Ankylosing Spondylitis
Conditions
Interventions
Test group :Ivarmacitinib
Sponsors
Shanghai Changzheng Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. When signing the informed consent form, the age should be between 18 and 75 years old, with no gender restrictions; 2. Meet the diagnosis of active ankylosing spondylitis (AS), with radiological evidence documented, and meet the revised 1984 modified New York criteria for ankylosing spondylitis, or meet the 2009 ASAS criteria for axial spondyloarthritis (SpA); 3. During the screening period or baseline assessment, patients were required to have active AS (defined as BASDAI score >=4 and total back pain VAS score >=4); 4. It is proposed to use Imatinib Sulfate Tablets for treatment; 5. Volunteer to participate in the study and sign the informed consent form, understanding and willing to strictly adhere to the requirements of this clinical study protocol and complete the study; 6. Female subjects who are capable of bearing children must undergo a serum pregnancy test within 7 days before the first administration, and the test result must be negative. They must also not be breastfeeding and must agree to adopt effective contraceptive measures during the trial period and within 1 month after the last administration of Imatinib Sulfate Tablets. For male subjects whose partners are female subjects who are capable of bearing children, they must agree to adopt reliable contraceptive methods from the time they sign the informed consent form until within 1 month after the last administration of Imatinib Sulfate Tablets. During the same time period, male subjects must also agree not to donate sperm.
Exclusion criteria
Exclusion criteria: 1. Patients who have previously received a standardized course of treatment with JAK inhibitors (such as tofacitinib, upadacitinib, baricitinib, fegotinib, delamanid, etc., including topical preparations) for primary failure; 2. Patients diagnosed by researchers as currently experiencing active symptoms of primary fibromyalgia or other diseases affecting the assessment of AS symptoms; 3. Female subjects who are breastfeeding or pregnant, or fertile subjects who are unwilling to adopt effective contraceptive measures during the entire trial period and within 1 month after the last administration of Imatinib Mesilate Tablets; 4. Patients with uncontrollable infections, such as hepatitis B carriers with liver dysfunction (AST or ALT >= 3 times the upper limit of laboratory normal values, or bilirubin >= 1.5 times the upper limit of laboratory normal values); patients with a history of latent or active tuberculosis who have not undergone sufficient anti-tuberculosis treatment courses, etc; 5. Estimated glomerular filtration rate (eGFR) calculated using the Modification of Diet in Renal Disease (MDRD) formula or other methods is less than 60 mL/min/1.73 m^2; 6. Suffering from moderate to severe congestive heart failure (New York Heart Association Class III or IV), with a history of cardiovascular and cerebrovascular events leading to hospitalization within the previous 6 months, including but not limited to percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass surgery, cerebral hemorrhage, and subarachnoid hemorrhage; 7. Patients with malignant tumors or a history of malignant tumors (excluding fully treated or resected non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix); 8. Patients who have participated in other clinical trials within 30 days prior to the screening period; 9. Patients who refuse to sign the informed consent form, or are unwilling or unable to cooperate with the collection of medical history and clinical images; 10. Researchers believe that there are any other patients who are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The 40% improvement response standard established by the Assessment of SpondyloArthritis International Society (ASAS); | — |
Secondary
| Measure | Time frame |
|---|---|
| The 20% improvement response standard established by the Assessment of SpondyloArthritis International Society (ASAS);Night pain and total back pain VAS score;Bath Ankylosing Spondylitis Disease Activity Index (BASDAI);Bath Ankylosing Spondylitis Functional Index (BASDFI);Bath Ankylosing Spondylitis Metrology Index;Ankylosing Spondylitis Disease Activity Score (ASDAS);Madrid Ultrasound attachment point inflammation index (MASEI);Maastricht ankylosing spondylitis enthesitis score (MASES);Ankylosing spondylitis quality of life;physician global assessment (PGA);Patient Global Assessmen;C-reactiveprotein;Modified stoke ankylosing spondylitis spinal score (mSASSS);Erythrocyte sedimentation rate;Joint swelling count;Tender Joint Count; | — |
Countries
China
Contacts
Public ContactHuji Xu
Shanghai Changzheng Hospital
Outcome results
None listed