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Faecal Microbiota Transplantation in Patients With Refractory Rheumatoid Arthritis

ConditionRheumatoid Arthritis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPeking Union Medical College Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • lyophilised oral capsules with faecal microbiota

    Drug

    Faecal microbiota is extracted from fresh stool collected from strictly screened health donors with canonical procedure, and then lyophilised and prepared into oral capsule.

  • Placebo capsules

    Drug

    placebo capsules with the same appearance as FMT capsules but no microbiota inside

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: FMT groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

ACR 20/50 response rates at 16 weeks

at week 16, the difference in ratio of participants who achieve ACR 20/50 response in two groups.

Time frame
week 16

Secondary outcomes

1

ACR70 response at 16 weeks

at week 16 and week 24, the difference in ratio of participants who achieve ACR 70 response in two groups.

Time frame
week 16
2

ACR20/50/70 response at 24 weeks

at week 24, the difference in ratio of participants who achieve ACR 20/50/70 response in two groups.

Time frame
week 24
3

DAS 28 (CRP) and DAS 28 (ESR) at 16 and 24 weeks

at week 16 and week 24, the difference of diease activity evaluated by DAS 28 (CRP) and DAS 28 (ESR) in two groups

Time frame
week 16 and week 24
4

EULAR response rates at 16 and 24 weeks;

at week 16 and week 24, the difference of EULAR response evaluated based on DAS 28 (CRP) or DAS 28 (ESR) in two groups

Time frame
week 16 and week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking Union Medical College Hospital

Lead sponsor

Qingdao Haier Biotech Co., LTD

Collaborator

Source ClinicalTrials.gov
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