Study of the Efficacy and Safety of Etanercept Treatment in Patients With SAPHO Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Etanercept, Placebo.
- Who it may be relevant to
- Registry conditions: SAPHO Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multicenter, Randomized, Double-blind Clinical Trial Evaluating the Efficacy and Safety of Etanercept Versus Placebo in the Treatment of Patients With SAPHO Syndrome
Overview
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.
Interventions
- Drug Etanercept
treatment with etanercept in addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs - Drug Placebo
treatment with placebo in addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs
Primary outcome measures
- 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 [Time frame: 12 weeks (day 85)]
Secondary outcome measures (12)
- Change in patient-assessed disease activity [Time frame: after 4 and 8 weeks]
- Occurrence of remission [Time frame: after 4, 8 and 12 weeks]
- Occurrence of partial remission [Time frame: after 4, 8 and 12 weeks]
- Occurrence of the patient acceptable symptom state (PASS score) [Time frame: after 4, 8 and 12 weeks]
- Change in physician-assessed disease activity [Time frame: at 4, 8 and 12 week]
- Change in the C-reactive Protein from Randomization Day Score [Time frame: at Weeks 4, 8 and 12]
- Change in the Erythrocyte Sedimentation Rate from Randomization Day Score [Time frame: at Weeks 4, 8 and 12]
- Change in quality of life on the Short Form-36 health survey [Time frame: at 4, 8 and 12 weeks]
- Change in the Work Productivity and Activity Impairments (WPAI) from the Randomization Day Score [Time frame: after 4, 8 and 12 weeks]
- decrease in Ankylosing Spondylitis Disease Activity Score (ASDAS- C-reactive protein) ≥1.1 [Time frame: after 4, 8 and 12 weeks]
- a decrease in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score of at least 50 percent [Time frame: after 4, 8 and 12 weeks]
- status of remission- Ankylosing Spondylitis Disease Activity Score (ASDAS- C-reactive protein) below 1.3 [Time frame: after 4, 8 and 12 weeks]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Poland · 1 center
- Centrum Wsparcia Badań Klinicznych — Warsaw
Identifiers
NCT: NCT06011889 · NIGRIR_003SAPHO