Study of Belimumab versus Placebo for Treatment of Non-infectious Active Cryoglobulinemia Vasculitis in Adult Patients

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What is this study about?

This study focuses on cryoglobulinemia vasculitis, which is a condition where abnormal proteins in the blood cause inflammation of blood vessels. The study will evaluate a medication called belimumab, given as an injection under the skin, compared to a placebo. The purpose is to determine if belimumab is effective in treating people with non-infectious active cryoglobulinemia vasculitis.

The treatment involves receiving rituximab therapy first, followed by either belimumab injections or placebo. Belimumab is given as a 200 mg injection under the skin. The total duration of treatment is 24 weeks. During the study, doctors will monitor how well the treatment works in controlling the symptoms of blood vessel inflammation.

Participants will have regular check-ups to monitor their health and any changes in their condition. The study will look at how well the treatment works in clearing the abnormal proteins from the blood and improving inflammation. Doctors will also track any side effects that may occur during the treatment period.

1 Initial treatment phase

You will receive rituximab as initial therapy (1 to 4 infusions) within 6 weeks before starting the main study treatment

The exact dose will be determined by your doctor

2 Study medication assignment

You will be randomly assigned to receive either Benlysta (belimumab) 200 mg or a placebo

The medication will be given as an injection under the skin (subcutaneous injection)

Neither you nor your doctor will know which treatment you are receiving

3 Treatment period with corticosteroids

You will receive oral corticosteroids (prednisone or prednisolone) along with the study medication

The corticosteroid treatment will continue until week 12

4 Corticosteroid withdrawal

At week 12, the corticosteroid treatment will be stopped completely

5 First evaluation period

Your response to treatment will be evaluated at week 25

The doctors will assess if your vasculitis symptoms have improved

6 Extended follow-up

You will continue to be monitored until week 48

Regular assessments will check your clinical response and any side effects

Blood tests will monitor levels of cryoglobulinemia, rheumatoid factor, and complement

7 Safety monitoring

Throughout the study, you will be monitored for any side effects or adverse reactions

Monthly pregnancy tests will be required for women who can become pregnant

If you have certain hepatitis B markers, you will need regular liver monitoring throughout the study and for 12 months after treatment ends

Who Can Join the Study?

Must be at least 18 years old
Must provide written informed consent to participate in the study
Must have active mixed cryoglobulinemia vasculitis with at least one of these conditions:
– Skin, joint, kidney, nerve, brain, digestive, lung, or heart involvement
– History of positive blood tests showing specific antibodies and protein markers
– Tissue sample showing blood vessel inflammation
Must have received Rituximab treatment (a type of medication) within the past 6 weeks
Must have a neutrophil count (type of white blood cells) above 1×109/L
Must be HIV negative
Must have negative hepatitis B tests (HBs Ag and HBc Ab) or meet specific hepatitis monitoring requirements
Must have either negative hepatitis C test or show no active virus if previously positive
Women who can become pregnant must:
– Have a negative pregnancy test at the start
– Agree to monthly pregnancy testing
– Use effective birth control during the study and for 92 days after
Men who can father children must:
– Use effective birth control during the study
– Continue birth control for 92 days after the last dose

Who Cannot Join the Study?

Previous treatment with belimumab or any other biologic therapy within 6 months before the study
Active or chronic infection with hepatitis B or C virus
History of severe allergic reactions to biological medications
Active tuberculosis or other serious infections requiring treatment
Presence of any other severe medical condition that could interfere with study participation
Pregnancy or breastfeeding
Any form of cancer within the past 5 years (except for successfully treated non-melanoma skin cancer)
Severe kidney disease requiring dialysis
History of drug or alcohol abuse within the past year
Mental health conditions that could affect ability to comply with study procedures
Treatment with another investigational drug within 30 days before the study
History of blood clotting disorders or recent major surgery
Unstable heart disease or recent heart attack within past 6 months
Participation in another clinical trial

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Hopital Beaujon	Clichy	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	20.10.2021

Trial locations

Investigated drugs:

Belimumab

Belimumab is a medication that works by targeting and reducing specific immune system cells that can cause inflammation and damage to blood vessels. It belongs to a class of drugs called monoclonal antibodies. This medication is being studied for treating cryoglobulinemia vasculitis, a condition where abnormal proteins in the blood cause inflammation of blood vessels. Belimumab is already used to treat lupus and may help control the immune system’s overactive response in vasculitis.

Rituximab is mentioned as a previous treatment in the study title. It is also a monoclonal antibody that works by reducing certain types of B cells (immune cells) in the body. While not actively compared in this trial, it’s important to note that patients have received this medication before starting either belimumab or placebo.

Investigated diseases:

Cryoglobulinaemia

Cryoglobulinemia vasculitis – A rare condition where abnormal proteins called cryoglobulins are present in the blood, causing inflammation of blood vessels. These proteins can clump together when exposed to cold temperatures, leading to reduced blood flow to various parts of the body. The condition affects small and medium-sized blood vessels throughout the body, potentially impacting multiple organs. Common manifestations include skin lesions, joint pain, and weakness. The disease can develop gradually over time, with symptoms varying in intensity.

Trial ID:

2024-516237-12-00

Protocol code:

APHP180351

NCT ID:

NCT04629144

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Belimumab versus Placebo for Treatment of Non-infectious Active Cryoglobulinemia Vasculitis in Adult Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?