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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Poland
Centrum Wsparcia Badań Klinicznych
RECRUITING
Warsaw
Contact Information
Primary
Jakub Wroński, PhD, MD
jakub.wronski@spartanska.pl
22 6880632
Time Frame
Start Date: 2024-09-04
Estimated Completion Date: 2028-10-18
Participants
Target number of participants: 60
Treatments
Experimental: Etanercept
treatment with etanercept in addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs
Placebo_comparator: Placebo
treatment with placeboin addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs
Related Therapeutic Areas
Sponsors
Collaborators: Medical Research Agency, Poland
Leads: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland