Actively Recruiting
Study of the Efficacy and Safety of Etanercept Treatment in Patients With SAPHO Syndrome
Led by National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland · Updated on 2026-04-13
60
Participants Needed
1
Research Sites
215 weeks
Total Duration
On this page
Sponsors
N
National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Lead Sponsor
M
Medical Research Agency, Poland
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of the Efficacy and Safety of Etanercept Treatment in Patients With SAPHO Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of SAPHO syndrome according to modified Kahn criteria from 2003
- Age over 18 years
- Patient overall disease and pain assessment on VAS both 64; 4 cm
- Providing informed consent to participate in the study
You will not qualify if you...
- Contraindications according to the Summary of Product Characteristics for Enbrel
- Pregnancy, breastfeeding, or inability to use effective contraception during the study
- Change in NSAIDs dose in the last 4 weeks
- Dose modification of DMARDs in the last 12 weeks
- Use of biological or synthetic targeted drugs in the last 12 weeks
- Use of corticosteroids (oral or local), bisphosphonates, or antibiotics in the last 4 weeks
- Any medical condition that contraindicates etanercept treatment as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Centrum Wsparcia Badań Klinicznych
Warsaw, Masovian Voivodeship, Poland, 02-637
Actively Recruiting
Research Team
J
Jakub Wroński, PhD, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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