Arthritis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Suspected RA group: Patients with similar clinical manifestations of RA, who do not meet the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria (ACR/EULA) criteria for RA classification, and who were seronegative for RF and anti-CCP and excluded other diseases that could cause joint symptoms. (2) RA group: Patients with a clear diagnosis of RA, all of whom meet the 2010 ACR/EULAR classification criteria for RA. (3) SpA group: Patients with clearly diagnosed inflammatory arthritis, all of whom meet the criteria of the 2010 International Society for the Assessment of Spondyloarthritis (ASAS) classification for medial spondyloarthritis (SpA) or the 2011 International Society for the Assessment of Spondyloarthritis (ASAS) classification for peripheral spondyloarthritis (SpA), including ankylosing spondylitis, undifferentiated spondyloarthritis arthritis, psoriatic arthritis, etc. (4) OA group: patients with clearly diagnosed non-inflammatory arthritis, all of whom meet the diagnostic criteria for osteoarthritis of the knee (OA) established by the 2010 Chinese Medical Association Orthopaedic Branch Guidelines for the Diagnosis and Treatment of Osteoarthritis. (5) Control group: patients with sports injuries, trauma or rheumatic cold arthralgia who require or have the desire to undergo local ultrastructural treatment of the joint.
Exclusion criteria
Exclusion criteria: 1) Before signing the informed consent form, Subjects have been treated with donafenib; 2) Pathologically diagnosed hepatocellular carcinoma-intrahepatic cholangiocarcinoma (HCC-ICC); 3) Proven allergy to donafinil toluenlate and / or its excipients; 4) Patients with known active bleeding; 5) Patients with active gastrointestinal ulcer, bowel perforation or intestinal obstruction; 6) Uncontrolled hypertension and liver insufficiency; 7) Pregnant or lactating women; 8) Assessed by the investigator, Concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study; 9) Otherwise unsuitable by the investigator; note: the xclusion criteria item 3-7 are contraindications listed in the donafenib instructions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;DCR;ORR; | — |
Countries
China