Rheumatoid Arthritis
Conditions
Interventions
Control:Normal Saline iv. besides MTX treatment
Treatment:GMSC iv. besides MTX treatment
Sponsors
theThird Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) The American Classification of Rheumatology (ACR) revised RA classification criteria in 1987 or the 2010 ACR/EUALAR RA classification criteria, and the erythrocyte sedimentation rate or C-reactive protein is greater than the normal range; (2) Aged 18 to 65 years old; (3) The results of the pregnancy test for female subjects (career age) during the screening period should be negative and agree to use effective contraception during the study period. Menopausal, hysterectomy, bilateral tubal ligation, and/or bilateral salpingectomy, or female subjects with congenital infertility are considered to have no fertility; (4) Voluntary signing of informed consent; (5) Subjects have been taking MTX for at least 8 weeks prior to baseline visits. The dose was stable within 4 weeks prior to randomization; (6) If the subject is taking other DMARDs (except MTX) at screening, discontinue the test for at least 4 weeks prior to randomization. However, leflunomide was discontinued for at least 12 weeks before randomization of the trial. If less than 12 weeks, it took 11 days of cholestyramine, cholestyramine, 3 times a day, 8 grams each time; (7) If the subject is receiving corticosteroids during screening, the dose (equivalent to the dose of prednisone) must be stable at =10 mg/day for at least 4 weeks (before randomization); (8) If the subject is taking NSAIDs of non-steroidal anti-inflammatory analgesic drugs during screening, the dose is stable for at least 4 weeks (before randomization); (9) Patients with moderate to severe active RA at screening were defined as DAS28 >3.2.
Exclusion criteria
Exclusion criteria: 1. Exclusion criteria related to rheumatoid arthritis diseases: (1) subjects with any other inflammatory arthritis (such as juvenile chronic arthritis, Crohn's disease (Crohn's disease), ulcerative colitis, active vasculitis, gout, psoriatic arthritis or tonic Sexual spondylitis). (2) Subjects have secondary, non-inflammatory arthritis (such as osteoarthritis or fibromyalgia), and the investigators believe that the symptoms of this arthritis interfere with the evaluation of the efficacy of the study drug. However, secondary Sjogren's syndrome (Sj?gren), thyroiditis need not be excluded. (3) The subject has a history of artificial joint infection, regardless of when the infection occurred and the artificial joint is still in the body. (4) Subjects underwent >3 arthroplasty for RA and/or shoulder-hand syndrome grade VI. (5) line stage of the V subjects reached stage IV. (6) The subject's joint function was graded to VI or V. 2. Subjects are not allowed to accept the banned drugs detailed in the table below: Concomitant medications that were disabled at baseline visit; Drug type exclusion criteria; Analgesics (including paracetamol and acetaminophen) are used within 24 hours prior to baseline joint assessment Non-steroidal anti-inflammatory analgesic drugs NSAIDs/COX-2 inhibitors Dosing regimen within 14 days prior to baseline joint assessment; Any change; Oral glucocorticoids Any dose change within 28 days prior to baseline joint assessment. The maximum allowable dose per day does not exceed (equivalent to the dose of prednisone) 10mg/day; Intramuscular/intravenous/intraarticular injection of glucocorticoids used within 28 days prior to baseline joint assessment; Intra-articular injection of hyaluronic acid for use within 28 days prior to baseline joint assessment; Tripterygium wilfordii or other traditional Chinese medicine for treating RA is used within 28 days before baseline joint assessment; 3. The investigator confirmed that the subject had current or recent severe, progressive and uncontrolled heart, lung, liver, kidney and other important organs and blood, endocrine system lesions and medical history. Abnormal laboratory indicators that need to be excluded from the subject include, but are not limited to: (1) Laboratory parameter exclusion criteria: Parameter abnormal standard; White blood cell count 135µmol/L or 5 times the upper limit of the laboratory reference range (whichever is lower); Total bilirubin >1.5 times the upper limit of the laboratory reference range; AST (GOT) > 2 times the upper limit of the laboratory reference range; ALT (GPT) > 2 times the upper limit of the laboratory reference range; Alkaline phosphatase > 2 times the upper limit of the laboratory reference range; AST = aspartate aminotransferase; GOT = aspartate aminotransferase; ALT = alanine aminotransferase; GPT = alanine aminotransferase; 4. HBsAg-surface antigen positive patients are not allowed to be selected, but only those who are positive for HBc single positive are added for HBV-DNA quantitative detection. If HBV-DNA is negative, it is not considered as exclusion; 5. Patients with positive hepatitis C antibody (anti-HCV); 6. Those infected with herpes zoster or HIV infection during the screening period; 7. Subjects at high risk of infection. For example: leg ulcers, indwelling catheters, persistent or recurrent ches
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Response Rate of ACR50 and ACR 70 in 24 weeks posttreatment interview;Changes in the duration of morning stiffness relative to baseline values and percentage changes at all time points;Changes in the ACR core indicators relative to baseline values and percentage changes at all time points;ACR20, ACR50 and ACR70 response rates for weeks 4-24;Actual scores and changes from baseline values for DAS28 (ESR) for weeks 4-24;At 4-24 weeks, the measured values of laboratory tests (including blood routine, liver function, and C-reverse protein) and changes from baseline values;Number and function of T cell subsets; | — |
Primary
| Measure | Time frame |
|---|---|
| ACR20 percentage of patients in 24 weeks posttreatment interview; | — |
Countries
China
Contacts
Public ContactSongguo Zheng
the Third Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed