NCT06011889 Study of the Efficacy and Safety of Etanercept Treatment in Patients With SAPHO Syndrome
| NCT ID | NCT06011889 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland |
| Condition | SAPHO Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-09-04 |
| Primary Completion | 2028-10-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2024-09-04 with a primary completion date of 2028-10-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study includes adult patients with SAPHO syndrome (ORPHA: 793), meeting the modified classification criteria according to Kahn (2003), with the ineffectiveness of standard treatment (patient's global assessment of the disease on the VAS scale greater than or equal to 4 cm with accompanying pain on the VAS scale greater than or equal to 4 cm) treated with non-steroidal anti-inflammatory drugs in a stable dose for at least 4 weeks and/or classical disease-modifying antirheumatic drugs in stable doses for at least 12 weeks.
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.
Contact & Investigator
Jakub Wroński, PhD, MD
PRINCIPAL INVESTIGATOR
National Institute of Geriatrics, Rheumatology and Rehabilitation
Frequently Asked Questions
Who can join the NCT06011889 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying SAPHO Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06011889 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06011889 currently recruiting?
Yes, NCT06011889 is actively recruiting participants. Contact the research team at jakub.wronski@spartanska.pl for enrollment information.
Where is the NCT06011889 trial being conducted?
This trial is being conducted at Warsaw, Poland.
Who is sponsoring the NCT06011889 clinical trial?
NCT06011889 is sponsored by National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland. The principal investigator is Jakub Wroński, PhD, MD at National Institute of Geriatrics, Rheumatology and Rehabilitation. The trial plans to enroll 60 participants.