SAPHO SyndromePhase 2/3SAPHONCT06011889
Study of the Efficacy and Safety of Etanercept Treatment in Patients With SAPHO Syndrome
A Phase 2/3 study testing Etanercept in people with SAPHO Syndrome, run by National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland at 1 site in Poland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SAPHO Syndrome
- What is being tested?
- Etanercept
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 4 Sep 2024to 18 Oct 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Centrum Wsparcia Badań Klinicznych
Warsaw, Masovian Voivodeship, 02-637
Marta Kurek, 603 315 033 ext. +48, marta.kurek@spartanska.pl
Agnieszka Kurowska, 691 326 114 ext. +48, agnieszka.kurowska@spartanska.pl
About this study
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
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.
- Conditions
- SAPHO Syndrome
- Being tested
- Etanercept, Placebo
- Medical subject headings
- Acquired Hyperostosis Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtanerceptDrug
treatment with etanercept in addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs
PlaceboDrug
treatment with placebo in addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs
| Study group | Role | What they receive |
|---|---|---|
| Etanercept | Experimental | treatment with etanercept in addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs Receives: Drug: Etanercept |
| Placebo | Placebo comparator | treatment with placeboin addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks (day 85)
Secondary outcomes (16)
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.
Measured: after 4 and 8 weeks
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
Measured: after 4, 8 and 12 weeks
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
Measured: after 4, 8 and 12 weeks
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.
Measured: after 4, 8 and 12 weeks
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.
Measured: at 4, 8 and 12 week
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.
Measured: at Weeks 4, 8 and 12
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.
Measured: at Weeks 4, 8 and 12
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.
Measured: at 4, 8 and 12 weeks
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.
Measured: after 4, 8 and 12 weeks
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.
Measured: after 4, 8 and 12 weeks
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.
Measured: after 4, 8 and 12 weeks
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.
Measured: after 4, 8 and 12 weeks
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.
Measured: after 4, 8 and 12 weeks
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.
Measured: after 4, 8 and 12 weeks
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.
Measured: after 4, 8 and 12 weeks
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.
Measured: after 4, 8 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start4 Sep 2024
- Primary completion18 Oct 2028 (estimated)
- Study completion18 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SAPHO SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland
- Sponsor type
- Research network
- Collaborators
- Medical Research Agency, Poland
- Responsible party
- Sponsor
- Investigators
- Jakub Wroński, PhD, MD, Principal investigator, National Institute of Geriatrics, Rheumatology and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011889
- Sponsor's protocol ID
- NIGRIR_003SAPHO
- Acronym
- SAPHO
- Status last verified
- Apr 2026
- First submitted
- 28 Jul 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06011889
- Acronym / sponsor ID
- SAPHO / NIGRIR_003SAPHO
- Conditions
- SAPHO Syndrome
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Institute of Geriatrics, Rheumatology and Rehabilitation, PolandResearch network
- Collaborators
- Medical Research Agency, Poland
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- 18 Oct 2028 (estimated)
- Study completion
- 18 Oct 2028 (estimated)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etanercept | Experimental | Drug: Etanercepttreatment with etanercept in addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs |
| Placebo | Placebo comparator | Drug: Placebotreatment with placeboin addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Etanercepttreatment with etanercept in addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs | Drug | Etanercept |
| Placebotreatment with placebo in addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs | Drug | Placebo |
Primary outcome
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)
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.
16 secondary outcomes
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
decrease in the Bath Ankylosing Spondylitis Functional Index (BASFI) by a minimum of 50 percent
Time frame: after 4, 8 and 12 weeks
decrease in the Dermatology Life Quality Index (DLQI) by at least 50 percent from the result on the day of randomization
Time frame: after 4, 8 and 12 weeks
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
Time frame: after 4, 8 and 12 weeks
decrease in the Dermatology Life Quality Index (DLQI) by a minimum of 50 percent
Time frame: after 4, 8 and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
Related trials for SAPHO Syndrome
RecruitingObservational study
Study of the Pathophysiological Mechanisms Involved in the SAPHO Syndrome: Genetic Component and Immune Response
SAPHO Syndrome
RecruitingObservational study
Typological Study of Sleep Pathologies During Psoriatic Rheumatism and SAPHO Syndrome: Prospective Study Within the Paris Saint-Joseph Hospital Group"
Psoriasis Arthritis, SAPHO Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jakub Wroński, PhD, MD principal investigator
National Institute of Geriatrics, Rheumatology and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Etanercept in people with SAPHO Syndrome, run by National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jakub Wroński, PhD, MD (22 6880632 ext. +48, jakub.wronski@spartanska.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 12 weeks (day 85)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.