Skip to content

A National Multicenter, Observational Single-Arm Real-World Study of Biological or Targeted Synthetic DMARDs Combined with Subcutaneous Methotrexate in the Treatment of Rheumatoid Arthritis

A National Multicenter, Observational Single-Arm Real-World Study of Biological or Targeted Synthetic DMARDs Combined with Subcutaneous Methotrexate in the Treatment of Rheumatoid Arthritis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500103304
Enrollment
Unknown
Registered
2025-05-27
Start date
2025-06-30
Completion date
Unknown
Last updated
2025-06-02

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

Conditions

Rheumatoid arthritis

Interventions

Sponsors

South China Hospital Affiliated to Shenzhen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Aged 18 years and above, regardless of gender; (2) Clinically diagnosed with rheumatoid arthritis; (3) Agree to participate in this study, be able to cooperate with the follow-up, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients during pregnancy or lactation, or those with a pregnancy plan within 6 months from the period of methotrexate use till its discontinuation; (2) Those with a history of chronic or recurrent infection (such as tuberculosis, chronic viral hepatitis, etc.) or with severe infection; (3) Those complicated with severe, progressive or uncontrolled diseases of the kidneys, liver, blood, gastrointestinal tract, immune system, endocrine system, cardiopulmonary system, mental or nervous system; (4) Those with recurrent or persistent oral ulcers; (5) Those with a history of malignant tumor within the past 5 years; (6) Those with the following abnormal laboratory results: hemoglobin 2× the upper limit of the normal (ULN), alanine aminotransferase (ALT) > 2×ULN, total bilirubin > 5mg/dL (85.5µmol/L), serum creatinine > 1.5 × ULN; (7) Those who participated in other clinical studies within 3 months before enrollment; (8) Those allergic to the relevant drugs used in this study; (9) Those with a history of drug abuse, mental illness or alcoholism and unable to cooperate with the clinical study; (10) Patients who need to use two or more b/tsDMARDs simultaneously during the study period; (11) Other situations deemed by the researcher as inappropriate for participation in this clinical study.

Design outcomes

Primary

MeasureTime frame
DAS28-ESR;

Secondary

MeasureTime frame
patient's global assessment of disease activity, PGA;Clinical disease activity index, CDAI;EGA;VAS;

Countries

China

Contacts

Public ContactCibo Huang

South China Hospital Affiliated to Shenzhen University

Huangcibo1208@139.com+86 158 1099 9904

Outcome results

None listed

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