RC18 in Patients With Relapsing Remitting Multiple Sclerosis：a Phase II Trial

Exclusion Criteria18

• Patients who were unable to undergo magnetic resonance imaging or who were allergic to gadolinium contrast agents during the trial
• In addition to multiple sclerosis, patients with chronic active immune system diseases or who are stable but require immunotherapy (glucocorticoids and/or immunosuppressants) (e.g., rheumatoid arthritis, scleroderma, Sjogren's syndrome, Crohn's disease, ulcerative colitis), Or patients with known immunodeficiency syndromes (AIDS, genetic immunodeficiency, and drug-induced immunodeficiency); Patients who received glucocorticoid maintenance therapy before randomization could participate in the trial after discontinuing the drug.
• Patients who were AQP4 antibody positive and/or MOG antibody positive within 1 year prior to randomization
• Patients who have received the following treatment:
• Interferon, pegylated interferon, glatirex acetate, and dimethyl fumarate were used within 4 weeks prior to randomization.
• Use of Fingomod, intravenous immunoglobulin, or plasmapheresis within 12 weeks prior to randomization.
• Alemtuzumab, Daclizumab, Ocrelizumab were administered within 24 weeks prior to randomization.
• Azathioprine (AZA, half-life t1/2=6hrs), Mycophenolate Mofetil (t1/2=16hrs), Leflunomide (LEF, LEflunomide) were used before randomization. t1/2=15 days), Tacrolimus (t1/2=43 hrs), Teriflunomide (t1/2=18 days), Cyclosporin (CsA) Patients with immunosuppressants such as t1/2=27 hrs), Methotrexate (MTX, t1/2=14hrs), Cyclophosphamide (CTX, t1/2=6hrs), in addition to leflunomide and teriflunomide, The discontinuation interval was more than 5 times the half-life. Leflunomide and Teriflunomide need to be eluted with coletenide, which can be discontinued and the following measures taken: Coletenide 8 g 3 times daily for 11 days, if the 8 g dose is not tolerated, can be changed to 4 g orally for the same time and frequency as before.
• Use of clatribine or mitoxantrone within 1 year prior to randomization.
• Received lymphoid irradiation and bone marrow transplantation before randomization.
• Patients were participated in any clinical trial 28 days before randomization or within 5 times half-life of study drug participating in clinical trial (whichever is longer).
• Patients with any persistent or chronic active infection or serious infection history in the screening period, such as shingles; active tuberculosis (patients with latent tuberculosis can participate in the test if they are given isoniazid and / or rifampin at the same time); HIV infection; syphilis antibody positive; HCV antibody positive; HBsAg positive; HBsAg negative but HBcAb positive, the HBV-DNA quantitative test is needed. If the HBV-DNA is positive, the patient should be excluded. If the HBV-DNA is negative, the patient can not be excluded.
• The results of abnormal laboratory tests to be excluded include but are not limited to: Leukocyte count \< 3 × 10\~9 / L; neutrophil \< 1.5 × 10\~9 / L; hemoglobin \< 85g / L; platelet count \< 80 × 10\~9 / L; serum creatinine \> 1.5 × ULN, accompanied by creatinine clearance \< 50ml / min (measured value, or calculated by Cockcroft Gault formula); total bilirubin \> 1.5 × ULN; ALT \> 3 × ULN; AST \> 3 × ULN; alkaline phosphatase \> 2 × ULN; IgG \< lower limit of normal value; IgM \< lower limit of normal value;
• Cancer patients
• Pregnant women, lactating women and patients with family planning during the trial
• Patients with other mental disorders
• Patients who experienced any of the following events within 12 weeks before randomization: myocardial infarction, unstable ischemic heart disease, stroke, or NYHA class IV heart failure
• The researchers believe that the patients are compliant insufficiently or not suitable to participate in this study.