Treatment of SAPHO syndrome with Etanercept
Official title: A Multicenter, Randomized, Double-blind Clinical Trial Evaluating the Efficacy and Safety of Etanercept Versus Placebo in the Treatment of Patients With SAPHO Syndrome
Run by National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland · NCT06011889 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland Research network |
| Locations | 1 site (Warsaw, Masovian Voivodeship) |
| Status | Recruiting |
| Started | September 4, 2024 |
| Main results expected | October 18, 2028 |
| Study ends | October 18, 2028 |
| Registry record updated | April 13, 2026 |
| Trial ID | NCT06011889 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 with a confirmed diagnosis of SAPHO syndrome who have not found relief from standard treatments.
✕Probably not a fit
Patients who have recently changed their medication regimen or have contraindications to Etanercept will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While there is limited data on Etanercept specifically for SAPHO syndrome, similar biologic treatments have shown promise in managing other inflammatory conditions.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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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
- Email: jakub.wronski@spartanska.pl
- Phone: 22 6880632
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Sleep patterns in psoriatic arthritis and SAPHO syndrome
This project will see how sleep problems, including breathing-related sleep disorders, occur in adults with psoriatic arthritis or SAPHO syndrome who need hospital sleep evaluation.
-
Immune pathways and genetic factors in SAPHO syndrome
This project will test whether specific immune cell patterns and genetic differences in adults with SAPHO syndrome are linked to the disease by collecting blood and other biological samples.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.