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Faecal Microbiota Transplantation in Patients With Refractory Rheumatoid Arthritis
Faecal Microbiota Transplantation in Patients With Refractory Rheumatoid Arthritis

NCT07639177

Not Yet RecruitingPhase 2

Sponsor: Peking Union Medical College Hospital

Conditions: Rheumatoid Arthritis

Interventions: lyophilised oral capsules with faecal microbiota, Placebo capsules

Countries: China

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (1)
  • Beijing, Beijing Municipality, China