Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
JPRN |
Last refreshed on:
|
17 October 2023 |
Main ID: |
JPRN-UMIN000012072 |
Date of registration:
|
01/12/2013 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
Public title:
|
A prospective, open label, single arm, historical control trial of tocilizumab with corticosteroids in patients with microscopic polyangiitis
|
Scientific title:
|
A prospective, open label, single arm, historical control trial of tocilizumab with corticosteroids in patients with microscopic polyangiitis - Tocilizumab with corticosteroids in microscopic polyangiitis |
Date of first enrolment:
|
2013/12/01 |
Target sample size:
|
20 |
Recruitment status: |
Complete: follow-up complete |
URL:
|
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014111 |
Study type:
|
Interventional |
Study design:
|
Single arm Non-randomized
|
Phase:
|
Phase III
|
|
Countries of recruitment
|
Japan
| | | | | | | |
Contacts
|
Name:
|
Koichi Amano |
Address:
|
1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan
Japan |
Telephone:
|
0492283859 |
Email:
|
amanokoi@saitama-med.ac.jp |
Affiliation:
|
Saitama Medical Center, Saitama Medical University Department of Rheumatology and Clinical Immunology |
|
Name:
|
Ryota Sakai |
Address:
|
1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan
Japan |
Telephone:
|
0492283574 |
Email:
|
r_sakai@saitama-med.ac.jp |
Affiliation:
|
Saitama Medical Center, Saitama Medical University Department of Rheumatology and Clinical Immunology |
| |
Key inclusion & exclusion criteria
|
Inclusion 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 tocilizumab by their attending doctor
Age minimum:
20years-old
Age maximum:
80years-old
Gender:
Male and Female
|
Health Condition(s) or Problem(s) studied
|
Microscopic polyangiitis
|
Intervention(s)
|
Tocilizumab group
|
Primary Outcome(s)
|
Improvement of major clinical signs and symptoms at week 24. (MPO-ANCA or PR3-ANCA, serum CRP and ESR, BVAS2003, VDI)
|
Secondary Outcome(s)
|
Improvement of major clinical signs and symptoms at week 52. Relapse rate at week 104.
|
Source(s) of Monetary Support
|
Department of Rheumatology & Clinical Immunology Saitama Medical Center, Saitama Medical Universitity
|
Ethics review
|
Status: YES
Approval date:
Contact:
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|