Ongoing Clinical Trials for SAPHO Syndrome

SAPHO syndrome is a rare condition that causes inflammation in the joints and bones, often accompanied by skin problems like severe acne or psoriasis. Currently, there is 1 ongoing clinical trial investigating new treatment options for patients with this condition. This trial is testing the effectiveness and safety of etanercept, a medication that blocks inflammation in the body, when used alongside standard treatments.

Clinical trial locations

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

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

This clinical trial is taking place in Poland and is investigating whether etanercept can help patients living with SAPHO syndrome. The condition causes inflammation in the joints and bones, along with painful skin problems, which can severely affect daily life and overall wellbeing.

Who can participate in this trial?

The trial is looking for participants who meet the following requirements:

• Have been diagnosed with SAPHO syndrome according to the modified Kahn criteria from 2003
• Are over 18 years old
• Experience pain and overall disease symptoms rated at 4 cm or higher on a Visual Analogue Scale (a simple tool where you mark your pain level on a line, with one end representing no pain and the other representing the worst possible pain)
• Are willing to provide informed consent, meaning they understand the study and agree to take part

Who cannot participate?

The trial cannot include patients who:

• Have other serious health conditions that could affect the study
• Are pregnant or breastfeeding
• Have recently had an infection requiring antibiotic treatment
• Have a history of allergic reactions to the study medication or similar drugs
• Are currently taking part in another clinical trial
• Have a history of drug or alcohol abuse
• Have been diagnosed with cancer in the past five years
• Have a weakened immune system, making it harder for their body to fight infections
• Have received a live vaccine within the last four weeks
• Have any other condition that the study doctors believe would make participation unsafe

What is the goal of this trial?

The main purpose of this study is to evaluate whether etanercept, when added to standard treatments like non-steroidal anti-inflammatory drugs (NSAIDs) and other conventional medications, can provide better relief from symptoms compared to a placebo. The researchers will measure whether patients experience a significant reduction in disease activity and pain levels after 12 weeks of treatment. The study aims to determine if etanercept could become a valuable addition to current treatment options, potentially improving quality of life by reducing pain and other troublesome symptoms.

What medication is being tested?

The trial is investigating etanercept, a medication that works by blocking a specific protein in the body responsible for causing inflammation. This can help reduce symptoms such as pain and swelling. Etanercept is given as an injection under the skin, typically once or twice a week. It belongs to a class of medications called tumor necrosis factor (TNF) inhibitors, which are designed to reduce inflammation and slow disease progression.

Patients in the trial will continue receiving their usual care, including NSAIDs for pain relief and inflammation reduction, as well as conventional disease-modifying antirheumatic drugs (DMARDs) if they are already taking them. The study will compare the effects of adding etanercept to these standard treatments versus adding a placebo.

What happens during the trial?

Participants will go through several stages:

1. Joining the study: After providing informed consent and confirming eligibility, patients officially enter the trial.
2. Initial assessment: A thorough examination is conducted to evaluate current health status and disease activity.
3. Treatment phase: Patients receive either etanercept or a placebo through regular injections. The dosage may be 25 mg or 50 mg, depending on the specific formulation. Standard treatments continue as usual.
4. Monitoring and follow-up: Regular visits are scheduled to assess how well the treatment is working and to monitor for any side effects. The main goal is to see if there is a meaningful reduction in disease activity and pain after 12 weeks.
5. Completion: The trial is expected to conclude by July 31, 2028, with a final assessment of the treatment’s effectiveness and safety.

Summary

Currently, there is only one ongoing clinical trial for SAPHO syndrome, which is being conducted in Poland. This trial focuses on testing etanercept, a medication that targets inflammation by blocking specific proteins in the body. The study aims to determine whether this treatment, when combined with standard care, can offer better relief from the chronic pain and inflammation that characterize this rare condition.

The trial represents an important step in finding more effective treatments for SAPHO syndrome, a condition that can significantly impact patients’ quality of life. The use of etanercept, already established in treating other inflammatory conditions, offers hope that it may provide similar benefits for those living with SAPHO syndrome. Patients interested in participating should discuss the opportunity with their healthcare providers to determine if they meet the eligibility requirements.