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

NCT06011889 | Recruiting Phase 2

• 1 other identifier: NIGRIR_003SAPHO
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in the scope of disease activity as assessed by the patient- a decrease in the overall disease activity on the Visual Analogue Scale by min. 50 percent and a decrease in pain assessed by the patient on the Visual Analogue Scale by min. 50 percent

  Change 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 Visual Analogue Scale by min. 50 percent after 12 weeks from randomization day and a decrease in pain assessed by the patient on the Visual Analogue Scale by min. 50 percent after 12 weeks from randomization day. The minimum value is - 0, and the maximum value is - 100 mm. The higher scores mean a worse outcome. A decrease by a minimum of 50 percent means a better outcome.

  12 weeks (day 85)

Secondary Outcomes (16)

• Change in patient-assessed disease activity

  after 4 and 8 weeks

• Occurrence of remission

  after 4, 8 and 12 weeks

• Occurrence of partial remission

  after 4, 8 and 12 weeks

• Occurrence of the patient acceptable symptom state (PASS score)

  after 4, 8 and 12 weeks

• Change in physician-assessed disease activity

  at 4, 8 and 12 week

Study Arms (2)

Etanercept

EXPERIMENTAL

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

Drug: Etanercept

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Etanercept DRUG

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

Etanercept

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Use of biological drugs / synthetic targeted drugs in the last 12 weeks.
• Use of corticosteroids (orally or local injections), bisphosphonates and/or antibiotics in the last 4 weeks.
• Any medical condition that the investigator judges to contraindicate etanercept treatment.

Sponsors & Collaborators

• National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland: lead
• Medical Research Agency, Poland: collaborator

Study Sites (1)

Centrum Wsparcia Badań Klinicznych

Warsaw, Masovian Voivodeship, 02-637, Poland

RECRUITING

MeSH Terms

Conditions

Acquired Hyperostosis Syndrome

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Officials

• Jakub Wroński, PhD, MD

  National Institute of Geriatrics, Rheumatology and Rehabilitation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jakub Wroński, PhD, MD

CONTACT

22 6880632; jakub.wronski@spartanska.pl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 25, 2023
• Study Start: September 4, 2024
• Primary Completion (Estimated): October 18, 2028
• Study Completion (Estimated): October 18, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

PL (1)