Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06011889 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Study of the Efficacy and Safety of Etanercept Treatment in Patients With SAPHO Syndrome

Study acronym: SAPHO
StatusRecruiting
PhasePhase 2/3
Started2024-09-04
View on ClinicalTrials.gov ↗

Amendment history

2026-04-07
Study Status v4
Re-verified, no change to tracked fields
2024-11-18
Study Status v3
Start dateestimated 2023-12-13→confirmed 2024-09-04
2023-11-13
Study Status v2
Start date2023-09-13→2023-12-13
2023-08-29
Study Status, Outcome Measures v1
Start date2023-08-18→2023-09-13
Secondary endpoints16 entries, revised
ImprovementChange in patient-assessed disease activity Occurrence of the state of symptomspatient acceptable forsymptom a patientstate (PASS score) ImprovementChange in physician-assessed disease activity Change in CRPthe C-reactive Protein from Randomization Day Score Change in ESRthe Erythrocyte Sedimentation Rate from Randomization Day Score Change in quality of life on the SFShort Form-36 questionnairehealth survey Change in WPAIthe (Work Productivity and Activity IndexImpairments (WPAI) from the Randomization Day Score decrease in ASDAS-CRPAnkylosing Spondylitis Disease Activity Score (AS [...] [...]
Primary endpoints1 entry, revised
ImprovementChange in the scope of disease activity as assessed by the patient- a decrease in the overall disease activity as assessed by the patient on the VASVisual scaleAnalogue Scale by min. 50% percent and a decrease in pain assessed by the patient on the VASVisual scaleAnalogue Scale by min. 50% percent
2023-08-21
Original filing
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.
Trial Details
NCT Number NCT06011889
Lead Sponsor National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Collaborators: Medical Research Agency, Poland
Conditions SAPHO Syndrome
Enrollment 60 participants
Start Date 2024-09-04
Primary Completion 2028-10-18 (estimated)
Study Completion 2028-10-18 (estimated)
Updated on ClinicalTrials.gov 2026-04-13