💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
1. Age 18-65 years with informed consent;
2. Fulfill the 2010 ACR/EULAR classification criteria for rheumatoid arthritis;
3. Positive RF or anti-CCP antibody on screening;
4. 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;
5. Having received csDMARDs including but not limited to methotrexate (at a stable dose of 7.5 - 20 mg/week) for 3 months or longer prior to screening and willing to continue current regimen for the duration of the study;
6. Other csDMARDs (e.g. Leflunomide, Iguratimod, Sulfasalazine, Hydroxychloroquine, Tripterygium Wilfordii, etc.) taking before screening with dosage stablized for 3 months or longer are permitted and should continue during the duration of the study;
7. Class I, II or III of the ACR 1991 Revised Criteria for Global Functional Status in RA;
8. If taking non-steroidal anti-inflammatory drugs (NSAIDs), must be at a stable dose for at least two weeks prior to screening;
9. Female subjects must have a negative pregnancy test unless they are surgically sterile or have been post-menopausal for at least one year (12 consecutive months without menses) ;
10. Participants with fertility must use a medically effective form of contraception and agree to continue its use during the study or at least 3 monts after the last dose of study intervention.
11. Willing to suspend the use of other adjuvant treatment for the duration of the study including acupuncture, massage, etc.
Exclusion Criteria:
1. Pregnant, lactating or further fertility requirements
2. History of any inflammatory rheumatological disorders other than RA;
3. Having used biologics or small-molecular targeting agents in 6 months prior to screening;
4. Taking oral glucocorticoid (GC) or get GC injection (intra-articular or parenteral) in one month prior to screening;
5. Severe, progressive, or uncontrolled visceral disease including cardiac, pulmonary, renal, hepatic, gastrointestinal, hematologic, metabolic, endocrine or neurologic disease;
6. Severe enteritis, intestinal obstruction or bleeding, or history of gastrointestinal surgery.
7. Active infection in recent 3 months or persistent chronic infection, including HIV, HCV, HBV, tuberculosis;
8. Malignancy or history of malignancy;
8\. Other conditions that investigators consider inappropriate for this study.
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