Clinical trial NCT06011889: Study of the Efficacy and Safety of Etanercept Treatment in Patients With SAPHO Syndrome
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: SAPHO Syndrome
Lead sponsor: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Sponsor class: NETWORK
Collaborators: name: Medical Research Agency, Poland
First posted: 2023-08-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 12 weeks (day 85)
Secondary outcomes:
measure: Change in patient-assessed disease activity
timeFrame: after 4 and 8 weeks
measure: Occurrence of remission
timeFrame: after 4, 8 and 12 weeks
measure: Occurrence of partial remission
timeFrame: after 4, 8 and 12 weeks
measure: Occurrence of the patient acceptable symptom state (PASS score)
timeFrame: after 4, 8 and 12 weeks
measure: Change in physician-assessed disease activity
timeFrame: at 4, 8 and 12 week
measure: Change in the C-reactive Protein from Randomization Day Score
timeFrame: at Weeks 4, 8 and 12
measure: Change in the Erythrocyte Sedimentation Rate from Randomization Day Score
timeFrame: at Weeks 4, 8 and 12
measure: Change in quality of life on the Short Form-36 health survey
timeFrame: at 4, 8 and 12 weeks
measure: Change in the Work Productivity and Activity Impairments (WPAI) from the Randomization Day Score
timeFrame: after 4, 8 and 12 weeks
measure: decrease in Ankylosing Spondylitis Disease Activity Score (ASDAS- C-reactive protein) ≥1.1
timeFrame: after 4, 8 and 12 weeks
measure: a decrease in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score of at least 50 percent
timeFrame: after 4, 8 and 12 weeks
measure: status of remission- Ankylosing Spondylitis Disease Activity Score (ASDAS- C-reactive protein) below 1.3
timeFrame: after 4, 8 and 12 weeks
measure: decrease in the Bath Ankylosing Spondylitis Functional Index (BASFI) by a minimum of 50 percent
timeFrame: after 4, 8 and 12 weeks
measure: decrease in the Dermatology Life Quality Index (DLQI) by at least 50 percent from the result on the day of randomization
timeFrame: after 4, 8 and 12 weeks
measure: decrease in Body Surface Area (BSA) index by a minimum of 50 percent from the score on the day of randomization after 4, 8 and 12 weeks
timeFrame: after 4, 8 and 12 weeks
measure: decrease in the Dermatology Life Quality Index (DLQI) by a minimum of 50 percent
timeFrame: after 4, 8 and 12 weeks
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Centrum Wsparcia Badań Klinicznych
state: Mazowieckie
Study officials:
affiliation: National Institute of Geriatrics, Rheumatology and Rehabilitation
name: Jakub Wroński, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: