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

Primary Purpose

SAPHO Syndrome

Status
Recruiting
Phase
Phase 2
Locations
Poland
Study Type
Interventional
Intervention
Etanercept
Placebo
Sponsored by
National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SAPHO Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centrum Wsparcia Badań KlinicznychRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Etanercept

Placebo

Arm Description

treatment with etanercept in addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs

treatment with placeboin addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs

Outcomes

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
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.

Secondary Outcome Measures

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.
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
July 28, 2023
Last Updated
August 29, 2023
Sponsor
National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Collaborators
Medical Research Agency, Poland
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1. Study Identification

Unique Protocol Identification Number
NCT06011889
Brief Title
Study of the Efficacy and Safety of Etanercept Treatment in Patients With SAPHO Syndrome
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2023 (Anticipated)
Primary Completion Date
October 18, 2028 (Anticipated)
Study Completion Date
October 18, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
Collaborators
Medical Research Agency, Poland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SAPHO Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Etanercept
Arm Type
Experimental
Arm Description
treatment with etanercept in addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
treatment with placeboin addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs
Intervention Type
Drug
Intervention Name(s)
Etanercept
Intervention Description
treatment with etanercept in addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
treatment with placebo in addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
12 weeks (day 85)
Secondary Outcome Measure Information:
Title
Change in patient-assessed disease activity
Description
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.
Time Frame
after 4 and 8 weeks
Title
Occurrence of remission
Description
Occurrence of remission - complete resolution of osteoarticular and skin complaints in the patient's assessment - after 4, 8 and 12 weeks from randomization day
Time Frame
after 4, 8 and 12 weeks
Title
Occurrence of partial remission
Description
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
Time Frame
after 4, 8 and 12 weeks
Title
Occurrence of the patient acceptable symptom state (PASS score)
Description
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.
Time Frame
after 4, 8 and 12 weeks
Title
Change in physician-assessed disease activity
Description
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.
Time Frame
at 4, 8 and 12 week
Title
Change in the C-reactive Protein from Randomization Day Score
Description
Change in C-reactive Protein from Randomization Day Score at Weeks 4, 8 and 12. A decrease in C-reactive Protein means improvement.
Time Frame
at Weeks 4, 8 and 12
Title
Change in the Erythrocyte Sedimentation Rate from Randomization Day Score
Description
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.
Time Frame
at Weeks 4, 8 and 12
Title
Change in quality of life on the Short Form-36 health survey
Description
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.
Time Frame
at 4, 8 and 12 weeks
Title
Change in the Work Productivity and Activity Impairments (WPAI) from the Randomization Day Score
Description
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.
Time Frame
after 4, 8 and 12 weeks
Title
decrease in Ankylosing Spondylitis Disease Activity Score (ASDAS- C-reactive protein) ≥1.1
Description
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.
Time Frame
after 4, 8 and 12 weeks
Title
a decrease in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score of at least 50 percent
Description
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.
Time Frame
after 4, 8 and 12 weeks
Title
status of remission- Ankylosing Spondylitis Disease Activity Score (ASDAS- C-reactive protein) below 1.3
Description
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.
Time Frame
after 4, 8 and 12 weeks
Title
decrease in the Bath Ankylosing Spondylitis Functional Index (BASFI) by a minimum of 50 percent
Description
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.
Time Frame
after 4, 8 and 12 weeks
Title
decrease in the Dermatology Life Quality Index (DLQI) by at least 50 percent from the result on the day of randomization
Description
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.
Time Frame
after 4, 8 and 12 weeks
Title
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
Description
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.
Time Frame
after 4, 8 and 12 weeks
Title
decrease in the Dermatology Life Quality Index (DLQI) by a minimum of 50 percent
Description
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.
Time Frame
after 4, 8 and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jakub Wroński, PhD, MD
Phone
22 6880632
Ext
+48
Email
jakub.wronski@spartanska.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jakub Wroński, PhD, MD
Organizational Affiliation
National Institute of Geriatrics, Rheumatology and Rehabilitation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centrum Wsparcia Badań Klinicznych
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
02-637
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marta Kurek
Phone
603 315 033
Ext
+48
Email
marta.kurek@spartanska.pl
First Name & Middle Initial & Last Name & Degree
Agnieszka Kurowska
Phone
691 326 114
Ext
+48
Email
agnieszka.kurowska@spartanska.pl

12. IPD Sharing Statement

Learn more about this trial

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

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