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

NCT06011889 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

  • SAPHO Syndrome

Interventions

DRUG

Etanercept

treatment with etanercept in addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs

DRUG

Placebo

treatment with placebo in addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs

Sponsors & Collaborators

  • Medical Research Agency, Poland

    collaborator OTHER_GOV

  • National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland

    lead NETWORK

Principal Investigators

  • Jakub Wroński, PhD, MD · National Institute of Geriatrics, Rheumatology and Rehabilitation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-04
Primary Completion
2028-10-18
Completion
2028-10-18

Countries

  • Poland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06011889 on ClinicalTrials.gov