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

NCT03944096 | Unknown Phase 2 DMC

• 1 other identifier: FARM
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

In this 24-week, single center, randomized, double-blind study, the investigators will evaluate the efficacy and safety of fecal microbiota transplantation in patients with active rheumatoid arthritis refractory to methotrexate

Conditions

Rheumatoid Arthritis

Keywords

fecal microbiota transplantation; methotrexate; rheumatoid arthritis

Outcome Measures

Primary Outcomes (1)

• The American College of Rheumatology 20 (ACR20) response at 16 weeks

  The difference of ACR20 between Arm 1 (FMT+MTX) and Arm 2 (autologous FMT+MTX)

  week 16

Secondary Outcomes (7)

• The American College of Rheumatology 50/70 (ACR50/ACR70) response at 16 weeks

  week 16

• The American College of Rheumatology 20/50/70 (ACR20/ACR50/ACR70) response at 24 weeks

  week 24

• The Disease Activity Score-28 (DAS28) response at 16 weeks

  week 16

• The Disease Activity Score-28 (DAS28) response at 24 weeks

  week 24

• The European League Against Rheumatism (EULAR) response at 16 weeks

  week 16

Study Arms (2)

FMT+MTX

EXPERIMENTAL

FMT One FMT is performed at baseline by gastroscopic guidance. The same FMT is repeated 4 weeks later. The transplant consists of 50 g mixed feces obtained from 3-5 non-related healthy donors. The donor feces is suspended into NaCl (0.9%) and glycerol (10%), and will be stored at minus 80 degrees celsius until use. The total volume of the suspension is 150 mL and its temperature will be 37 degrees celsius when infused into ileus of the recipient. Drug: Methotrexate (MTX) Weekly methotrexate

Procedure: FMT+MTX

autologous FMT+MTX

PLACEBO COMPARATOR

autologous FMT (the feces used in FMT is from participant themselves) One identical FMT is performed at baseline using gastroscopic guidance and is repeated 4 weeks later. The corresponding participant's feces is suspended into NaCl (0.9%) and glycerol (10%), and will be stored at minus 80 degrees celsius until use. The total volume of the suspension is 150 mL and its temperature will be 37 degrees celsius when infused into ileus of the participant himself or herself. Drug: Methotrexate (MTX) Weekly methotrexate

Procedure: FMT+MTX

Interventions

FMT+MTX PROCEDURE

FMT is performed at the beginning of the study and is repeated after 4 weeks plus MTX in the same dose.

FMT+MTX; autologous FMT+MTX

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Xuan Zhang, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yue Li, MD

CONTACT

+8618601309256; yuelee76@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 9, 2019
• Study Start: April 30, 2019
• Primary Completion: March 31, 2020
• Study Completion: July 31, 2020
• Last Updated: May 23, 2019

Record last verified: 2019-05

Locations

CN (1)