SAPHOA Multicenter, Randomized, Double-blind Clinical Trial Evaluating the Efficacy and Safety of Etanercept Versus Placebo in the Treatment of Patients With SAPHO Syndrome

Etanercept

Placebo

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 patient-assessed disease activity

Occurrence of remission

Occurrence of partial remission

Occurrence of the patient acceptable symptom state (PASS score)

Change in physician-assessed disease activity

Change in the C-reactive Protein from Randomization Day Score

Change in the Erythrocyte Sedimentation Rate from Randomization Day Score

Change in quality of life on the Short Form-36 health survey

Change in the Work Productivity and Activity Impairments (WPAI) from the Randomization Day Score

decrease in Ankylosing Spondylitis Disease Activity Score (ASDAS- C-reactive protein) ≥1.1

a decrease in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score of at least 50 percent

status of remission- Ankylosing Spondylitis Disease Activity Score (ASDAS- C-reactive protein) below 1.3

decrease in the Bath Ankylosing Spondylitis Functional Index (BASFI) by a minimum of 50 percent

decrease in the Dermatology Life Quality Index (DLQI) by at least 50 percent from the result on the day of randomization

decrease in Body Surface Area (BSA) index by a minimum of 50 percent from the score on the day of randomization after 4, 8 and 12 weeks

decrease in the Dermatology Life Quality Index (DLQI) by a minimum of 50 percent