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

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What is being tested

Etanercept

+ Placebo

Drug
Who is being recruted

Bone Diseases+2

+ Bone Diseases, Developmental

+ Musculoskeletal Diseases

Over 18 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2 & 3
Interventional
Study Start: September 2024
See protocol details

Summary

Principal SponsorNational Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Study ContactJakub Wroński, PhD, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 4, 2024

Actual date on which the first participant was enrolled.

The clinical trial is focused on finding an effective treatment for adults with SAPHO syndrome, a rare condition that causes skin problems and pain in bones and joints. The study aims to compare a medication called Etanercept with a placebo to see if it can better relieve symptoms when standard treatments are not working well. Participants typically have persistent pain and discomfort despite ongoing treatment with certain anti-inflammatory medications or other drugs aimed at managing arthritis. In this study, participants receive either Etanercept or a placebo, with neither the participants nor the researchers knowing which one is given, ensuring unbiased results. The medication is administered under controlled conditions, and researchers closely monitor participants' symptoms using specific measures, like pain levels, over a set period. This approach helps determine the medication's effectiveness and any potential side effects, aiming to improve treatment options for those suffering from SAPHO syndrome.

Official TitleA Multicenter, Randomized, Double-blind Clinical Trial Evaluating the Efficacy and Safety of Etanercept Versus Placebo in the Treatment of Patients With SAPHO Syndrome
NCT06011889
Principal SponsorNational Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Study ContactJakub Wroński, PhD, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bone DiseasesBone Diseases, DevelopmentalMusculoskeletal DiseasesOsteochondrodysplasiasAcquired Hyperostosis Syndrome

Criteria

4 inclusion criteria required to participate
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.
7 exclusion criteria prevent from participating
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.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

Placebo
treatment with placeboin addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Centrum Wsparcia Badań Klinicznych

Warsaw, PolandOpen Centrum Wsparcia Badań Klinicznych in Google Maps
Recruiting
One Study Center