Lyophilised fecal microbiota capsules for active rheumatoid arthritis that hasn’t responded to standard medicines

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a 24-week, randomized, double-blind, placebo-controlled trial at a single center. Forty adults with active, refractory rheumatoid arthritis will receive either lyophilised oral fecal microbiota capsules or placebo, in addition to their stable background medication. The study aims to assess whether the capsule therapy can improve disease activity and is designed to evaluate safety as well. Participants must meet standard RA criteria, have active disease, and maintain their current csDMARD regimen during the study. The trial is sponsored by Peking Union Medical College Hospital with collaboration from Qingdao Haier Biotech Co., LTD.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Lidan Zhao — Peking Union Medical College Hospital
• Study coordinator: Lidan Zhao
• Email: zhaolidan@hotmail.com
• Phone: 13810700035

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.