Efficacy and Safety of Fecal Microbiota Transplantation in Patients With Rheumatoid Arthritis Refractory to Methotrexate

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03944096
• Date of registration: 08/05/2019
• Prospective Registration: No
• Primary sponsor: Peking Union Medical College Hospital
• Public title: Efficacy and Safety of Fecal Microbiota Transplantation in Patients With Rheumatoid Arthritis Refractory to Methotrexate FARM
• Scientific title: Efficacy and Safety of Faecal Microbiota Transplantation in Patients With Rheumatoid Arthritis Refractory to Methotrexate: a 24-week, Double-Blind, Randomised Trial
• Date of first enrolment: April 30, 2019
• Target sample size: 30
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03944096
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

China

Contacts

• Name: Xuan Zhang, MD
• Affiliation: Peking Union Medical College Hospital

• Name: Yue Li, MD

• Name: Yue Li, MD

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

- Have active RA shown by swollen joint count(SJC)=4 and tender joint count(TJC)=4 and
ESR >28 mm/hr or C-reactive protein > 1.5 ULN

- Have received methotrexate for 3 months or longer and at a stable dose of 7.5 to 25
mg/week (extremes included) for at least four weeks prior to screening and willing to
continue on this regimen for the duration of the study.

- Class I, II or III of the ACR 1991 Revised Criteria for Global Functional Status in RA

- If taking oral steroids, these should be at a dose =10 mg/day of prednisone or
prednisone equivalent and stable for at least four weeks prior to screening;

- If taking non-steroidal anti-inflammatory drugs (NSAIDs), these 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);

- Women of childbearing potential must use a medically acceptable means of birth control
and agree to continue its use during the study and for at least four weeks after the
last dose of study drug. Sexually active men must agree to use a medically acceptable
form of contraception during the study and continue its use for at least 3 months
after the last dose of study drug; and

- Willing to suspend the use of other adjuvant treatment for the duration of the study
including acupuncture, massage, etc.

Exclusion Criteria:

- Pregnant, lactating or further fertility requirements

- History of any inflammatory rheumatological disorders other than RA;

- Previously received any biologic agents.

- Treatment with disease-modifying antirheumatic drugs (DMARDs), other than background
methotrexate;

- Receipt of an intra-articular or parenteral corticosteroid injection within four weeks
prior to screening;

- Active or chronic infection, including HIV, HCV, HBV, tuberculosis.

- Malignancy or history of malignancy.

- Severe, progressive, or uncontrolled cardiac, pulmonary, renal, hepatic,
gastrointestinal, hematologic, metabolic, endocrine or neurologic disease

- unable to undergo colonoscopy.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Procedure: FMT+MTX

Primary Outcome(s)

The American College of Rheumatology 20 (ACR20) response at 16 weeks [Time Frame: week 16]

Secondary Outcome(s)

Health Assessment Questionnaire without Didability Index (HAQ-DI) at 16 weeks [Time Frame: week 16]

The European League Against Rheumatism (EULAR) response at 16 weeks [Time Frame: week 16]

The American College of Rheumatology 50/70 (ACR50/ACR70) response at 16 weeks [Time Frame: week 16]

Incidence of adverse events and sever adverse events (SAE) during the study [Time Frame: week 24]

The Disease Activity Score-28 (DAS28) response at 16 weeks [Time Frame: week 16]

The Disease Activity Score-28 (DAS28) response at 24 weeks [Time Frame: week 24]

The American College of Rheumatology 20/50/70 (ACR20/ACR50/ACR70) response at 24 weeks [Time Frame: week 24]

Secondary ID(s)

FARM

Source(s) of Monetary Support

Please refer to primary and secondary sponsors