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

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

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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