Efficacy and Safety of Lyophilised Oral Faecal Microbiota Transplantation in Patients With Active Refractory Rheumatoid Arthritis- A Randomized Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
Rheumatoid arthritis (RA) is a chronic autoimmune disease, characterized by synovium inflammation and bone and joint erosions, leading to pain, morbidity and increased motality. Nearly half of RA patients displayed incomplete response or intolerance to the anchor drug-methotrexate. Gut microbiota plays an important role in the pathophysiology of RA and abnormal gut microeology has been documented in RA. FMT(fecal microbiota transplantation) is the engraftment of gut microbiota from healthy donors into a recipient, to ideally restore the normal gut microbial community structure. Hopefully, FMT could act as a promising strategy to improve disease control in refractory RA. Oral lyophilised fecal microbiota capsule provides a readily accessible and non-invasive way for FMT. This study will evaluate the efficacy and safety of lyophilised oral FMT in patients with active RA refractory to conventional synthetic disease modifying antirheumatic drugs (csDMARDs）with or without biological DMARDs (bDMARDs）or targeting-synthetic DMARDs (tsDMARDs）.
Objectives:
To evaluate the efficacy of lyophilised oral FMT capsule in the treatment of active RA patients refractory to csDMARDs with or without bDMARDs or tsDMARDs； To evaluate the safety of lyophilised oral FMT capsule in the treatment of active RA patients refractory to csDMARDs with or without bDMARDs or tsDMARDs；
DESIGN
This is a Phase 2, randomized, 24-week, double-blind, placebo-controlled study, and 40 patients with active RA refractory to csDMARDs will be randomized in a 1:3 ratio to one of the following 2 parallel treatment arms:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •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;
- •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;
- •Class I, II or III of the ACR 1991 Revised Criteria for Global Functional Status in RA;
- •If taking non-steroidal anti-inflammatory drugs (NSAIDs), must be at a stable dose for at least two weeks prior to screening;
- •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) ;
- •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.
- •Willing to suspend the use of other adjuvant treatment for the duration of the study including acupuncture, massage, etc.
排除标准
- •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;
- •Severe, progressive, or uncontrolled visceral disease including cardiac, pulmonary, renal, hepatic, gastrointestinal, hematologic, metabolic, endocrine or neurologic disease;
- •Severe enteritis, intestinal obstruction or bleeding, or history of gastrointestinal surgery.
- •Active infection in recent 3 months or persistent chronic infection, including HIV, HCV, HBV, tuberculosis;
- •Malignancy or history of malignancy;
- •8. Other conditions that investigators consider inappropriate for this study.
研究者
Lidan Zhao
Prof.
Peking Union Medical College Hospital