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

SAPHO Syndrome Clinical Trial

— SAPHO  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06011889
• Other study ID #: NIGRIR_003SAPHO
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: December 13, 2023
• Est. completion date: October 18, 2028

Study information

• Verified date: August 2023
• Source: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
• Contact: Jakub Wronski, PhD, MD
• Phone: 22 6880632
• Email: jakub.wronski[@]spartanska.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 18, 2028
• Est. primary completion date: October 18, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• SAPHO Syndrome
• Syndrome

Intervention

Drug:
• Etanercept
treatment with etanercept in addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs
• Placebo
treatment with placebo in addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs

Locations

Country	Name	City	State
Poland	Centrum Wsparcia Badan Klinicznych	Warsaw	Mazowieckie

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland	Medical Research Agency, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in the scope of disease activity as assessed by the patient - a decrease in the overall disease activity as assessed by the patient on the Visual Analogue Scale by min. 50 percent after 12 weeks from randomization day and a decrease in pain assessed by the patient on the Visual Analogue Scale by min. 50 percent after 12 weeks from randomization day. The minimum value is - 0, and the maximum value is - 100 mm. The higher scores mean a worse outcome. A decrease by a minimum of 50 percent means a better outcome.	12 weeks (day 85)
Secondary	Change in patient-assessed disease activity	Change in patient-assessed disease activity - a minimum 50 percent decrease in patient-assessed Visual Analogue Scale overall disease activity from the randomization score at weeks 4 and 8 and a minimum 50 percent decrease in patient-assessed Visual Analogue Scale pain from the score on daily basis randomization after 4 and 8 weeks. The minimum value is - 0, and the maximum is - 100 mm. The higher scores mean a worse outcome. A decrease by a minimum of 50 percent means a better outcome.	after 4 and 8 weeks
Secondary	Occurrence of remission	Occurrence of remission - complete resolution of osteoarticular and skin complaints in the patient's assessment - after 4, 8 and 12 weeks from randomization day	after 4, 8 and 12 weeks
Secondary	Occurrence of partial remission	Occurrence of partial remission - complete resolution of osteoarticular or skin symptoms in the patient's assessment - after 4, 8 and 12 weeks from randomization day	after 4, 8 and 12 weeks
Secondary	Occurrence of the patient acceptable symptom state (PASS score)	Occurrence of the patient acceptable symptom state (PASS score) after 4, 8 and 12 weeks from randomization day. Possible answer- "yes" or "no", with "yes" means a better outcome.	after 4, 8 and 12 weeks
Secondary	Change in physician-assessed disease activity	Improvement in physician-assessed disease activity - a minimum 50 percent decrease in physician-assessed overall disease activity on the Visual Analogue Scale from the randomization score at 4, 8 and 12 weeks. The minimum value is - 0, and the maximum is - 100 mm. The higher scores mean a worse outcome. A decrease by a minimum of 50 percent means a better outcome.	at 4, 8 and 12 week
Secondary	Change in the C-reactive Protein from Randomization Day Score	Change in C-reactive Protein from Randomization Day Score at Weeks 4, 8 and 12. A decrease in C-reactive Protein means improvement.	at Weeks 4, 8 and 12
Secondary	Change in the Erythrocyte Sedimentation Rate from Randomization Day Score	Change in the Erythrocyte Sedimentation Rate Score from Randomization Day Score at Weeks 4, 8 and 12. A decrease in the Erythrocyte Sedimentation Rate Score means improvement.	at Weeks 4, 8 and 12
Secondary	Change in quality of life on the Short Form-36 health survey	Change in quality of life on the Short Form -36 (SF-36) health survey from the score on the day of randomization at 4, 8 and 12 weeks. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.	at 4, 8 and 12 weeks
Secondary	Change in the Work Productivity and Activity Impairments (WPAI) from the Randomization Day Score	Change in the Work Productivity and Activity Impairments (WPAI) from the Randomization Day Score after 4, 8 and 12 weeks. WPAI contains four domains. For each domain, the minimum value is 0 percent, and the maximum is 100 percent. Decreased Work Productivity and Activity Impairments (WPAI) Score means improvement.	after 4, 8 and 12 weeks
Secondary	decrease in Ankylosing Spondylitis Disease Activity Score (ASDAS- C-reactive protein) =1.1	In patients with axial involvement, a decrease in Ankylosing Spondylitis Disease Activity Score (ASDAS- C-reactive protein) =1.1 from the Randomization Day Score at weeks 4, 8, and 12. The minimum value is 0, the maximum value is infinity. A decrease means a better outcome.	after 4, 8 and 12 weeks
Secondary	a decrease in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score of at least 50 percent	a decrease in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score of at least 50 percent from the Randomization Day Score at weeks 4, 8, and 12 was achieved (applies to patients with axial involvement). The minimum value is 0, the maximum value is 10. A decrease by a minimum of 50 percent means a better outcome.	after 4, 8 and 12 weeks
Secondary	status of remission- Ankylosing Spondylitis Disease Activity Score (ASDAS- C-reactive protein) below 1.3	status of remission - Ankylosing Spondylitis Disease Activity Score (ASDAS- C-reactive protein) below 1.3 - after 4, 8 and 12 weeks from randomization day (applies to patients with axial involvement). A score below 1.3 means a better outcome.	after 4, 8 and 12 weeks
Secondary	decrease in the Bath Ankylosing Spondylitis Functional Index (BASFI) by a minimum of 50 percent	a decrease in the Bath Ankylosing Spondylitis Functional Index (BASFI) by a minimum of 50 percent compared to the result on the day of randomization after 4, 8 and 12 weeks (applies to patients with axial involvement). The minimum value is 0, the maximum value is 10. A decrease by a minimum of 50 percent means a better outcome.	after 4, 8 and 12 weeks
Secondary	decrease in the Dermatology Life Quality Index (DLQI) by at least 50 percent from the result on the day of randomization	In patients with severe acne - a decrease in the Dermatology Life Quality Index (DLQI) by at least 50 percent from the result on the day of randomization after 4, 8 and 12 weeks. The minimum value is 0, the maximum value is 30. The decrease by a minimum of 50 percent means a better outcome.	after 4, 8 and 12 weeks
Secondary	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	For patients with psoriasis: 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. The minimum value is 0 percent, and the maximum value is 100 percent. The decrease by a minimum of 50 percent means a better outcome.	after 4, 8 and 12 weeks
Secondary	decrease in the Dermatology Life Quality Index (DLQI) by a minimum of 50 percent	For patients with psoriasis: decrease in the Dermatology Life Quality Index (DLQI) by a minimum of 50 percent from the score on the day of randomization after 4, 8 and 12 weeks. The minimum value is 0, the maximum value is 30. The decrease by a minimum of 50 percent means a better outcome.	after 4, 8 and 12 weeks