Ankylosing Spondylitis
Conditions
Interventions
BAT1406:BAT1406, 40mg/0.8ml/box, subcutaneous insulin
Humira:Humira, 40mg/0.8ml/box, subcutaneous insulin
Sponsors
The Third Affiliated Hospital, Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
16 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Must be between 16-65 years old (inclusive) at the time of signing the ICF; male or female. 2. Subjects must meet the diagnostic criteria for AS (AS New York standard revised in 1984) by providing pelvic X-rays taken within six months prior to enrollment. 3. Subjects suffer from active AS during screening. Active AS is defined as: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >=4, spinal pain >=4. 4. Subjects' liver and kidney function indicators should meet the following requirements during screening: (1) Serum creatinine (Cr) 75 mL/min; (2) Alanine Transaminase (ALT) =8.0 g/dL; (2) White blood cell count >=3.5x10^9/L; (3) Neutrophil count >=1.5x10^9/L; (4) Platelet count >=100x10^9/L; 6. Prior to screening, subjects were allowed to use stable doses of MTX (<=25 mg/week), sulfasalazine (< 3 g/day), NSAIDs, and/or analgesics, but the doses should have been stabled for at least 4 weeks prior to screening, and must remain unchanged during the trial; 7. Prior to screening, subjects were allowed to use glucocorticoids, but are limited to daily oral doses of prednisone of <=10 mg or equivalent. Doses should have been stable for at least 4 weeks prior to screening, and should remain unchanged during the trial. In addition, subjects were permitted to use topical/ophthalmic/otic medications containing low potency glucocorticoids according to product monographs; 8. Subjects discontinuing leflunomide should have been treated with cholestyramine (8 grams each time, t.i.d) for 11 days, and there should have been a 4-week washout period from the first dose of cholestyramine. For subjects discontinuing leflunomide and not treated with cholestyramine, a 12-week washout period from the last dose of leflunomide to the screening period was required; 9. During screening, if the subjects were using botanical preparations (such as Tripterygium Wilfordii, total glucosides of paeony, sinomenine, yishen juanbi pill, etc.) for the treatment of AS, or thalidomide, or were treated with physical therapy, they should have stopped these medications and treatments for at least 4 weeks before being considered eligible candidates; 10. During screening, if the subjects had previously received live (attenuated) virus/bacterial vaccines, or had received intravenous injection of immunoglobulin IgG, they must have stopped the medications for at least 12 weeks before being considered eligible for enrollment; 11. Women of childbearing age must have had a negative serum and/or urine pregnancy test prior to enrollment, and must not have been breastfeeding; 12. Subjects of childbearing age (regardless of gender) must have voluntarily agreed to use reliable contraceptive methods (except for non-fertile women and men who have undergone vasectomy) from signing of the ICF to 6 months after the last dose of treatment. Contraceptive methods include but are not limited to: hormonal contraception, physical contraception, or abstinence; Note: During screening, women who have entered menopause for less than 12 continuous months or men who have undergone vasectomy within 6 months should use reliable contraception methods. 13. Subjects should have the ability to understand the nature and purpose of the trial, including possible risks and side eff
Exclusion criteria
Exclusion criteria: 1. Subjects have used any biological products to treat AS within 6 months prior to the enrollment. 2. Clinical or imaging studies suggested that the spine has reached complete rigidity (if there were two consecutive lumbar vertebrae not fused together, then the spine has not reached complete rigidity). 3. Allergic to any ingredients of Humira, allergic to human proteins or susceptible to immunoglobulin allergies. 4. Subjects with a medical history of hepatitis B, hepatitis C, HIV, any immunodeficiency, or with a positive laboratory test result (hepatitis B surface antigen, hepatitis C antibody, or HIV antibody) during screening; 5. Subjects diagnosed with active pulmonary tuberculosis, latent tuberculosis infection, or subjects suspected of tuberculosis based on clinical manifestations (including but not limited to pulmonary tuberculosis); 6. Subjects with positive T.SPOT.TB test or abnormalities in tuberculosis-related chest X-ray; or subjects with TB who have not received standard treatment of at least 30 days; 7. Active infections, including acute and chronic infections, and local infections (such as sepsis, abscesses, opportunistic infections, and invasive fungal infections); 8. Subjects who have taken oral antibiotics within 2 weeks prior to the screening or have been given intramuscular/intravenous treatments for infection within 4 weeks prior to the screening, or have had severe infections within 6 months prior to the screening (investigators must determine the potential risks of subjects' enrollment based on the individual's clinical history); 9. Subjects with a history of recurrent herpes zoster, history of Listeria infection, reticuloendotheliosis, and other chronic or recurrent infections; 10. Subjects who have undergone ostectomy/arthrectomy/synovectomy within 3 months prior to the screening, or planned to undergo joint or spinal surgery during the trial; 11. Subjects with clinically significant laboratory abnormalities that suggested the presence of unknown disease and required further clinical examination; 12. Subjects with an apparent history of drug abuse or alcohol dependence at present or in the past 2 years; 13. Subjects with one or more of the following diseases: (1) Subjects without self-care ability, those who require wheelchairs or those who are bedridden; (2) Uncontrolled hypertension (defined as systolic pressure >150 mmHg, or diastolic pressure >100 mmHg during the screening period); (3) Subjects with a history of congestive heart failure (New York Heart Association classification III/IV); (4) Subjects with a history of acute myocardial infarction or unstable angina within 12 months prior to the screening; (5) Subjects with serious arrhythmias; (6) Any subject with clinically significant respiratory diseases, including but not limited to chronic obstructive pulmonary disease, asthma, interstitial lung disease, bronchiectasis, and pleural effusion; (7) Subjects with a history of demyelinating diseases or with symptoms suggestive of such diseases, including but not limited to: multiple sclerosis and Guillain-Barré syndrome; (8) Subjects who had not used a stable dose of medication to control diabetes within 4 weeks prior to the screening (glycated hemoglobin HbA1c >7% during screening); (9) Subjects with any arthritis or rheumatic diseases (in addition to AS) that may affect the evaluation of the clinical study, including but not limited to: rheumatoid arthritis, osteoarthritis, psoriatic art
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of subjects achieving the Assessment in SpondyloArthritis international Society (ASAS) 20 treatment response at week 12; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects achieving ASAS20 treatment response at week 24;Percentage of subjects achieving ASAS40 treatment response at week 12 and week 24;Percentage of subjects achieving ASAS5/6 treatment response at week 12 and week 24;Percentage of subjects achieving BASDAI50 treatment response at week 12 and week 24;Change of the performance status score at week 12 and week 24 compared with baseline;Change of the spinal pain score at week 12 and week 24 compared with baseline;Change of morning stiffness duration at week 12 and week 24 compared with baseline;Change of ASDAS at week 12 and week 24 compared with baseline;Change of BASDAI at week 12 and week 24 compared with baseline;Change of BASFI at week 12 and week 24 compared with baseline;Change of BASMI at week 12 and week 24 compared with baseline;Change of SF-36 at week 12 and week 24 compared with baseline;Change of EQ-5D at week 12 and week 24 compared with baseline;Change of chest expansion at week 12 and week 24 compared with baseline;Change of MASES at week 12 and week 24 compared with baseline;Change of swollen and tender joint counts at week 12 and week 24 compared with baseline; | — |
Countries
China
Contacts
Public ContactJieruo Gu
Outcome results
None listed