NCT06011889

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• SAPHO Syndrome

Interventions

Type	Name	Description
DRUG	Etanercept	treatment with etanercept in addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs
DRUG	Placebo	treatment with placebo in addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs

Timeline

• Start date: 2024-09-04
• Primary completion: 2028-10-18
• Completion: 2028-10-18
• First posted: 2023-08-25
• Last updated: 2026-04-13

Locations

1 site across 1 country: Poland