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Study of the Efficacy and Safety of Etanercept Treatment in Patients With SAPHO Syndrome
Sponsor: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
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.
Official title: A Multicenter, Randomized, Double-blind Clinical Trial Evaluating the Efficacy and Safety of Etanercept Versus Placebo in the Treatment of Patients With SAPHO Syndrome
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2024-09-04
Completion Date
2028-10-18
Last Updated
2024-11-19
Healthy Volunteers
No
Conditions
Interventions
Etanercept
treatment with etanercept in addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs
Placebo
treatment with placebo in addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs
Locations (1)
Centrum Wsparcia Badań Klinicznych
Warsaw, Masovian Voivodeship, Poland