Synovitis, Acne, Pustulosis, Hyperostosis, and Osteitis (SAPHO) syndrom
Conditions
Interventions
Treatment Group:Ivarmacitinib sulfate tablets
Sponsors
The First Affiliated Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female participants aged 18 to 75 years (inclusive). 2. Diagnosis of SAPHO syndrome according to the criteria proposed by Kahn et al. (1994). 3. Voluntary participation with the ability to provide written informed consent prior to the initiation of any study procedures, and expected to demonstrate adequate compliance with study requirements.
Exclusion criteria
Exclusion criteria: 1. Failure to meet any of the inclusion criteria. 2. History or presence of severe disease or significant impairment of vital organs, including but not limited to the heart, liver, or kidneys. Severity is defined as follows: a. Congestive heart failure classified as Killip class III or higher; b. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >= 4 times the upper limit of normal; c. Creatinine clearance < 25 mL/min. 3. Presence of immunodeficiency, uncontrolled severe infections, active or recurrent gastrointestinal ulcers, or psychiatric disorders. 4. Known hypersensitivity or allergic reactions to the investigational product. 5. Current active hepatitis or a history of severe liver disease. Hepatitis B: Patients who are HBsAg-positive will be excluded. Patients who are HBsAg-negative but anti-HBc-positive must undergo HBV DNA testing. Individuals with detectable HBV DNA will be excluded, while those with undetectable HBV DNA may be enrolled. Hepatitis C: Patients with a positive hepatitis C antibody will be excluded. 6. Pregnant or lactating women, and male or female participants planning to conceive within 12 months of study entry. 7. Any individual presenting clinical signs or symptoms consistent with adverse reactions listed in the Ivarmacitinib Sulfate Tablets package insert, or otherwise judged by the investigator to be unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| erythrocyte sedimentation rate;C-reactive protein;Global Assessment;Physician Global Assessment;Pain Visual Analog Scale;Health Assessment Questionnaire;Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F);36-Item Short Form Health Survey (SF-36);serum cytokine concentrations;imaging findings of affected joints (ultrasound or magnetic resonance imaging);the number and total area of skin lesions; | — |
Secondary
| Measure | Time frame |
|---|---|
| incidence and severity of all adverse events (AEs), serious adverse events (SAEs), and treatment-related AEs; | — |
Countries
China
Contacts
Public ContactBo Zou
The First Affiliated Hospital of China Medical University
Outcome results
None listed