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RECRUITING
NCT06011889
PHASE2/PHASE3

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

Sponsor: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland

View on ClinicalTrials.gov

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.

Official title: A Multicenter, Randomized, Double-blind Clinical Trial Evaluating the Efficacy and Safety of Etanercept Versus Placebo in the Treatment of Patients With SAPHO Syndrome

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-09-04

Completion Date

2028-10-18

Last Updated

2024-11-19

Healthy Volunteers

No

Conditions

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

Locations (1)

Centrum Wsparcia Badań Klinicznych

Warsaw, Masovian Voivodeship, Poland