Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Prospective, randomised, placebo-controlled study of polyvalent intravenous immunoglobulins for the treatment of primary Sjögren's syndrome associated painful sensory neuropathies

This study is for people with Sjögren's syndrome who also suffer from painful nerve damage, called peripheral neuropathy. Researchers want to see if a medication called Privigen, given through a drip, can help reduce pain and improve their ability to do everyday tasks. This is a "Phase III" study, meaning it's a key stage to confirm if the new treatment works better than a dummy treatment (placebo). They will compare how people feel and function after treatment, looking for at least a 20% improvement in pain or disability scores. The study also tracks other important things like quality of life and side effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Les Hopitaux Universitaires De Strasbourg

Enrolment target

Start

08 Oct 2024

What is this study about?

This research study is looking at a new way to treat nerve pain (called "neuropathy") for people who have a condition called Sjögren's syndrome. Sjögren's syndrome is a long-term condition that can cause problems like dry eyes and dry mouth, but it can also affect other parts of the body, including the nerves. When the nerves are affected, it can cause pain, numbness, or tingling, which can be very uncomfortable and make daily activities difficult.

The study aims to find out if a medicine called Privigen can effectively reduce this nerve pain and improve how well people can move and function. Privigen is a type of medicine that contains antibodies, which are natural substances made by the body to fight off infections. In this study, it's given directly into the bloodstream through a drip. To make sure the results are reliable, some people will receive Privigen, while others will receive a simple salt water solution (called a placebo) that doesn't contain any active medicine. This comparison helps researchers determine if any improvements are truly due to Privigen or just to other factors.

This is a "Phase III" study, which means it's a big step towards potentially making this treatment available more widely. The main goal is to see if participants who receive Privigen experience at least a 20% improvement in their pain levels or in their ability to do daily tasks compared to those who receive the placebo. Researchers will check these improvements about three weeks after the last treatment. They will also look at other important things, like overall quality of life, how tired participants feel, symptoms like dry mouth and dry eyes, and any side effects from the treatment.

Key takeaways

This study investigates a treatment for nerve pain in Sjögren's syndrome.
It compares a drug called Privigen to a dummy treatment (placebo).
The main goal is to reduce pain and improve daily function.
Participation involves regular clinic visits and assessments.
You won't know if you're getting the active drug or the placebo.
The study assesses safety and quality of life alongside treatment effectiveness.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. Both men and women are welcome to participate. Most importantly, you must have been diagnosed with primary Sjögren's syndrome, specifically meeting certain criteria. You also need to have nerve damage (peripheral neuropathy) that causes pain, and this nerve damage must have been confirmed by specific tests (called EMG tests).

Your nerve pain should be either a "pure sensitive" type, meaning it mainly affects your senses, or a "sensorimotor" type, affecting both your senses and your movement.

It's important that your doctors have clearly defined your Sjögren's syndrome according to established European and American guidelines. The research team will check all these details carefully to make sure the study includes the right people.

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.

I am 18 years old or older.
I have been diagnosed with primary Sjögren's syndrome by my doctor.
I experience painful nerve damage (peripheral neuropathy).
My nerve damage has been confirmed by specific nerve tests.
I understand I will have regular check-ups and treatments.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to either receive the study medicine (Privigen) or a dummy treatment (placebo) through a drip. You will have regular visits to the clinic for these treatments and for check-ups. During these visits, the study team will carry out assessments to measure your pain levels, how well you can move, and your general well-being. This will likely involve filling out questionnaires and having physical examinations. The total duration of your participation in the study and how often you need to attend clinic appointments will be fully explained by the study team. You will have follow-up assessments after your treatments to track your progress and any potential changes.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a treatment that could improve your painful nerve symptoms. You'll also be closely monitored by medical professionals, and your participation helps advance medical knowledge for others with Sjögren's syndrome. However, there are also potential risks, including side effects from the study medicine or discomfort from clinic visits and procedures. All possible side effects will be explained to you. You are free 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
France

Common questions

What is Sjögren's syndrome?

Sjögren's syndrome is a long-term condition where the body's immune system mistakenly attacks its own healthy cells, often causing dry eyes and dry mouth, and sometimes affecting other organs like the nerves.

What does 'peripheral neuropathy' mean?

Peripheral neuropathy means there's damage to the nerves outside of your brain and spinal cord, which can cause pain, numbness, tingling, or weakness, especially in your hands and feet.

What is Privigen?

Privigen is a medicine made from human antibodies. It's often used to help people with certain immune system problems. In this study, it's being tested to see if it can help with nerve pain in Sjögren's syndrome.

What is a 'placebo'?

A placebo is a dummy treatment, often a salt water solution given through a drip, that looks exactly like the study medicine but doesn’t contain any active ingredients. It helps researchers compare the real treatment's effects.

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

No, in this type of study (called 'blinded'), neither you nor your doctor will know whether you are receiving Privigen or the placebo. This helps ensure the study results are fair and accurate.