Treatment of SAPHO syndrome with Etanercept

A Multicenter, Randomized, Double-blind Clinical Trial Evaluating the Efficacy and Safety of Etanercept Versus Placebo in the Treatment of Patients With SAPHO Syndrome

This study is testing if the medication Etanercept can help adults with SAPHO syndrome who haven't found relief from other treatments.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland (Research network)
• Locations: 1 site (Warsaw, Masovian Voivodeship)
• Trial ID: NCT06011889 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of Etanercept in adult patients diagnosed with SAPHO syndrome who have not responded adequately to standard treatments. Participants must have a significant level of disease activity and pain, as measured by a visual analog scale. The study will compare the effects of Etanercept against a placebo to determine its effectiveness in managing symptoms of SAPHO syndrome. Patients will be monitored for safety and response to treatment throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with a confirmed diagnosis of SAPHO syndrome who have not found relief from standard treatments.

Not a fit: Patients who have recently changed their medication regimen or have contraindications to Etanercept will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from SAPHO syndrome by reducing pain and disease activity.

How similar studies have performed: While there is limited data on Etanercept specifically for SAPHO syndrome, similar biologic treatments have shown promise in managing other inflammatory conditions.

Eligibility criteria

Inclusion Criteria:

1. Diagnosis of SAPHO syndrome according to modified Kahn criteria from 2003.
2. Age over 18.
3. Patient overall disease and pain assessment on VAS both ≥ 4 cm.
4. Expressing informed consent to participate in the study.

Exclusion Criteria:

1. According to the Summary of Product Characteristics (SmPC) for Enbrel.
2. Pregnancy, breastfeeding, inability to use effective contraception during the examination.
3. Change in the dose of NSAIDs treatment in the last 4 weeks.
4. Dose modification of disease-modifying antirheumatic drugs (DMARDs) over the past 12 weeks.
5. Use of biological drugs / synthetic targeted drugs in the last 12 weeks.
6. Use of corticosteroids (orally or local injections), bisphosphonates and/or antibiotics in the last 4 weeks.
7. Any medical condition that the investigator judges to contraindicate etanercept treatment.

Where this trial is running

Warsaw, Masovian Voivodeship

• Centrum Wsparcia Badań Klinicznych — Warsaw, Masovian Voivodeship, Poland (Recruiting)

Study contacts

• Principal investigator: Jakub Wroński, PhD, MD — National Institute of Geriatrics, Rheumatology and Rehabilitation
• Study coordinator: Jakub Wroński, PhD, MD

Conditions SAPHO Syndrome