase will last for 12 weeks, with regular visits to monitor the participant’s response and any side effects.

4 follow-up assessments

Throughout the 12-week treatment period, the participant will attend follow-up visits to assess the effectiveness of the treatment and monitor health status.

These assessments will include evaluations of disease activity, physical function, pain levels, and overall quality of life.

5 end of treatment evaluation

At the end of the 12-week treatment period, a final evaluation will be conducted to determine the participant’s response to the treatment.

The primary goal is to assess the proportion of participants achieving a clinical response according to the American College of Rheumatology (ACR) 20 criteria.

6 post-treatment follow-up

After completing the treatment phase, the participant will continue to be monitored for any long-term effects or changes in health status.

The participant will be asked to refrain from donating sperm and to use effective birth control methods for 120 days following the last dose of the study medication.

Who Can Join the Study?

The participant must provide written consent to join the study.
The participant must have a negative test for tuberculosis, which is a serious lung infection, at the start of the study.
The participant must not be pregnant or breastfeeding.
If the participant can have children, they must use a highly effective birth control method during the study and for 120 days after the last dose of the study medication.
If the participant is sexually active and has a partner who can become pregnant, they must agree to use effective birth control during the study and for 120 days after the last dose of the study medication.
The participant must agree not to donate sperm during the study and for 120 days after the last treatment with the study medication.
The participant must be able to understand all the information about the study and be willing to attend all study visits, including follow-up checks.
The participant must be between 18 and 80 years old.
The participant must have been diagnosed with rheumatoid arthritis, a condition that causes joint pain and swelling, for at least 3 months before the study starts.
The participant must have moderate to severe rheumatoid arthritis, shown by having at least 2 swollen joints and 6 tender joints.
The participant must have ongoing disease activity despite at least 3 months of treatment or have stopped treatment due to side effects or intolerance.
The participant must have had an inadequate response, loss of response, or intolerance to at least 2 types of advanced medications for rheumatoid arthritis.
The participant must have been taking a medication for rheumatoid arthritis for at least 3 months before the study starts and at a stable dose for at least 1 month.
The participant must test positive for anti-citrullinated protein antibodies, which are markers often found in people with rheumatoid arthritis.
The participant must have a C-reactive protein level higher than normal. C-reactive protein is a substance in the blood that increases when there is inflammation in the body.

Who Cannot Join the Study?

Having any other serious health condition that could interfere with the study.
Being pregnant or breastfeeding.
Having a history of allergic reactions to similar medications.
Using certain medications that might interfere with the study drug.
Having an active infection that requires treatment.
Having a history of drug or alcohol abuse.
Having participated in another clinical trial recently.
Having a condition that affects the immune system, like HIV.
Having a history of cancer, except for some types of skin cancer.
Having a history of heart problems, like heart attack or heart failure.
Having liver or kidney problems.
Having a history of blood disorders.
Having a history of mental health conditions that are not well controlled.
Having received a live vaccine recently.
Having a history of tuberculosis (TB) or being at high risk for TB.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Medical University Of Vienna	Vienna	Austria

Other Sites

Site Name	City	Country
Revmatologicky Ustav	Prague	Czechia
Ko-Med Centra Kliniczne Sp. z o.o.	Lublin	Poland
Bekes Varmegyei Koezponti Korhaz	Gyula	Hungary
Budai Irgalmasrendi Korhaz Nonprofit Kft.	Budapest	Hungary
Silmedic Sp. z o.o.	Katowice	Poland
Medical Plus s.r.o.	Uherske Hradiste	Czechia
AGE Centrum s.r.o.	Olomouc	Czechia
Complex Rendelo Med Zrt.	Szekesfehervar	Hungary
Obudai Egeszseguegyi Centrum Kft.	Dunaújváros	Hungary
Hospital Clinico Universitario De Valencia	Valencia	Spain
Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Sp. p.	Elblag	Poland
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Hospital Clinic De Barcelona	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	01.06.2024
Czechia	Not recruiting	01.06.2024
Hungary	Not recruiting	01.06.2024
Poland	Not recruiting	01.06.2024
Spain	Not recruiting	01.06.2024
The Netherlands	Not recruiting	01.06.2024

Trial locations

Investigated drugs:

Burfiralimab

Burfiralimab (hzVSF-v13) is a medication being studied for its potential to help people with moderate to severe Rheumatoid Arthritis. It is being tested to see if it can improve symptoms when added to other medications that are already used to treat this condition. The goal is to find out if it can help reduce the activity of the disease in patients who have not had enough improvement with other treatments.

Rheumatoid Arthritis – Rheumatoid arthritis is a chronic inflammatory disorder that primarily affects the joints. It occurs when the immune system mistakenly attacks the body’s own tissues, leading to inflammation. Over time, this inflammation can cause damage to the cartilage and bones within the joint. The disease often starts with small joints, such as those in the hands and feet, and can progress to larger joints. Symptoms typically include joint pain, swelling, and stiffness, which can worsen after periods of inactivity. As the disease progresses, it can lead to joint deformity and loss of function.

Trial ID:

2023-507944-35-00

Protocol code:

hzVSF_V13-0015

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Burfiralimab for Patients with Moderate to Severe Rheumatoid Arthritis

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