ankylosing spondylitis
Conditions
Interventions
group 1:Decrease the TNFi dose by 25% every 12 weeks to 50% of the original dose, and then reduce the dose to 33% of the original dose after another 12 weeks, and maintain the dose
group 2:Decrease TNFi dose by 25% every 12 weeks to 25% of the original dose, and maintain the dose
group 3:Decrease TNFi dose by 25% every 12 weeks to 25% of the original dose, and after another 12 weeks, the dose was reduced to 10% of the original dose, and the dose was maintained.
Sponsors
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. A male who is at least 18 years old or a female patient with AS who is not pregnant or breastfeeding. Women with childbearing potential are defined as all women who are physiologically capable of getting pregnant, unless effective contraceptive methods are used during the study period; 2. Treatment with TNFi alone in a sufficient amount, and the condition is stable for more than 3 months; 3. During the study period, drugs other than TNFi can not be used to treat AS; 4. Patients must discontinue DMARD 4 weeks before randomization, except for leflunomide, which must be discontinued 8 weeks before randomization, unless leflunomide has been cleaned by cholestyramine.
Exclusion criteria
Exclusion criteria: 1. The chest X-ray examination or MRI examination performed within 3 months before the screening is currently infected or has evidence of malignant disease, and has been evaluated by a qualified doctor; 2. Patients with complete rigidity of the spine; 3. Patients who are using strong opioid analgesics (for example, methadone, hydromorphone, morphine); 4. Have used any experimental drugs and/or devices 4 weeks before enrollment or 5 half-lives of experimental drugs (whichever is longer); 5. Have a history of allergic reactions to research drugs or their excipients or similar chemically classified drugs; 6. Any intra-articular injection therapy (for example, corticosteroids) has been performed within 4 weeks before enrollment; 7. Any intramuscular injection of corticosteroids in the 2 weeks before enrollment; 8. Have previously received any cell depletion therapy, including (but not limited to) anti-CD20 antibodies; 9. Chinese medicine was used to treat AS within 4 weeks before enrollment; 10. Women during pregnancy or lactation, where pregnancy is defined as the state of a woman after conception until the end of pregnancy, which is confirmed by a positive hCG laboratory test; 11. Have received IL-17 inhibitors treatment before; 12. Currently suffering from other active inflammatory diseases other than AS that may confuse the efficacy evaluation, including inflammatory bowel disease or uveitis; 13. There are potential basal metabolism, blood, kidney, liver, lung, nerve, endocrine, heart, infectious or gastrointestinal diseases, and the researcher believes that such diseases will reduce the patient's immune function and/or use immunomodulators will put the patient at an unacceptable risk during treatment; 14. Obvious health problems or diseases, including (but not limited to) the following conditions: poorly controlled hypertension (>= 160/95 mmHg), congestive heart failure (New York Heart Association standard level III or IV), Poorly controlled diabetes or extremely poor functional status that makes them unable to take care of themselves; 15. A history of clinically significant liver disease or liver damage, as indicated by abnormal liver function tests (more than 2 times the upper limit of normal); 16. With a history of kidney injury, glomerulonephritis, or the patient has only one kidney, or the serum creatinine level exceeds 1.5 mg/dl (132.6 µmol/L); 17. The total number of white blood cells during screening < 3,000/µl, or platelets <100,000/µl or neutrophils <1,500/µl or hemoglobin <8.5 g/dl (85 g/L); 18. Active systemic infection occurred within 2 weeks before screening; 19. Currently being infected or suffering from chronic, recurrent, or infectious diseases, or having a positive result of purified protein derivative (PPD) skin test or evidence of tuberculosis infection as indicated by a positive result of QT-SPOT test; 20. Known to be infected with HIV, hepatitis B or hepatitis C at the time of screening; 21. There is a history of lymphoproliferative disease or any known malignant tumor in the past 5 years, or a history of malignant tumor of any organ system (basal cell carcinoma or actinic keratosis that has been treated and has no evidence of recurrence in the past 3 months Disease, cervical carcinoma in situ or non-invasive malignant colon polyps that have been removed); 22. The clinical investigator judges that the patient has a severely progressive or poorly controlled disease and is not suitable for parti
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the Assessment of SpondyloArthritis international Society;Overall disease activity assessment (Visual Analogue Scale);Back pain intensity assessment (Visual Analogue Scale);Bath Ankylosing Spondylitis Functional Index;Bath Ankylosing Spondylitis Disease Activity Index;bath ankylosing spondylitis metrology index;Maastricht Ankylosing Spondylitis Enthesitis Score;erythrocyte sedimentation Rate;hypersensitive C-reactive protein; | — |
Secondary
| Measure | Time frame |
|---|---|
| the medical outcomes study item short from health survey, SF-36;Ankylosing Spondylitis Quality of Life Scale;The Functional Assessment of Chronic Illness Therapy-Fatigue;EuroQol five dimensions questionnaire;Work Productivity And Activity Impairment Questionaire, General Healthversion; | — |
Countries
China
Contacts
Public ContactDong Lingli
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed