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Correlation analysis of changes in gut microbiota characteristics and efficacy of tofatib combined with methotrexate in the treatment of rheumatoid arthritis

Correlation analysis of changes in gut microbiota characteristics and efficacy of tofatib combined with methotrexate in the treatment of rheumatoid arthritis

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300077468
Enrollment
Unknown
Registered
2023-11-09
Start date
2023-11-15
Completion date
Unknown
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rheumatoid arthritis

Interventions

control group:None

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-75 years (including borderline values); 2. Diagnosis of rheumatoid arthritis using the 2010 American College of Rheumatology (ACR) criteria; 3. Choice of treatment with methotrexate in combination with tofacitibine. 4.Voluntary signing of informed consent form.

Exclusion criteria

Exclusion criteria: 1.2.1 Suffering from rheumatic immune diseases other than rheumatoid arthritis, including systemic lupus erythematosus, mixed connective tissue disease, scleroderma, and polymyositis. Patients with secondary Sjogren's syndrome accompanied by rheumatoid arthritis are allowed to enter the study. 1.2.2 Previously or currently suffering from inflammatory joint diseases other than rheumatoid arthritis (such as gout, reactive arthritis, psoriatic arthritis, serum negative spinal arthropathy, Lyme disease). 1.2.3 Primary or secondary immunodeficiency diseases (previously or currently active). 1.2.4 Previously or currently suffering from tumors. 1.2.5 There are serious and poorly controlled concomitant diseases, such as (but not limited to) neurological, cardiovascular, liver, kidney, gastrointestinal, endocrine diseases, which, in the judgment of the researcher, may hinder the participants from participating in this study. 1.2.6 The following infections are known: recurrent active bacteria, viruses, fungi, mycobacteria or other infections (including but not limited to tuberculosis and atypical mycobacterial disease, granulomatosis found in chest X-ray examination, hepatitis B and hepatitis C virus infection, HIV infection and herpes zoster, but not including nail bed fungus infection), or chronic infection history 6 months before screening, Or there may be any major outbreak of infection that requires hospitalization or intravenous antibiotic treatment within 4 weeks prior to screening, or oral antibiotic treatment within 2 weeks prior to screening, or a positive tuberculosis screening during screening. 1.2.7 Subjects who received live/attenuated vaccines within 4 weeks prior to the screening visit or who are known to receive live/attenuated vaccines during the 24 week treatment observation period. 1.2.8 Female subjects who have tested positive during pregnancy, lactation, or screening. 1.2.9 The researcher determined that the subjects did not meet the inclusion criteria.

Design outcomes

Primary

MeasureTime frame
Abundance of gut microbiota;

Secondary

MeasureTime frame
cytokine;ACR20;erythrocyte sedimentation rate;c reactive protein;anti-cyclic citrullinated peptide antibodies;Lymphocyte subpopulation;DAS28;

Countries

China

Contacts

Public ContactHuang Jia

Beijing Hospital

13811655156@163.com+86 138 1165 5156

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026