Rheumatoid Arthritis
Conditions
Interventions
Treatment group:IGU 25mg bid + adalimumab 40mg q2w
Sponsors
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 65 years, male or female; 2.Bodyweight >= 40kg; 3.Patients who meet the diagnostic criteria of RA introduced by ACR in 1987 or ACR\EULAR in 2010 are diagnosed with rheumatoid arthritis (RA); 4.Active RA (the following three criteria are met, defined as active RA: (1) >= 6 joint swelling [66 joint counts]; (2) >= 6 joint tenderness [68 joint counts]; (3) ESR > 28 mm/h or C-reactive protein (CRP) > 1.0 mg/dL); 5.Patients who have been treated with csDMARDs for >= 3 months and have been treated with a stable dose of csDMARDs for 4 consecutive weeks before entering the study(According to the 2018 "Guidelines for the diagnosis and treatment of rheumatoid arthritis in China", poor response, i.e., no significant improvement in RA disease activity within 3 months or failure to achieve treatment goals within 6 months); 6.Subjects must be able and willing to conduct self-administer subcutaneous (SC) injections, or a qualified person must be available for administer SC injections; 7.If taking glucocorticoids, prednisone should be less than or equal to 10 mg or a dose equivalent to prednisone, and the dose should remain unchanged for at least 28 days; 8.No use of any biologics (bDMARDs) within 6 months before enrollment; 9.Understand the purpose and test procedures of this trial, and sign the written informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1.In the previous treatment of rheumatoid arthritis, solid immunosuppressive drugs (such as cyclophosphamide, cyclosporine, azathioprine, etc.), tripterygium wilfordii, and other drugs that affect the efficacy evaluation have been used, and the drug has been stopped for less than 4 weeks; 2.History of allergy to the experimental drug; 3.Subjects were recently vaccinated with live vaccines or planned to use any live vaccines during the study; 4.History of infection requiring hospitalization, parenteral antimicrobial therapy, clinically significant infection in the investigator's opinion within 6 months before the first dose of study drug, or any history of infection requiring antimicrobial therapy within 2 weeks before the first dose of study drug; 5.Current or recent history of clinically uncontrolled kidney, liver, blood, gastrointestinal, endocrine, metabolic, pulmonary, cardiac, or neurological disease; 6.History of other autoimmune rheumatic diseases other than Sjogren's syndrome; 7.The chest X-ray results showed pulmonary tuberculosis, pulmonary interstitial fibrosis, and other diseases; 8.Psychopath; 9.ALT and AST exceeded 1.5 times the upper limit of normal, and creatinine exceeded 1.5mg/dl or 135umol/L; 10.WBC < 3 x 10^9/L, HGB < 85g/L, PLT < 100 x 10^9/L; 11.Pregnant women, breastfeeding women, and men or women conceiving recently; 12.A history of heavy drinking; 13.Patients who participated in clinical trials of other new drugs within 3 months; 14.Other conditions in the investigator's opinion are that the patient is not suitable for entry into the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ACR20; | — |
Secondary
| Measure | Time frame |
|---|---|
| ACR20;ACR50;ACR70;HAQ score;DAS28-ESR; | — |
Countries
China
Contacts
Public ContactSun Hongsheng
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Outcome results
None listed