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Evaluation the efficacy and safety of adalimumab injection (SCT630) with rheumatoid arthritis (RA): A multicenter, prospective, real-world study

Evaluation the efficacy and safety of adalimumab injection (SCT630) with rheumatoid arthritis (RA): A multicenter, prospective, real-world study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300074783
Enrollment
Unknown
Registered
2023-08-16
Start date
2023-08-20
Completion date
Unknown
Last updated
2023-11-06

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

Conditions

Rheumatoid arthritis

Interventions

Treatment group receiving Adalimumab (SCT630):NA

Sponsors

The First Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Age = 18 years old, regardless of gender; (2) Clinically diagnosed as rheumatoid arthritis (RA); (3) Doctor's prescription: Adalimumab injection (SCT630); (4) Ability to complete research related evaluations and records; (5) Volunteer to participate in the study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: Patients who meet any of the following criteria will be excluded from this trial : ( 1 ) known to be allergic to adalimumab or preparation excipients ; ( 2 ) Patients who had previously been treated with adalimumab and were ineffective ; ( 3 ) active tuberculosis or other serious infectious diseases ; ( 4 ) patients with moderate to severe heart failure ( NYHA grade III / IV ) ; ( 5 ) patients with malignant tumor ; ( 6 ) pregnant or lactating women ; ( 7 ) Other situations judged by the researchers not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Health Assessment Questionnaire,HAQ;

Secondary

MeasureTime frame
American Society of Rheumatology (ACR) 20 Response RateAmerican Society of Rheumatology (ACR) 20 Response Rate;ACR50 response rate;Number of tenderness joints;Number of swollen joints;C-reactive protein;Erythrocyte sedimentation;Rheumatoid arthritis disease activity score (DAS28);

Countries

China

Contacts

Public ContactLan He

The First Affiliated Hospital of Xi'an Jiaotong University

xajdljn@126.com+86 138 0915 6236

Outcome results

None listed

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