Status:
RECRUITING
Study of the Efficacy and Safety of Etanercept Treatment in Patients With SAPHO Syndrome
Lead Sponsor:
National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Collaborating Sponsors:
Medical Research Agency, Poland
Conditions:
SAPHO Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 glo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 18 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06011889
Start Date
September 4 2024
End Date
October 18 2028
Last Update
November 19 2024
Active Locations (1)
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1
Centrum Wsparcia Badań Klinicznych
Warsaw, Masovian Voivodeship, Poland, 02-637