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

Last updated: November 18, 2024
Sponsor: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Overall Status: Active - Recruiting

Phase

2/3

Condition

N/A

Treatment

Etanercept

Placebo

Clinical Study ID

NCT06011889
NIGRIR_003SAPHO
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosis of SAPHO syndrome according to modified Kahn criteria from 2003.

  2. Age over 18.

  3. Patient overall disease and pain assessment on VAS both ≥ 4 cm.

  4. Expressing informed consent to participate in the study.

Exclusion

Exclusion Criteria:

  1. According to the Summary of Product Characteristics (SmPC) for Enbrel.

  2. Pregnancy, breastfeeding, inability to use effective contraception during theexamination.

  3. Change in the dose of NSAIDs treatment in the last 4 weeks.

  4. Dose modification of disease-modifying antirheumatic drugs (DMARDs) over the past 12weeks.

  5. Use of biological drugs / synthetic targeted drugs in the last 12 weeks.

  6. Use of corticosteroids (orally or local injections), bisphosphonates and/orantibiotics in the last 4 weeks.

  7. Any medical condition that the investigator judges to contraindicate etanercepttreatment.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Etanercept
Phase: 2/3
Study Start date:
September 04, 2024
Estimated Completion Date:
October 18, 2028

Connect with a study center

  • Centrum Wsparcia Badań Klinicznych

    Warsaw, Mazowieckie 02-637
    Poland

    Active - Recruiting

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