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A Prospective, Observational Study to Evaluate the Efficacy and Safety of Tocilizumab (Schereri®) in the Treatment of Rheumatoid Arthritis in the Elderly

A Prospective, Observational Study to Evaluate the Efficacy and Safety of Tocilizumab (Schereri®) in the Treatment of Rheumatoid Arthritis in the Elderly

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087546
Enrollment
Unknown
Registered
2024-07-30
Start date
2024-08-10
Completion date
Unknown
Last updated
2024-08-05

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

Conditions

Rheumatoid Arthritis in the Elderly

Interventions

Intervention group:Tocilizumab 8 mg/kg, administered intravenously over 1 hour, every four weeks for a total of 6 doses

Sponsors

The Second Hospital of Lanzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. voluntary participation in the study and signing of informed consent; 2. be aged = 60 years, male or female; 3. physician-confirmed diagnosis of rheumatoid arthritis that meets the diagnostic criteria for RA classification established by ACR/EULAR 2010; 4. active RA disease (DAS28 = 2.6); 5. no previous treatment with tolizumab; 6. good compliance and cooperation with follow-up visits.

Exclusion criteria

Exclusion criteria: 1. use of intra-articular or extra-gastrointestinal glucocorticoids for arthritis within 4 weeks prior to screening; 2. immunization with live vaccines within 4 weeks prior to screening; 3. history of underlying tuberculosis infection or tumor; 4. acute or chronic active infection; 5. concomitant other diffuse connective tissue diseases such as systemic lupus erythematosus, severe osteoarthritis of the knee and dry syndrome; 6. severe hepatic and renal insufficiency; 7. severe cardiac, cerebral and vascular pathology; 8. Presence of other conditions that, in the judgment of the investigator, make enrollment inappropriate.

Design outcomes

Primary

MeasureTime frame
Percentage of clinical remission(CDAI=2.8);

Secondary

MeasureTime frame
DAS28-ESR;EULAR Boolean 2.0;CDAI =10;ACR20/50/70;HAQ-DI;VAS;PtGA;MDGA;

Countries

China

Contacts

Public ContactShen Haili

The Second Hospital of Lanzhou University

shenhl@lzu.edu.cn+86 139 1932 9146

Outcome results

None listed

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