Rheumatoid Arthritis
Conditions
Interventions
Morning group:The time of taking methotrexate is in the morning (7:00-9:00)
Afternoon group:The time of taking methotrexate is in the afternoon (13:00~15:00)
Evening group:The time of taking methotrexate is at night (21:00~23:00)
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) The study subjects must meet the following diagnostic criteria: Western medicine diagnostic criteria: Comprehensive assessment using the 2010 ACR/EULAR classification criteria for rheumatoid arthritis. (2) Ages between 18 and 70 years. (3) Radiographic grading of both hands at level III or below. (4) Subjects must not have taken or orally ingested a stable dose of methotrexate (12.5 mg per week) for at least 4 weeks before screening and must maintain a stable dose throughout the entire study. (5) If the subject is treated with traditional disease relieving antirheumatic drugs (DMARDs), JAK enzyme inhibitors (including tofacitinib, baritinib), fusion protein based biologics (including etanercept, Qiangke, Anbino, Enbrel, etc.), monoclonal antibody based biologics (including adalimumab, infliximab, tocilizumab, etc.), they must have been treated with a stable dose for at least 2 weeks before enrollment. (6) If subjects take oral glucocorticoids, the dose must be stabilized to an equivalent of =10 mg/day prednisone for at least 4 weeks before enrollment. If already discontinued, oral glucocorticoids should be stopped at least 2 weeks before enrollment. (7) If subjects use nonsteroidal anti-inflammatory drugs (NSAIDs) or other analgesics to treat RA, the dose must have been stabilized for at least 2 weeks before enrollment. If not used, NSAIDs must have been discontinued for at least 2 weeks before enrollment. (8) Written informed consent to participate in this trial must be signed by the subject or their family member (guardian).
Exclusion criteria
Exclusion criteria: (1) Receipt of intra-articular, intramuscular, or intravenous glucocorticoid therapy, including adrenocorticotropic hormone therapy, within the 12 weeks prior to enrollment. (2) Pregnancy, breastfeeding, or plans for imminent pregnancy. (3) Severe diseases affecting vital organs such as the cardiovascular, cerebral, hepatic, pulmonary, renal, and hematopoietic systems, as well as acute or chronic infectious diseases, malignancies, and psychiatric disorders. (4) Other autoimmune diseases, excluding Sjögren's syndrome. (5) Active fibromyalgia that, in the investigator's opinion, would complicate the accurate assessment of rheumatoid arthritis activity in this study. (6) Intolerance to methotrexate tablets. (7) Laboratory screening with any of the following specific abnormalities: AST or ALT > 1.2 times the upper limit of normal; hemoglobin 1.6 times the upper limit of normal. (8) Abnormal 12-lead electrocardiogram (ECG) at screening, and the investigator or sponsor considers this abnormality clinically significant and likely to pose an unacceptable risk to the patient participating in this study. (9) Current participation in other trials or participation in another drug clinical trial within the past 2 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of adverse reaction ; | — |
Secondary
| Measure | Time frame |
|---|---|
| DAS28;ACR20;ESR;CRP;Health Assessment Questionnaire;TJC28;SJC28;Morning stiffness time;Rest pain score;X-ray for both hands; | — |
Countries
China
Contacts
Public ContactHuang Runyue
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed