Spondyloarthritis (SpA) is a chronic inflammatory disease mainly involving the spine, joint ligaments and tendons. It is characterized by inflammation of axial joints (especially sacroiliac joints) and involvement of asymmetric large joints of lower limbs. It is often accompanied by finger/toe inflammation (sausage finger/toe) and attachment inflammation (inflammation of the bone attachment of lig
Conditions
Interventions
Observation group:None
Sponsors
The Seventh Affiliated Hospital Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years at the time of signing the informed consent, regardless of gender; 2. Patients with a clear diagnosis of spondyloarthritis (excluding psoriatic arthritis) and eligible for biologics treatment after evaluation. 3. Subject voluntarily signed informed consent before the start of any procedures related to the study, able to communicate smoothly with the investigator, understand and be willing to strictly comply with the requirements of this clinical study protocol to complete the study.
Exclusion criteria
Exclusion criteria: 1. Those who have severe hypersensitivity reaction to the active ingredient of phnakizumab or any excipient; 2. Females of childbearing potential (defined as all females with the physiological conditions required for pregnancy) and males who are pregnant or unwilling or unable to take highly effective birth control measures during the study period and within 20 weeks after the last dose of study drug; 3. Active infection of great clinical significance; 4. Patients with moderate to severe heart failure (NYHA grade III/IV.); 5. Patients with malignant tumors who are receiving treatment or not receiving treatment; 6. Concomitant with other inflammatory diseases or severe autoimmune diseases, including but not limited to: inflammatory bowel disease, which may affect the efficacy and safety evaluation as judged by the investigator; 7. Any other condition that, in the opinion of the investigator, would prevent the subject from following and completing the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ASAS40; | — |
Secondary
| Measure | Time frame |
|---|---|
| ASAS20;BASDAI;BASFI; | — |
Countries
China
Contacts
Public ContactJieruo Gu
The Seventh Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed