Rheumatoid arthritis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: ? Patients with moderate to low disease activity according to DAS28-CRP score (2.6 < DAS28-CRP=5.1); ? aged from 18 to 70 years old; ? in accordance with the indications of biological agents adalimumab; ? If the subject is taking oral glucocorticoids, the dose must have been stabilized to a dose equivalent to less than 10mg of prednisone per day for at least 4 weeks before enrollment; If discontinued, oral glucocorticoids were discontinued at least 2 weeks before enrollment. ? the person who signed the informed consent form.
Exclusion criteria
Exclusion criteria: ?Pregnant, lactating women, or those planning to become pregnant during the study cycle; ?Combined with other AIDs history, such as systemic lupus erythematosus, vasculitis; ?Patients with severe primary diseases of respiratory system and circulatory system, which could not be controlled by conventional drugs; Patients with a history of severe infection, tuberculosis, hepatitis and other infectious diseases, lymphocytosis, hematopoietic system abnormalities, and tumors; Patients with severe water, electrolyte and acid-base balance disorders; Patients with primary or secondary immunodeficiency or hypersensitivity; Patients with severe mental illness. Or patients with one of the following clinical measures: alanine aminotransferase or aspartate aminotransferase elevations > 3 times the upper limit of normal; Increased creatinine > 1.5 times the upper limit of normal; HIV serological test was positive; Any one of the main indicators of blood routine test was lower than the lower limit of normal value; Or other laboratory abnormalities judged by the investigator to be inappropriate for participation in the trial; ?Patients who are known to be allergic to the drugs used in the study or those with related drug components; ?Those who are participating in other drug clinical trials or have participated in other clinical trials within 4 weeks; ?Use of Chinese medicine or Chinese patent medicine, local therapy (hormone external medicine, etc.) within 2 weeks; Patients treated with oral systemic therapy (methotrexate, sulfasalazine, azathioprine, hydroxychloroquine, iguratimod, cyclosporine, mycophenolate mofetil, tacrolimus, etc.) except leflunomide within 4 weeks; Leflunomide used within 12 weeks (although leflunomide would need to be stopped at least 4 weeks before starting study treatment if standard cholestyramine washout was received for 11 days); Treatment with 5 biological agents within the half-life (etanercept 17.5 days, infliximab 50 days, adalimumab 70 days, etc.); ?Patients who had received interferon therapy within 4 weeks before enrollment or were expected to need interferon therapy during the study; Persons who received a live vaccine within 2 weeks before enrollment or who required a live vaccine during the trial; ?Patients with active gastroduodenal ulcer or gastritis caused by long-term use of non-steroidal anti-inflammatory drugs; ?Patients deemed by the investigator to be ineligible for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| The interval between the first recurrence;DAS28-CRP;DFR;X-ray examination of the affected joint;Health Assessment Questionnaire, HAQ;CRP;RF;ESR;Anti-ccp TEST;Ultrasound examination of the affected joints was performed;Incidence of adverse reactions; | — |
Countries
China
Contacts
Guangdong Provincial Hospital of Chinese Medicine