Rheumatoid arthritis
Conditions
Interventions
experimental group:KL130008
placebo group:Placebo group
Sponsors
West China Hospital Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Be able to understand the procedures and methods of the study, be willing to complete the trial strictly following the clinical trial protocol, and sign the informed consent voluntarily; 2) Ages 18 to 65 years (inclusive), male or female; 3) Body mass index [BMI = weight / height square (kg / m2)] >= 18 and = 6 tender joints (TJC) (based on 68 joint counts) and >= 6 swollen joints (SJC) (based on 66 joint counts) at screening and before randomization. And the erythrocyte sedimentation rate (ESR) > 28 mm / h or C-reactive protein (CRP) > 1.2 times the upper limit of the normal range (ULN) during screening. 6) Patients who have previously used at least one of conventional synthetic disease modifying antirheumatic drugs (csDMARDs), but with poor efficacy (medication time >= 3 months) or intolerance, and have completed drug eluting for 5 half-life before randomization; 7) Patients who have previously used at most one biological disease modifying antirheumatic drugs (bDMARD), the medication time is less than 3 months, and have completed drug eluting for 5 half-life before randomization (not less than 3 months); 8) During the study period and within 3 months after the end of study drug administration, subjects with fertility must receive effective medical contraception (regardless of male or female subjects).
Exclusion criteria
Exclusion criteria: 1) Patients with a known history of allergic reactions to any of the ingredients and / or other similar products treated in this study; 2) Previously used any of the following drugs or treatments: a. JAK inhibitors (including but not limited to tofacitinib, Baricitinib and Filgotinib) or participated in clinical trials and used the test drugs; b. Patients who have used bDMARD (including but not limited to tumor necrosis factor (TNF) -a antagonists, interleukin (IL) -1 antagonists, IL-6 antagonists, anti-CD20 monoclonal antibodies, and T cell costimulatory molecule inhibition Agents, etc.), or subjects who have participated in clinical trials and used the test drugs, and judged by the investigator to have insufficient response (lack of efficacy) to bDMARD; c. Patients who have received any parenteral (such as intramuscular, intravenous, etc.) or intra-articular corticosteroids within the first 4 weeks of randomization; or who are using oral corticosteroids at a daily dose of > 10 mg prednisone (or equivalent Dose) or those whose dose are not stable within 4 weeks before randomization; d. Patients who are using non-steroidal anti-inflammatory drugs (except acetaminophen) and whose dose is not stable within 4 weeks before randomization; e. Patients who are using drugs such as acetaminophen, opioids, etc., whose doses are not stable until 5 half-life time (not less than 7 days) before randomization; f. Have received interferon treatment (such as roferon, INTRON A, Rebetron, Alferon-N, PEG-INTRON, Avonex, Betanolone, Infergen, interferon ?-1b, pegasys, Anterferon, Recombinant Human Interferon a2a, etc.); g. Patients who were vaccinated or exposed to live or attenuated live vaccines within the first 3 months of randomization or who plan to receive live or attenuated live vaccines during the trial; h. Patients who participated in any drug or medical device clinical trials within the first 3 months of randomization and used investigational drugs (including the placebo group) or treatment; i. Patients who have used strong CYP3A4 inhibitors or strong inducers (including prescription drugs, over-the-counter drugs, vitamins and food supplements) within 4 weeks before randomization; j. Within 4 weeks before randomization, in addition to the above drugs, other drugs known to have strong immunosuppressive or immunomodulatory effects (such as Total Glucosides of White Paeony Capsules, Tripterygium wilfordii, Mycophenolate Mofetil, Cyclosporine, Tacrolimus, azathioprine, 6-mercaptopurine, etc.); k. Patients who are using drugs other than the above (including prescription drugs, over-the-counter drugs, vitamins and food supplements) and whose doses are not stable until the 5 drug half-life time (not less than 7 days) before randomization; 3) History or evidence with any of the following diseases: a. Those with systemic inflammatory diseases other than RA (except secondary Sj?gren's syndrome), including but not limited to juvenile chronic arthritis, spondyloarthropathies, Crohn's disease, ulcerative colitis, psoriatic arthritis, systemic lupus erythematosus, axial arthritis (including ankylosing spondylitis and radionegative axial spinal arthritis), reactive arthritis, active vasculitis or gout; b. Infection of viruses, bacteria, fungi, parasites, mycoplasma, or chlamydia that requires systemic treatment within 1 month before screening; a ple with active infection who need to be treated with anti-infective drugs for injection within 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics / Pharmacodynamics;hematology panel;Blood chemistry panel; | — |
Countries
China
Contacts
Public ContactPing Feng
West China Hospital, Sichuan University
Outcome results
None listed