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Effect of adalimumab versus anti-drug antibody concentrations on clinical remission in rheumatoid arthritis: a multicenter cross-sectional study

Effect of adalimumab versus anti-drug antibody concentrations on clinical remission in rheumatoid arthritis: a multicenter cross-sectional study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500114446
Enrollment
Unknown
Registered
2025-12-11
Start date
2025-04-15
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

Rheumatoid arthritis

Interventions

Sponsors

Nanfang Hospital, Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily sign the informed consent form; Male and female patients aged >= 18 years and < 75 years 3. After receiving ADA treatment (40mg, q2w, subcutaneous) for more than 6 months but less than 2 years, it can be combined with other conventional synthetic antirheumatic drugs for improving the condition (csDMARDs), with a stable dose for more than 4 weeks. 4. When screening, if the subjects are taking non-steroidal anti-inflammatory and analgesic drugs (NSAIDS), the dosage should remain stable for at least 4 weeks. 5. If the subjects are taking oral corticosteroids during screening, the dose (equivalent to the dose of prednisone) must be kept stable at less than 10mg per day for at least 4 weeks.

Exclusion criteria

Exclusion criteria: 1. Those with a history of severe diseases of vital organs such as the heart, liver, and kidneys, as well as blood and endocrine system disorders; 2.Have received treatment with other biological agents within 6 months; 3. Pregnant and lactating women; 4. Those who are currently in the period of acute or chronic infection, or have a history of active tuberculosis; 5. Patients with malignant tumors; 6. Patients with mental illness or intellectual disability who have difficulty completing the content of the assessment questionnaire. 7. The researcher judged that it was not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Rheumatoid arthritis related indicators;Anti-adalimumab antibody concentration;DAS28 score;Adalimumab concentration;Methotrexate and methotrexate polyglutamate concentrations;HAQ score;

Secondary

MeasureTime frame
Liver and kidney function;

Countries

China

Contacts

Public ContactLiqian Mo

Nanfang Hospital, Southern Medical University

moliqian@126.com+86 20 6278 7235

Outcome results

None listed

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