Authorised Phase II and Phase III (Integrated) 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).

Study of the efficacy and safety of etanercept treatment in patients with SAPHO syndrome

EU CTIS ID: 2024-516919-25-00

What this study is testing

The aim of the proposed clinical trial is to evaluate the efficacy and safety of etanercept therapy compared to placebo in patients with SAPHO syndrome who continue to receive standard treatment with NSAIDs and / or conventional disease-modifying antirheumatic drugs.

  • Phase II and Phase III (Integrated)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 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.

You likely can't join if

  • 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.
  • Use of biological drugs / synthetic targeted drugs in the last 12 weeks.
  • Use of corticosteroids (orally or local injections) in the last 4 weeks.
See the full eligibility criteria
Who can join
  • 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.
What rules you out
  • 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.
  • Use of biological drugs / synthetic targeted drugs in the last 12 weeks.
  • Use of corticosteroids (orally or local injections) in the last 4 weeks.
  • Any medical condition that the investigator judges to contraindicate etanercept treatment.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.