In this 24-week, single center, randomized, double-blind, placebo-controlled study, the efficacy and safety of lyophilised oral fecal microbiota transplantation in patients with active refractory rheumatoid arthritis will be evaluated.
Age 18-65 years with informed consent;
Fulfill the 2010 ACR/EULAR classification criteria for rheumatoid arthritis;
Positive RF or anti-CCP antibody on screening;
Active disease status with swollen joint count(SJC)≥3 and tender joint count(TJC)≥3 and ESR >25 mm/hr or hypersensitive C-reactive protein > 10 mg/L;
Pregnant, lactating or further fertility requirements
History of any inflammatory rheumatological disorders other than RA;
Having used biologics or small-molecular targeting agents in 6 months prior to screening;
Taking oral glucocorticoid (GC) or get GC injection (intra-articular or parenteral) in one month prior to screening;
Peking Union Medical College Hospital
Lead sponsor
Qingdao Haier Biotech Co., LTD
Collaborator