rheumatoid arthritis
Conditions
Interventions
Treatment group:TUL01101 tablets (70mg) were taken orally once a day and methylphenanthrene tablets (10mg) were taken orally once a week. This study consists of two stages: screening period and treatm
Sponsors
Clinical Trial Center of Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be enrolled 1, age range from 18 to 65 years old (including both ends of the value), male and female. 2. The index (BMI= weight/height square (kg/m2)) is in the range of 19 to 26 (including the values at both ends). 3. A diagnosis of rheumatoid arthritis meets the American College of Rheumatology (ACR) classification criteria of 1987 (see Appendix 1) or the American College of Rheumatology (ACR European League Against Rheumatism (EULAR) classification criteria of 2010 (see Appendix 2). 4. Patients who took a steady dose of 10mg/ week methylacetophenin tablets during the first 4 weeks of enrollment, and could maintain the same dose during the study period according to the researchers' assessment, and were willing to stop all other drugs except the study drugs during the study period. 5. Volunteer to participate in this experiment and sign informed consent in person.
Exclusion criteria
Exclusion criteria: Subjects who meet one or more of the following criteria will be excluded: 1. Known history of allergic reaction to any of the ingredients and/or other similar products under study; (2) Prior use of any of the following drugs or treatments: 1) Prior use of JAK inhibitors (including not limited to tofacatib, Baritinib, Pefieitinib, upatinib, and felotinib) within 12 weeks prior to initial administration; 2) Have used traditional synthetic antirheumatic drugs (csDMARDs), including but not limited to leflunomide, sulfoazopyridine, chloroquine/hydroxychloroquine, gold preparations, penicillamine, Eramod, Discontinuation time before initial administration of the test drug 11 days), And the patients who stopped cholestyramine for more than 6 hours could be enrolled in the group], sulazazopyridine for 5 days, chloroquine/hydroxychloroquine, gold preparation for 30 weeks, penicillamine for 30 days, eramode for 3 days) or other drugs known to have strong immunosuppressive or immunomodulatory effects, such as tacrolimus, Pavlin, etc., used within 3 months before screening; 3) Biologically-modified antirheumatic drugs (bDMARDs) should be used within 12 weeks before the first dose or during the trial. Including but not limited to anti-tumor necrosis factor (TNF) -a antagonists, interleukin, (IL) -1 antagonists, IL-6 antagonists, anti-CD20 monoclonal antibody and T-cell co-stimulatory molecular inhibitors, etc.); 4) Use of any non-steroidal anti-inflammatory drugs (NSAIDs) or oral glucocorticoids, and stop time before the first dose <7 drug half-lives; 5) Intramuscular, intravenous or joint injection of corticosteroid drugs, or oral administration of tripterygium wilfordii, total glucoside of paeony, sinomine and other Chinese patent medicines or Chinese herbs within 4 weeks before the first administration; 6) Received interferon therapy within 4 weeks prior to the first administration, such as roxanone, galanone, Roxanone, Alferon-N, Peroxone, Avonas, betaerone, chifuzine, actimmune, Pyroxin, Andafen, Dianol, Flucontel, etc.; 7) Have received or been exposed to live epidemic surfaces or attenuated live vaccines within 4 weeks prior to initial administration or plan to receive live vaccines or attenuated live vaccines during the trial period; 8) Drugs (including prescription and over-the-counter drugs), vitamins and food supplements used within 4 weeks prior to initial administration of CYRSA as a depressant or a strong inducer (see Appendix 3); 9) Other drugs (including prescription drugs and over-the-counter drugs) are being used, and the time of drug withdrawal before the first administration is less than 7 drug half-lives; 10) Used lymphocyte depletion agents/therapy, alkylating agents, total lymphoid irradiation and other treatments within 3 months prior to screening or plan to use them during the study period; 11) Patients who had a major trauma or underwent severe surgery within 4 weeks prior to screening or who planned to undergo major surgery during the trial period; 3. Have a history or evidence of any of the following diseases 1) Have other systemic inflammatory diseases other than RA (other than secondary Sjogren's syndrome), including but not limited to juvenile chronic arthritis, Crohn's disease, ulcerative colitis, psoriatic arthritis, systemic lupus erythematosus, ankylosing spondylitis, systemic vasculitis, or active gout; 2) Those with heredi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood concentration;Incidence of adverse reactions;Physical examination;Vital sign;electrocardiogram;Laboratory test indicators; | — |
Countries
China
Contacts
Public ContactGuoping Yang/Hao Zhang
Clinical Trial Center of the Third Xiangya Hospital of Central South University
Outcome results
None listed