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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
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516919-25-00
Acronym
NIGRIR_003SAPHO
Enrollment
60
Registered
2024-10-31
Start date
2024-10-22
Completion date
Unknown
Last updated
2024-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SAPHO syndrome (synovitis, acne, pustulosis, hyperostosis, osteitis) is a rare disease in which arthritis and osteitis is accompanied by skin lesions such as pustular psoriasis or acne. SAPHO syndrome significantly reduces the quality of life of patients due to the chronic occurrence of pain, limiting the daily activity of patients. About half of patients present also with symptoms of severe axial spondyloarthritis. It can also lead to local bone destruction (usually sternoclavicular joints).

Brief summary

Improvement 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 VAS scale by min. 50% after 12 weeks and a decrease in pain assessed by the patient on the VAS scale by min. 50% after 12 weeks

Interventions

Sponsors

Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Improvement 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 VAS scale by min. 50% after 12 weeks and a decrease in pain assessed by the patient on the VAS scale by min. 50% after 12 weeks

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026