Ankylosing spondylitis
Conditions
Interventions
Experimental group:Recombinant anti-tumor necrosis factor-a whole human monoclonal antibody injection, 40mg/0.8mL, subcutaneous injection every two weeks
Control group:Humira, 40mg/0.8mL, subcutaneous injection every two weeks
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Voluntary signing of informed consent, able to comply with the program and have the ability to carry out relevant procedures 2. Aged 18 to 65 years (The date of signing the informed consent shall prevail); 3. The body mass index (BMI) is between 20 and 28 kg/m2 (including 20 kg/m2 and 28 kg/m2), and the body weight is between 50 and 85 kg (including 50 kg and 85 kg); 4. According to the New York standard for ankylosing spondylitis revised in 1984, the diagnosis of ankylosing spondylitis; 5. Patients diagnosed with active ankylosing spondylitis (AS) during the screening and baseline periods; defined as at least 2 of the following: 1) BASDAI score >= 4; 2) In the assessment of pain visual analog scale (VAS), the total back pain VAS >= 4cm; 3) Morning stiffness time >= 1 hour; 6. >= 1 non-steroidal anti-inflammatory drugs (NSAIDs), or >= 1 remission of anti-rheumatic drugs (DMARDs) for treatment >= 4 weeks, but ineffective or intolerant; 7. Women of childbearing age are negative for human chorionic gonadotropin (HCG) at screening and baseline. Non-fertility women (women who have undergone hysterectomy or bilateral oophorectomy), or menopausal (defined as no menstruation in the past 5 years), are exempt from this requirement; 8. Women of childbearing age and male subjects agree and undertake to use effective contraceptive measures throughout the trial period (from the signing of informed consent to the last visit) and at least 20 weeks after the last trial drug administration.
Exclusion criteria
Exclusion criteria: 1. The spine is completely stiff (fused); 2. Those who have undergone spinal surgery or joint surgery within 24 weeks before randomization; 3. Anyone who is allergic to any test drug ingredient; 4. Previously used TNF antagonists to treat AS, and ineffective or intolerant; 5. Inhibition of other TNF-a including TNF antagonists within 12 weeks prior to randomization Agents or other biological agents such as etanercept, infliximab and adamu monoclonal antibody, etc.; chemical drugs such as thalidomide; 6. Anti-drug antibodies (HAHAs) are positive in laboratory results; 7. Those who have used DMARDs in the first 8 weeks of randomization (except MTX and SSZ); 8. Anyone who has used any immunomodulatory agents within the first 8 weeks of randomization; 9. In the first 4 weeks of randomization, take sulfasalazine (SSZ) > 2g / day, or methotrexate (MTX) > 15mg / week; 10. In the first 4 weeks of randomization, although the dose of sulfasalazine (SSZ) 140mmHg, or screening period diastolic blood pressure > 90mmHg); 2) Myocardial infarction occurred within 12 months prior to the signing of the informed consent form; 3) Unstable angina; 4) Congestive heart failure; 5) Severe lung disease requiring hospitalization or oxygen therapy, chronic bronchitis, obstructive pulmonary disease; 6) Uncontrolled diabetes; 7) Any inflammatory or immune disease other than AS, including but not limited to immunodeficiency syndromes such as Felty syndrome; rheumatoid arthritis; systemic lupus erythematosus; scleroderma or polymyositis; with ankylosing spondylitis Unstable clinical manifestations, such as psoriasis, uveitis, ulcerative colitis, etc.; multiple sclerosis or other central demyelinating diseases; primary dryness syndrome. 8) Combined with chronic liver disease; 9) History of cancer or cancer (except for excised skin basal cell carcinoma or squamous cell carcinoma); 10) Open skin ulcers; 11) Infection within 4 weeks prior to the signing of the informed consent form, and anti-infective treatment is required; 12) Have a history of active tuberculosis or tuberculosis, or chest X-ray examination suggesting previous tuberculosis, or positive gamma interferon release test; 13) Any one of human immunodeficiency virus (HIV) antibodies, Treponema pallidum antibodies, and hepatitis C virus antibodies should be excluded. Hepatitis B surface antigen positive need to be excluded; hepatitis B surface antigen is negative, but hepatitis B core antibody positive and hepatitis B virus DNA detection result is greater than or equal to the hospital reference value upper limit, need to be excluded; 18. Those with abnormal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects who achieved ASAS 20 response at 24 weeks;; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects who achieved ASAS 20 response at 12 weeks;;Percentage of subjects who achieved ASAS 40 response at 12 weeks and 24 weeks;;Percentage of subjects who achieved a BASDAI 50 response at 12 weeks and 24 weeks;;The proportion of subjects achieving ASAS 5/6 improvement at 12 weeks and 24 weeks;;Morning stiffness at 12 and 24 weeks (average of BASDAI questions 5 and 6).;Improvements in CRP and ESR at 12 and 24 weeks;Improvements in the ankylosing spondylitis disease activity score (ASDAS) at 12 and 24 weeks;;Improvement in swollen joint counts (46 joints) at 12 weeks and 24 weeks;;Improvement in tender joint count (46 joints) at 12 weeks and 24 weeks;;Improvements in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score at 12 and 24 weeks;;Improvement of the linear Bath Ankylosing Spondylitis Index (BASMIlin) score at 12 and 24 weeks;Improvement in thoracic dilatation at 12 and 24 weeks;;Maastricht ankylosing spondylitis tendonitis score (MASES) improvement at 12 weeks and 24 weeks;;Improvement in overall evaluation of doctors with disease activity at 12 weeks and 24 weeks;;Improvement in overall evaluation of subjects with disease activity at 12 weeks and 24 weeks;;Improvement in overall pain assessment of subjects at 12 and 24 weeks;;Improvement of painful VAS at night for 12 weeks and 24 weeks;;Improvement of total back pain VAS at 12 weeks and 24 weeks;;Improvement in overall score (BAS-G) of subjects with Abdominal Spondylitis at 12 weeks and 24 weeks;;Improvements in the Bath Ankylosing Spondylitis Function Index (BASFI) at 12 and 24 weeks;;Improvement of the 12-week and 24-week ankylosing spondylitis health assessment questionnaire (HAQ-S);;Improvement of the SF-36V2 Health Questionnaire (SF-36) at 12 weeks and 24 weeks;;The safety of all subjects who will be administered at least once will be assessed and the following variables will be assessed: symptoms, physique, vital signs, laboratory tests, electrocardiograms, and adverse | — |
Countries
China
Contacts
Public ContactXiaofeng Zeng
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed