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Efficacy and safety of tocilizumab mono-therapy in patients with large vessel vasculitis (LVV; giant cell arteritis or Takayasu arteritis) and polymyalgia rheumatica (PMR)

Efficacy and safety of tocilizumab mono-therapy in patients with large vessel vasculitis (LVV; giant cell arteritis or Takayasu arteritis) and polymyalgia rheumatica (PMR) - Treatment of LVV and PMR by tocilizumab mono-therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000008812
Enrollment
40
Registered
2012-10-01
Start date
2012-10-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Rheumatoid arthritis

Interventions

Sponsors

Department of Rheumatology & Clinical Immunology Saitama Medical Center, Saitama Medical Universitity
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who fulfilled the 1990 ACR classification criteria for giant cell arteritis and Takayasu arteritis and the 2012 EULAR/ACR provisional classification criteria for PMR 1) Bloch DA, et al.: The ACR 1990 criteria for the classification of vasculitis. Patients and methods. Arthritis Rheum 1990; 33:1068-1073 2) Dasgupta B, et al.: 2012 Provisional classification criteria for polymyalgia rheumatica: a EULAR/ACR collaborative initiative. Arthritis Rheum 2012; 64: 943-954

Exclusion criteria

Exclusion criteria: 1) patients who are prohibited to use tocilizumab by the JCR guideline for proper tocilizumab use 2) patients who are thought to be inappropriate for the treatment with tocilizumab by their attending doctor

Design outcomes

Primary

MeasureTime frame
mprovement of major clinical signs and symptoms at week 12(fever,abnormal findings of temporal artery, myalgia, serum CRP, ESR, abnormal radiological findings of the affected vessels)

Secondary

MeasureTime frame
Improvement of major clinical signs at week 52, relapse rate and adverse events during 52 weeks

Countries

Japan

Contacts

Public ContactRyota Sakai

Saitama Medical Center, Saitama Medical Universitity Department of Rheumatology & Clinical Immunology

r_sakai@saitama-med.ac.jp0492283574

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026