Study of the Efficacy and Safety of Etanercept Treatment in Patients With SAPHO Syndrome
Recruiting
Phase 2
Phase 3
Interventional Study
SAPHO Syndrome
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 60 (estimated)
- Sponsor
- National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland · Research network
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About This Trial
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 i…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Diagnosis of SAPHO syndrome according to modified Kahn criteria from 2003.
2. Age over 18.
3. Patient overall disease and pain assessment on VAS both ≥ 4 cm.
4. Expressing informed consent to participate in the study.
Exclusion Criteria:
1. According to the Summary of Produ…
Contacts