UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018659 |
|---|---|
| Receipt number | R000021604 |
| Scientific Title | Inhibitory effects of tocilizumab on serum oxidative stress in patients with rheumatoid arthritis -comaparison with other biologic agents- |
| Date of disclosure of the study information | 2015/08/13 |
| Last modified on | 2015/08/12 23:43:50 |
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Basic information
Public title
Inhibitory effects of tocilizumab on serum oxidative stress in patients with rheumatoid arthritis -comaparison with other biologic agents-
Acronym
Inhibitory effects of tocilizumab on serum oxidative stress in patients with RA
Scientific Title
Inhibitory effects of tocilizumab on serum oxidative stress in patients with rheumatoid arthritis -comaparison with other biologic agents-
Scientific Title:Acronym
Inhibitory effects of tocilizumab on serum oxidative stress in patients with RA
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether tocilizumab decreases serum reactive oxygen metabolities (ROM) and compare its effects with other biologic agents
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum levels of ROM, CRP, MMP3, and DAS28 twenty-four weeks after tocilizumab or other biologics administration
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. RA patients on moderate or high disease activity
2. Biologics-naive patients
Key exclusion criteria
1. RA patients on remission or low disease activity
2. Patients who have recieved biologic agents
3. Patients who have suffered from severe infection disease or have high risk factors
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Arata Nakajima |
Organization
Toho University Sakura Medical Center
Division name
Orthopedics
Zip code
Address
564-1 Shimoshizu, Sakura-shi, Chiba 285-8741
TEL
043-462-8811
arata.nakajima@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Arata Nakajima |
Organization
Toho University Sakura Medical Center
Division name
Orthopedics
Zip code
Address
564-1 Shimoshizu, Sakura-shi, Chiba 285-8741
TEL
043-462-8811
Homepage URL
arata.nakajima@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Chugai pharmaceutical company
Organization
Division
Category of Funding Organization
Profit organization
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
| 2015 | Year | 08 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | 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
This study is an observational study to investigate serum oxidative stress in addition to routine laboratory examinations and clinical evaluation for the treatment of rheumatoid arthritis.
Management information
Registered date
| 2015 | Year | 08 | Month | 12 | Day |
Last modified on
| 2015 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021604
