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
National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
60 participants
Sep 4, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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.
Exclusion Criteria7
- 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), bisphosphonates and/or antibiotics in the last 4 weeks.
- Any medical condition that the investigator judges to contraindicate etanercept treatment.
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Interventions
treatment with etanercept in addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs
treatment with placebo in addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06011889