UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014934 |
|---|---|
| Receipt number | R000017249 |
| Scientific Title | A study for effectiveness and safety of tocilizumab therapy in rheumatoid arthritis patients with renal insufficiency. |
| Date of disclosure of the study information | 2014/08/25 |
| Last modified on | 2017/01/18 12:41:06 |
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Basic information
Public title
A study for effectiveness and safety of tocilizumab therapy in rheumatoid arthritis patients with renal insufficiency.
Acronym
Tocilizumab for rheumatoid arthritis patients with renal insufficiency
Scientific Title
A study for effectiveness and safety of tocilizumab therapy in rheumatoid arthritis patients with renal insufficiency.
Scientific Title:Acronym
Tocilizumab for rheumatoid arthritis patients with renal insufficiency
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate effctiveness and safey of tocilizumab therapy in treating rheumatoid arthritis patients with renal insufficiency
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Changes in CDAI values after the 24-week treatment with tocilizumab
Key secondary outcomes
Improvement of anemia after the 24-week treatment with tocilizumab
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All patients with rheumatoid arthritis who were treated with tocilizumab in participating hospitals.
Key exclusion criteria
None
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunsuke Mori |
Organization
NHO Kumamoto Saishunsou National Hospital
Division name
Research Center for Rheumatic Diseases
Zip code
Address
2659 Suya, Kohshi, Kumamoto, Japan
TEL
81-96-242-1000
moris@saisyunsou1.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinji Furukawa |
Organization
NHO Kumamoto Saishunsou National Hospital
Division name
Secretariat
Zip code
Address
2659 Suya, Kohshi, Kumamoto, Japan
TEL
81-96-242-1000
Homepage URL
8211sy01@hosp.go.jp
Sponsor or person
Institute
NHO Kumamoto Saishunsou National Hospital
Institute
Department
Personal name
Funding Source
Organization
NHO Kumamoto Saishunsou National Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Sasebo Chuo Hospital
Shimin-no-Mori Hospital
Yoshitama Clinic for Rheumatic Diseases
Name of secondary funder(s)
Chugai Pharmaceutical Co.
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
国立病院機構熊本再春荘病院（熊本県）、佐世保中央病院（長崎県）、市民の森病院（宮崎県）、吉玉リウマチ科内科（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
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
Main results already published
Date of protocol fixation
| 2014 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 29 | Day |
Date of closure to data entry
| 2015 | Year | 09 | Month | 29 | Day |
Date trial data considered complete
| 2015 | Year | 09 | Month | 29 | Day |
Date analysis concluded
| 2015 | Year | 09 | Month | 29 | Day |
Other
Other related information
Main outcome measures
CDAI and Hb
Secondary measures
Severe adverse effect
Base line Characteristis
Age, Sex, RA stage, RA class, ACPA, RF, Height, Body weight, serum Cr, Previous biologics, Concomitant used drugs, Hypertention, NIDDM
Management information
Registered date
| 2014 | Year | 08 | Month | 24 | Day |
Last modified on
| 2017 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017249
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
