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.
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.
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.
Parallel
Etanercept
Drugtreatment with etanercept in addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs
Placebo
Drugtreatment with placebo in addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs
Change in the scope of disease activity as assessed by the patient- a decrease in the overall disease activity on the Visual Analogue Scale by min. 50 percent and a decrease in pain assessed by the patient on the Visual Analogue Scale by min. 50 percent
Change in the scope of disease activity as assessed by the patient - a decrease in the overall disease activity as assessed by the patient on the Visual Analogue Scale by min. 50 percent after 12 weeks from randomization day and a decrease in pain assessed by the patient on the Visual Analogue Scale by min. 50 percent after 12 weeks from randomization day. The minimum value is - 0, and the maximum value is - 100 mm. The higher scores mean a worse outcome. A decrease by a minimum of 50 percent means a better outcome.
Change in patient-assessed disease activity
Change in patient-assessed disease activity - a minimum 50 percent decrease in patient-assessed Visual Analogue Scale overall disease activity from the randomization score at weeks 4 and 8 and a minimum 50 percent decrease in patient-assessed Visual Analogue Scale pain from the score on daily basis randomization after 4 and 8 weeks. The minimum value is - 0, and the maximum is - 100 mm. The higher scores mean a worse outcome. A decrease by a minimum of 50 percent means a better outcome.
Occurrence of remission
Occurrence of remission - complete resolution of osteoarticular and skin complaints in the patient's assessment - after 4, 8 and 12 weeks from randomization day
Occurrence of partial remission
Occurrence of partial remission - complete resolution of osteoarticular or skin symptoms in the patient's assessment - after 4, 8 and 12 weeks from randomization day
Occurrence of the patient acceptable symptom state (PASS score)
Occurrence of the patient acceptable symptom state (PASS score) after 4, 8 and 12 weeks from randomization day. Possible answer- "yes" or "no", with "yes" means a better outcome.
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National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Lead sponsor
Medical Research Agency, Poland
Collaborator
