Rheumatoid arthritis
Conditions
Interventions
test group:KL130008 capsule
placebo group:placebo
Sponsors
West China Hospital Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Participants must meet all of the following conditions to be selected: 1) Able to understand the procedures and methods of this study, willing to strictly abide by the clinical trial protocol to complete the trial, and voluntarily sign the informed consent form; 2) The age at the time of signing the informed consent form is 18 to 75 years old (including 18 years old and 75 years old), regardless of gender; 3) With rheumatoid arthritis conform to the 2010 American College of Rheumatology (ACR)/EULAR (EULAR) classification standard, and the ACR function classification I~III. 4) Diagnosed as moderate to severely active RA at screening, having >= 6 tender joints (TJC) (based on 68 joint count) and >= 6 swollen joints (SJC) (based on 66 joint count) ) (Tenderness), the erythrocyte sedimentation rate (ESR)> 28 mm/h or C-reactive protein (CRP)> 1.2 ULN. Joints undergone major surgery or injected with hyaluronic acid within 6 weeks before randomization are not included in the TJC and SJC counts; 5) Fertile subjects must take effective contraceptive measures (regardless of male or female subjects) during the study and within 3 months after the ending of the administration.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will be excluded: 1) Have a history of allergic reactions to any component of the study treatment and/or other similar drugs; 2) Have used any of the following drugs or treatments in the past: a. Have used JAK inhibitor drugs (including but not limited to tofacitib, baritinib, peficitinib, upadacitinib and filgotinib), or those who have participated in clinical trials of these drugs and used experimental drugs; b. Have used traditional synthetic disease-improving anti-rheumatic drugs (csDMARDs) within the first 5 half-lives; c. Have used biologics anti-rheumatic drugs (bDMARDs, including but not limited to anti-tumor necrosis factor (TNF)-a antagonists, white blood cells) within 5 half-lives or 3 months (whichever is longer) before randomization Interleukin (IL)-1 antagonist, IL-6 antagonist, anti-CD20 monoclonal antibody, T cell costimulatory molecule inhibitor, etc.; d. Have used drugs with strong immunosuppressive or immunomodulatory effects (such as Pavlin, Tripterygium wilfordii, mycophenolate mofetil, cyclosporine, tacrolimus, azathioprine, 6-Mercaptopurine, etc.); e. Using oral corticosteroids with a daily dose> 10 mg of prednisone (or equivalent dose) or dose has not stabilized within 4weeks before randomization, or cannot continue to use the original stable dose during the trial; If stopped taking glucocorticoids, at least 2 weeks before randomization; f. Receiving or preparing to receive intra-articular or injectable glucocorticoid therapy in the 6 weeks before randomization and during the treatment (24 weeks), or planning to undergo joint surgery during the treatment (24 weeks); g. Dose of non-steroidal anti-inflammatory drugs (except acetaminophen) is not stable within 4 weeks before randomization, or who cannot continue to use the original stable dose during the trial; h. Received interferon treatment within 4 weeks before randomization (such as Ruinterferon, Ganleneng, Rebetron, Alferon-N, PegIntron, Avonex, Betalone, Ganfujin, Interferon ?-1b, Paero Xin, Andafen, Dienan, Fukangtai, etc.); i. Have been vaccinated or exposed to live vaccines or live attenuated vaccines within 3 months before randomization or plan to receive live vaccines or live attenuated vaccines during the trial; j. Participated in any drug or medical device clinical trial and used experimental drugs (including placebo control group) or treatment within 3 months before randomization; k. Have used CYP3A strong inhibitors or strong inducers drugs (including prescription drugs, non-prescription drugs, vitamins and food supplements) within 4 weeks before randomization; l. The doses of other drugs (including prescription drugs and over-the-counter drugs) other than the above-mentioned drugs (except for the eluting drugs of cholesterol and leflunomide) are not stable during the 5 half-lives (not less than 7 days) before random assignment 3) Have history or evidence of any of the following diseases: a. People with other systemic inflammatory diseases other than RA (except secondary Sj?gren's syndrome), including but not limited to juvenile chronic arthritis, Crohn's disease, ulcerative colitis, and psoriatic arthritis , Systemic lupus erythematosus, ankylosing spondylitis, reactive joint disease, systemic vasculitis or gout; b. People with Felty syndrome (Felty syndrome); c. Infected with viruses, bacteria, fungi, parasites, mycobacteria, mycoplasma, or chlamydia that require systemic treatment w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biomarkers: TNF-a, IL-6, IL-15, MMP-3 in serum.;KL130008 concentration in plasma;hematology panel;Blood chemistry panel; | — |
Countries
China
Contacts
Public ContactLiuYi/FengPing
West China Hospital of Sichuan University
Outcome results
None listed