RecruitingRare disease

Study on the Effectiveness and Safety of Etanercept for Patients with SAPHO Syndrome

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What is this trial about?

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

This clinical trial is focused on studying the effects of a medication called etanercept in patients with a rare condition known as SAPHO syndrome. SAPHO syndrome is a complex disease that involves inflammation of the joints and bones, often accompanied by skin issues like acne or psoriasis. It can cause significant pain and discomfort, affecting daily activities and quality of life. The trial aims to evaluate how effective and safe etanercept is compared to a placebo when used alongside standard treatments such as non-steroidal anti-inflammatory drugs (NSAIDs) and other conventional medications.

Participants in the study will receive either etanercept or a placebo through injections. The study will last for a period of time during which the effects of the treatment on disease activity and pain levels will be monitored. The goal is to see if there is a noticeable improvement in symptoms, such as a reduction in pain and overall disease activity, after 12 weeks of treatment. The study will help determine if etanercept can be a beneficial addition to the current treatment options for SAPHO syndrome.

Throughout the trial, participants will continue their usual care with NSAIDs and other medications as prescribed by their healthcare providers. The study is designed to provide valuable information on whether etanercept can offer additional relief for those suffering from SAPHO syndrome, potentially improving their quality of life by reducing pain and other symptoms associated with the condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient is required to provide informed consent, confirming understanding and willingness to participate.
Eligibility is confirmed based on criteria such as a diagnosis of SAPHO syndrome, age over 18, and a pain assessment score of 4 or higher on a visual scale.
Step 2
Initial assessment
An initial assessment is conducted to evaluate the patient's current health status and disease activity.
This includes a detailed examination and recording of symptoms related to SAPHO syndrome.
Step 3
Treatment phase
The patient receives etanercept, a medication administered through subcutaneous injection.
The dosage is either 25 mg or 50 mg, depending on the specific formulation used.
Injections are given regularly as part of the treatment plan, which continues alongside any standard treatments the patient is already receiving.
Step 4
Monitoring and follow-up
Throughout the trial, the patient's response to treatment is closely monitored.
Regular follow-up visits are scheduled to assess any changes in disease activity and overall health.
The primary goal is to achieve a significant reduction in disease activity and pain, as measured by a visual scale, after 12 weeks.
Step 5
Completion of the trial
The trial is expected to conclude by July 31, 2028.
Upon completion, a final assessment is conducted to evaluate the overall efficacy and safety of the treatment.

Who can join the trial?

4 criteria

Have a diagnosis of SAPHO syndrome according to the modified Kahn criteria from 2003. SAPHO syndrome is a condition that involves joint inflammation and skin issues like acne.
Be over 18 years old.
Rate your overall disease and pain at 4 cm or higher on a Visual Analogue Scale (VAS). This is a tool where you mark your level of pain on a line, with one end being no pain and the other end being the worst pain imaginable.
Agree to participate in the study by providing informed consent. This means you understand the study and agree to take part in it.

Who cannot join the trial?

10 criteria

Patients who have any other serious health condition that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had a recent infection that required treatment with antibiotics.
Patients who have a history of allergic reactions to the study medication or similar drugs.
Patients who are currently participating in another clinical trial.
Patients who have a history of drug or alcohol abuse.
Patients who have been diagnosed with cancer in the past five years.
Patients who have a weakened immune system, which means their body has a harder time fighting infections.
Patients who have received a live vaccine within the last four weeks. A live vaccine contains a small amount of the actual virus or bacteria to help the body build protection.
Patients who have any condition that the study doctors believe would make it unsafe for them to participate.

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Verified sites

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Pomeranian Medical University
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Szczecin, Poland

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Investigated drugs

Etanercept
is a medication used in this clinical trial to treat patients with SAPHO syndrome. It works by blocking a specific protein in the body that causes inflammation, which can help reduce symptoms such as pain and swelling. The trial aims to evaluate how effective and safe etanercept is for patients with this condition.
NSAIDs
(Non-Steroidal Anti-Inflammatory Drugs) are commonly used to relieve pain and reduce inflammation. In this trial, patients continue to receive NSAIDs as part of their standard treatment while being evaluated for the additional effects of etanercept.
Conventional Disease-Modifying Antirheumatic Drugs
(DMARDs) are medications that help slow down the progression of rheumatic diseases and improve symptoms. Patients in the trial may continue using these drugs as part of their regular treatment regimen while the effects of etanercept are being studied.

What is already known about the treatment

Etanercept – Etanercept is administered as an injection under the skin, typically once or twice a week. It is currently being studied in clinical trials for its effectiveness and safety in treating SAPHO syndrome, a rare condition characterized by joint and skin issues. The medication is primarily used to manage autoimmune diseases by blocking a specific protein in the body that causes inflammation. It belongs to the pharmacological class of tumor necrosis factor (TNF) inhibitors, which help reduce inflammation and halt disease progression.

Investigated diseases

SAPHO syndrome – SAPHO syndrome is a rare condition characterized by a combination of joint and bone inflammation, along with skin issues such as pustular psoriasis or acne. Patients often experience chronic pain, which can significantly impact their daily activities and overall quality of life. Approximately half of those affected may also show symptoms of severe axial spondyloarthritis, a type of arthritis affecting the spine. The syndrome can lead to local bone damage, particularly in areas like the sternoclavicular joints.