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Study on the correlation between adalimumab therapeutic drug monitoring and clinical efficacy in patients with with moderate to severe active rheumatoid arthritis

Study on the correlation between adalimumab therapeutic drug monitoring and clinical efficacy in patients with moderate to severe active rheumatoid arthritis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500097416
Enrollment
Unknown
Registered
2025-02-19
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-02-24

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

Conditions

Moderate to severe rheumatoid arthritis

Interventions

No- response group:None

Sponsors

Suqian First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Be able to actively cooperate with this study and sign the informed consent; 2. Aged 18-70 years old (including 18 and 70 years old); 3. RA patients (diagnostic criteria referred to 1987 ACR classification criteria) and DAS28>3.2 4. Long-term residence at the trial site (at least 6 months) 5. Had not received adalimumab for 10 weeks before dosing 6. Adequate organ function (1) Bone marrow function: 1) hemoglobin >=100 g/L 2) absolute neutrophil count >= 1.5×109/L 3) white blood cell >= 3.0×109/L 4) platelet count >= 100×109/L (2) Liver function (based on the normal value of clinical trial center) : 1) Serum bilirubin = 60 ml/min/1.73m2 or serum creatinine <= 1.5× upper limit of normal value (ULN)

Exclusion criteria

Exclusion criteria: 1.Be pregnant; 2.Allergic to any component of adalimumab injection; 3.Presence of active infection (such as active tuberculosis), including local infection; 4.Patients with malignant tumors; 5.Moderate to severe heart failure; 6.Received live vaccine within 4 weeks before the start of the study or plan to receive any vaccine during the study period;

Design outcomes

Primary

MeasureTime frame
DAS28-CRP;

Secondary

MeasureTime frame
Clinical disease activity index (CDAI);

Countries

China

Contacts

Public ContactJin Xin

Suqian First Hospital

jinxin871211@163.com+86 527 80766212

Outcome results

None listed

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