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 >= 18years 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 throughout the trial period; 4. Male subjects must use effective contraceptive measures throughout the trial period; 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 >=3.0×109/L; Neutrophil count >=1.5x10^9/L; Platelet count >=100×103/µL; 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 have undergone major surgery (including spinal or joint surgery) within 3 months prior to the screening, or planned to undergo surgery during the trial; 10. Subjects who are lactating or pregnant. Women who have planned to give birth within one year; 11. History of lymphoma or lymphoproliferative diseases. 12. 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 TNFa inhibitors, IL-17 inhibitors, or janus kinase (JAK) inhibitors (e.g. tofacitib, upatinib).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence rate;Change of the radiographic performance at week 48, 72 and week 96 compared with baseline;Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score;The ASAS40 response rate;The ASAS20 response rate;Ankylosing Spondylitis Disease Activity (ASDAS) Score;Short Form-36 Health Survey (SF-36) Score;Patient global assessment of disease activity(PGA);Physician global assessment of disease activity(PhGA);Ankylosing Spondylitis Quality of Life Scale(ASQoL);Bath Ankylosing Spondylitis Functional Index (BASFI) Score;SPARCC MRI Score;mSASSS Score;SSS Score;Berlin Score ; | — |
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