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

N

National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland

Status and phase

Enrolling
Phase 3
Phase 2

Conditions

SAPHO Syndrome

Treatments

Drug: Etanercept
Drug: Placebo

Study type

Interventional

Funder types

Other
NETWORK

Identifiers

NCT06011889
NIGRIR_003SAPHO

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 criteria

  1. According to the Summary of Product Characteristics (SmPC) for Enbrel.
  2. Pregnancy, breastfeeding, inability to use effective contraception during the examination.
  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 12 weeks.
  5. Use of biological drugs / synthetic targeted drugs in the last 12 weeks.
  6. Use of corticosteroids (orally or local injections), bisphosphonates and/or antibiotics in the last 4 weeks.
  7. Any medical condition that the investigator judges to contraindicate etanercept treatment.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups, including a placebo group

Etanercept
Experimental group
Description:
treatment with etanercept in addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs
Treatment:
Drug: Etanercept
Placebo
Placebo Comparator group
Description:
treatment with placeboin addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Central trial contact

Jakub Wroński, PhD, MD

Data sourced from clinicaltrials.gov

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