2024-516919-25-00RecruitingPhase 2/3
Study of the efficacy and safety of etanercept treatment in patients with SAPHO syndrome
A multicenter, randomized, double-blind clinical trial evaluating the efficacy and safety of etanercept versus placebo in the treatment of patients with SAPHO syndrome
Source: EU CTIS (euclinicaltrials.eu) · Last updated 20 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 10 Sept 2024
- Start date
- 22 Oct 2024
- Lead sponsor
- Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
- Diseases
- Ankylosing spondylitis, Psoriasis
- EU CT number
- 2024-516919-25-00
- EudraCT number
- 2022-003474-23
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 60
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with SAPHO syndrome who still have active disease and pain while taking standard treatment. It compares etanercept with placebo.
- Age
- Over 18 years
- Sex
- Men and women can join.
- Disease stage
- SAPHO syndrome diagnosed by the modified Kahn criteria from 2003. Overall disease and pain must both score 4 cm or more on the VAS scale.
- Earlier treatment
- No change in NSAID dose in the last 4 weeks. No change in DMARD dose in the last 12 weeks. No biological or targeted synthetic drugs in the last 12 weeks. No corticosteroids (by mouth or local injection) in the last 4 weeks.
Main reasons for not taking part
- Pregnancy or breastfeeding
- Cannot use effective contraception during the study
- Conditions listed in the Enbrel product information (SmPC)
- Any medical condition that the investigator judges to rule out etanercept treatment
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of biological drugs / synthetic targeted drugs in the last 12 weeks.
- Use of corticosteroids (orally or local injections) in the last 4 weeks.
Other illness
- Dose modification of disease-modifying antirheumatic drugs (DMARDs) over the past 12 weeks.
- Any medical condition that the investigator judges to contraindicate etanercept treatment.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Warmia and Mazury | Olsztyn | Poland | Recruiting |
| Pomeranian Medical University | Szczecin | Poland | Recruiting |
| Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher | Warsaw | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.