Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:24 PM
Ignite Modification Date:
2025-12-24 @ 2:24 PM
NCT ID:
NCT02544659
Eligibility Criteria:
Inclusion Criteria:
1. Male and female patients between the ages of 18 and 70 years
2. Only 1 of the 4 inclusion criteria is sufficient to arrive at a diagnosis of SAPHO syndrome：
* Osteo-articular manifestations of acne conglobata, acne fulminans, or hidradenitis suppurativa
* Osteo-articular manifestations of PPP
* Hyperostosis (of the anterior chest wall, limbs or spine) with or without dermatosis
* CRMO involving the axial or peripheral skeleton with or without dermatosis Palmoplantar pustulosis(PPP); chronic recurrent multifocal osteomyelitis(CRMO)
3. MRI shows bone marrow edema in affected site in patients
4. Blood serum of patients show the normal white blood cell count, liver and renal function
5. Patients who like to be followed up for 1 years
6. Other protocol defined inclusion criteria may apply
Exclusion Criteria:
1. Women in pregnancy or lactation.
2. Septic osteomyelitis
3. Infectious chest wall arthritis
4. Infections PPP
5. Palmo-plantar keratodermia
6. DISH except for fortuitous association
7. Osteoarticular manifestations of retinoid therapy
8. Other protocol defined exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02544659
Study Brief:
Protocol Section:
NCT02544659