ankylosing spondylitis
Conditions
Interventions
Sponsors
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntary signing of informed consent, able to comply with the program and have the ability and wishes to carry out relevant procedures and limitations; 2. Aged >= 18 years at the time of signing the ICF, male or female; 3. Non-fertility women. Women of childbearing age agree and undertake to use effective contraceptive measures in 44 weeks; 4. Male subjects must use effective contraceptive measures in 24 weeks; 5. Diagnosed with ankylosing spondylitis according to the New York standard for ankylosing spondylitis revised in 1984; 6. Subjects suffer from active AS during screening (BASDAI >= 4, or ASDAS >= 2.1); 7. Prior to screening, subjects were allowed to use NSAIDS or glucocorticoids, but doses should have been stable for at least 4 weeks prior to screening, and should remain unchanged during the trial. The doses of glucocorticoids are limited to daily oral doses of prednisone of =85 g/L; White blood cell count >= 3.0 x 10^9/L; Neutrophil count >= 1.5 x 10^9/L; Platelet count >= 100 x 10^3/uL; Serum creatinine (Cr) <= 1.5 ULN; lanine Transaminase (ALT) <= 1.5 ULN; Aspartate Transaminase (AST) <= 1.5 ULN; Alkaline phosphatase (ALP) <= 1.5 ULN; serum bilirubin <= 1.5 ULN; 10. Prior to screening, subjects were allowed to use MTX (<= 25 mg/week), or sulfasalazine (<= 3 g/day), but it should be used for at least 3 months. The doses should have been stabled for at least 4 weeks prior to screening, and must remain unchanged during the trial; 11. During screening, if the subjects were using DMARDs (except MTX or sulfasalazine) for the treatment of AS, they should have stopped these medications and treatments for at least 4 weeks before being considered eligible candidates. If the subjects were using leflunomide, the treatment should be stopped for more than 8 weeks from the last time of leflunomide to the screening period, or washed out with cholestyramine was required.
Exclusion criteria
Exclusion criteria: Subjects with one or more of the following criteria were excluded: 1. Subjects with a history of poorly controlled active inflammatory diseases other than AS, including but not limited to: psoriatic arthritis, reactive arthritis, Juvenile idiopathic arthritis, systemic lupus erythematosus, autoimmune hepatitis; 2. Allergic to any component or ingredients of biological agents in this trial, allergic to human proteins or susceptible to immunoglobulin allergies; 3. Allergic to any ingredients of TNFa inhibitors and IL-17 inhibitors; 4. Subjects with active tuberculosis or mycobacterium tuberculosis infection, viral hepatitis, or with a positive laboratory test result (syphilis test or HIV antibody); 5. Subjects who have active infections within 1month prior to the screening, including acute and chronic infections, and local infections, such as septicemia, abscesses, cellulitis and opportunistic fungi infections (e.g., Candida); 6. Subjects who have undergone major surgery (including arthrectomy) within 3 months prior to initial administration, or planned to undergo surgery during the trial; 7. Subjects who are unable or unwilling to undergo an MRI scan (e.g., subjects with pacemakers, aneurysm clips, or metal fragments/foreign objects in their eyes, skin, or body that are unsuitable for MRI); 8. Subjects who had received live vaccine or attenuated vaccine 2 months before screening, or planned to receive live vaccine or attenuated vaccine during the trial. Subjects who received COVID-19 vaccine within 1 week before medication; 9. Subjects who are lactating or pregnant. Women who have planned to give birth within one year; 10. History of lymphoma or lymphoproliferative diseases. 11. Subjects who are using or have a history of the following concomitant drugs: (1) Subjects who did not have stable dose( which means that the dose did not change during medication) of MTX or sulfasalazine within 4 weeks prior to the screening, or other DMARDs; (2) Subjects who used DMARDs, other than methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine, 4 weeks before screening to the entire study period; (3) Leflunomide treatment had been given for 8 weeks prior to screening , unless washed out with cholestyramine was performed; (4) Subjects who had used tripterygium wilfordii, total glycosides of paeony and other Chinese patent medicine, or traditional Chinese medicine preparations within 4 weeks prior to the screening; (5) Injected corticosteroids into the muscle, vein, or joint cavity within 4 weeks prior to screening. Or injected hyaluronic acid (such as sodium hyaluronate injection) into joint cavity within 8 weeks prior to screening; (6) Subjects who had taken strong opioid analgesics (such as methadone, hydromorphone, or morphine) within 2 weeks prior to screening; (7) Subjects who are using or has a history of TNF-a inhibitors, IL-17 inhibitors, or janus kinase (JAK) inhibitors (e.g. tofacitib, upatinib).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| modified stoke ankylosing spondylitis spine score (mSASSS); SPondyloArthritis Research Consortium of Canada (SPARCC) MRI Score;Berlin Score;Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score;The ASAS40 response rate;The ASAS20 response rate;Ankylosing Spondylitis Disease Activity (ASDAS) Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient global assessment of disease activity (PGA);Physician global assessment of disease activity (PhGA);security; | — |
Countries
China
Contacts
Public ContactLingli Dong
Department of Rheumatology and Immunology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed