Study of the efficacy and safety of etanercept treatment in patients with SAPHO syndrome
Key facts
- Where
- Olsztyn, Szczecin és Warsaw, LengyelországSee the 3 sites
- Phase
- 2/3. fázis
Where in Lengyelország
- University of Warmia and MazuryOlsztyn, LengyelországTaking people
- Pomeranian Medical UniversitySzczecin, LengyelországTaking people
- Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory ReicherWarsaw, LengyelországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
- Trial code
- EU 2024-516919-25-00
- Record updated
- 2026. április 20.
- Original description
The aim of the proposed clinical trial is to evaluate the efficacy and safety of etanercept therapy compared to placebo in patients with SAPHO syndrome who continue to receive standard treatment with NSAIDs and / or conventional disease-modifying antirheumatic drugs.Read full original descriptionShow less
A multicenter, randomized, double-blind clinical trial evaluating the efficacy and safety of etanercept versus placebo in the treatment of patients with SAPHO syndrome
The aim of the proposed clinical trial is to evaluate the efficacy and safety of etanercept therapy compared to placebo in patients with SAPHO syndrome who continue to receive standard treatment with NSAIDs and / or conventional disease-modifying antirheumatic drugs.
Inclusion: Diagnosis of SAPHO syndrome according to modified Kahn criteria from 2003; Age over 18; Patient overall disease and pain assessment on VAS both ≥ 4 cm; Expressing informed consent to participate in the study.
Exclusion: Use of biological drugs / synthetic targeted drugs in the last 12 weeks; Use of corticosteroids (orally or local injections) in the last 4 weeks; Dose modification of disease-modifying antirheumatic drugs (DMARDs) over the past 12 weeks; Any medical condition that the investigator judges to contraindicate etanercept treatment; According to the Summary of Product Characteristics (SmPC) for Enbrel; Pregnancy, breastfeeding, inability to use effective contraception during the examination; Change in the dose of NSAIDs treatment in the last 4 weeks.