About this trial
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
Qualifiers
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.
Disqualifiers
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.
Dose modification of disease-modifying antirheumatic drugs (DMARDs) over the past 12 weeks.
Trial design
Treatments tested in this trial
- Etanercept
- Placebo
Treatment groups
Sponsors and collaborators
National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Lead sponsor
Medical Research Agency, Poland
Collaborator