UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008812 |
|---|---|
| Receipt number | R000010359 |
| Scientific Title | Efficacy and safety of tocilizumab mono-therapy in patients with large vessel vasculitis (LVV; giant cell arteritis or Takayasu arteritis) and polymyalgia rheumatica (PMR) |
| Date of disclosure of the study information | 2012/10/01 |
| Last modified on | 2018/08/09 14:22:31 |
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Basic information
Public title
Efficacy and safety of tocilizumab mono-therapy in patients with large vessel vasculitis (LVV; giant cell arteritis or Takayasu arteritis) and polymyalgia rheumatica (PMR)
Acronym
Treatment of LVV and PMR by tocilizumab mono-therapy
Scientific Title
Efficacy and safety of tocilizumab mono-therapy in patients with large vessel vasculitis (LVV; giant cell arteritis or Takayasu arteritis) and polymyalgia rheumatica (PMR)
Scientific Title:Acronym
Treatment of LVV and PMR by tocilizumab mono-therapy
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of tocilizumab monotherapy for LVV and PMR
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
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)
Key secondary outcomes
Improvement of major clinical signs at week 52, relapse rate and adverse events during 52 weeks
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
tocilizumab monotherapy
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 16 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key 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
Key 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
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Amano |
Organization
Saitama Medical Center,
Saitama Medical University
Division name
Department of Rheumatology and Clinical Immunology
Zip code
Address
1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan
TEL
049-228-3859
amanokoi@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryota Sakai |
Organization
Saitama Medical Center, Saitama Medical Universitity
Division name
Department of Rheumatology & Clinical Immunology
Zip code
Address
1981 Kamoda Kawagoe, Saitama 350-8550
TEL
0492283574
Homepage URL
r_sakai@saitama-med.ac.jp
Sponsor or person
Institute
Department of Rheumatology & Clinical Immunology
Saitama Medical Center, Saitama Medical Universitity
Institute
Department
Personal name
Funding Source
Organization
Department of Rheumatology & Clinical Immunology
Saitama Medical Center, Saitama Medical Universitity
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 30 | Day |
Last modified on
| 2018 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010359
