ankylosing spondylitis
Conditions
Interventions
Treatment group: 6S-5-methyltetrahydrofolate calcium nutrition tablets, 0.8mg, QD
Control group:placebo,0.8mg,QD
Sponsors
Department of Clinic Genetics, Changzheng Hospital, Naval Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Subjects could fully understand the purpose, method and the possible adverse reactions of this experiment, voluntarily act as subjects, and voluntarily sign informed consent prior to the commencement of any research procedure; 2. Subjects who could communicate well with researchers, understand and comply with the requirements of the study 3. The age of subjects when sign the informed consent is greater than 18 years old , no gender preference; 4. Subject who was diagnosed with ankylosing spondylitis according to the revised New York Criteria for ankylosing spondylitis in 1984; 5. Have maintained a stable AS regimen of tumor necrosis factor-a inhibitor (TNFi) for at least 8 weeks prior to enrollment; 6. The folate metabolism gene polymorphisms MTHFRc.677C>T was CT or TT, with a baseline blood homocysteine level >=10 µmol .L-1; 7. Subjects without fertility potential (surgical sterilization such as hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks prior to screening); or women of reproductive age and their male partners, and male subjects with their female partners agreed to use an effective contraceptive regimen during the trial and for 3 months after the end of the last dose, no sperm donation program for male.
Exclusion criteria
Exclusion criteria: 1. Subjects with a history of allergic diseases or allergies (3 or more drug or food allergies); 2. Any of the laboratory tests at the time of screening or baseline examination meet the following criteria: liver function: AST/ALT/ Total bilirubin >3*ULN Creatinine clearance 60ml/min (Creatinine clearance= (140-age)×weight (kg)]/[0.0.818x creatinine(µmol/L),creatinine, for female, multiply the result by 0.85) Hemoglobin(male)<10.0g/dL(100.0g/L),or (female)<9.0g/dL(90.0g/L); WBC<3.0x10^9/L; Neutrophil count<1.5x10^9/L; PLT<90x10^9/L; 3. Subjects with active infection which require intravenous anti-infective therapy within 30 days prior to baseline or oral/intramuscular anti-infective therapy within 14 days prior to baseline; 4. Subjects with persistent or chronic infections (such as chronic pyelonephritis, bronchiectasis, or osteomyelitis) who have received oral anti-infective therapy within 14 days prior to baseline (excluding fungal infections of the nail bed), or those deemed unsuitable for participation in this study by the investigator; 5. Subjects with a history of thromboembolic events, including deep venous thrombosis, pulmonary embolism, arterial thrombosis, or those with high-risk factors for thromboembolism (subjects deemed unsuitable for participation in this study by the investigator based on clinical assessment); 6. Subjects with a history of any of the following cardiovascular diseases within 6 months prior to screening: moderate to severe congestive heart failure (New York Heart Association Class III or IV), cerebrovascular accident, or those who, in the opinion of the investigator, are unsuitable for participation in this study due to their current or past cardiovascular history. 7. Subjects with conditions that may interfere with drug absorption, including but not limited to short bowel syndrome, gastrectomy, or specific types of bariatric surgery (such as gastric bypass); subjects with a history of gastric banding/partitioning are not excluded; 8. A history of lymphoproliferative disease or the presence of symptoms or signs suggestive of lymphoproliferative disease; 9. A history of malignancy, excluding successfully treated non-melanoma skin cancer (NMSC) or localized cervical carcinoma in situ; 10. A history of organ transplantation; 11. A history of drug or alcohol abuse within 6 months prior to screening; 12. Presence of nodules or masses requiring close observation or unstable conditions within 6 months prior to screening (based on clinical assessment by a specialist); 13. Subjects who have undergone major surgery within 30 days prior to baseline or are expected to undergo any elective surgery within 12 weeks after the first drug administration in this study; 14. Subjects with clinically significant medical conditions that may affect their participation in this study or render them unsuitable as candidates to receive the investigational product, including but not limited to clinically significant cardiac, hepatic, neurologic, respiratory, hematologic, gastrointestinal, renal, or psychiatric diseases, or any other reasons; 15. Subjects who have participated in any other clinical trials (including drug and device trials) within 3 months prior to screening and have received investigational drugs or medical devices as interventions; 16. Subjects who are positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), syphilis antibody (TP-Ab), or human immunodeficiency virus (HIV) antibody; 17. Fem
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Homocysteine level; | — |
Secondary
| Measure | Time frame |
|---|---|
| metabolism index;Nutritional indicators;Immune cell level(TH1,TH2,TH17,TREG);Treatment emerged adverse event;Blood biochemistry;Blood routine index;ASAS20, ASAS40;BASFAI,BASDAI;ASQoL;Hamilton Depression Rating Scale; | — |
Countries
China
Contacts
Public ContactLiu Yaoyang
Department of Clinic Genetics, Changzheng Hospital, Naval Medical University
Outcome results
None listed