Synovitis, acne, pustulosis, hyperostosis, and osteitis syndrome
Conditions
Interventions
Secukinumab treatment group:Secukinumab 150mg subcutaneous once weekly for 4 weeks (at baseline, Weeks 1, 2, 3, and 4) and every 4 weeks thereafter up to Week 16
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–70 years; 2. In accordance with the diagnostic criteria of SAPHO reported by Kahn in 2003; 3. Palmoplantar pustolosis; 4. ASDAS-CRP>=1.3; 5. BASDAI>=4; 6. VAS>=4; 7. Inadequate response to the maximum doses of NSAIDs that were associated with an acceptable side-effects profile; 8. Patients who are regularly taking NSAIDs as part of their treatment are required to be on a stable dose for at least 2 weeks before randomization; 9. Patients who have been on a TNFa inhibitor (not more than one) must have experienced an inadequate response to an approved dose for 3 months or more or had unacceptable side effects.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. With a desire to have children during the study and 16 weeks after stopping treatment; 3. Evidence of previous or ongoing malignant tumor; 4. Evidence of active infection within 2 weeks before randomization; 5. Evidence of active tuberculosis infection; 6. Infection with HIV, hepatitis B or hepatitis C; 7. cardiac, hepatic, and renal dysfunction; 8. Concomitant inflammatory diseases that might confound the efficacy evaluation of secukinumab, such as inflammatory bowel disease, etc.; 9. cDMARDs treatment within 3 months before randomization; 10. Previous treatment of biological agent other than TNF-alpha inhibitor; 11. Plans for administration of live vaccines during the study or 6 weeks before the randomization; 12. Previous treatment with any cell-depleting therapies including but not limited to anti- CD20, CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in ASDAS; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients achieving ASDAS2.1, ASDAS1.3, ASDAS-CII, ASDAS-MI;The proportion of patients achieving VAS50;The proportion of patients achieving BASDAI50;Change from baseline in global bone pain;Change from baseline in BASDAI;The proportion of patients achieving PPPASI50/75/90;The proportion of patients achieving PASI50/75/90;The proportion of patients achieving treatment success in acne;Change from baseline in PPPASI, PASI, PGA, IGA; | — |
Countries
China
Contacts
Public ContactChen Li
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Outcome results
None listed