UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010664 |
|---|---|
| Receipt number | R000012472 |
| Scientific Title | Clinical Research to examine the efficacy and safety of Certolizmab pegol |
| Date of disclosure of the study information | 2013/06/30 |
| Last modified on | 2018/03/12 07:44:50 |
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Basic information
Public title
Clinical Research to examine the efficacy and safety of Certolizmab pegol
Acronym
Clinical Research to examine the efficacy and safety of Certolizmab pegol
Scientific Title
Clinical Research to examine the efficacy and safety of Certolizmab pegol
Scientific Title:Acronym
Clinical Research to examine the efficacy and safety of Certolizmab pegol
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this research is to clear the efficacy and safety of Certolizmab pegol in the practical medical exam in Japan
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of the subjects who achieved the remission of DAS28-ESR/CRP at the point of W24
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)The patient who is diagnosed as rheumatoid arthritis according to ACR criteria in 1987 or ACR/EULAR new classification criteria in 2010.
2)The patient falling under any of a) or b).
a)The patient who is on CZP administration.
b)The patient whose doctor is planning novel CZP administration
3)The patient who obtained a written consent.
Key exclusion criteria
none
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masakazu Kondo |
Organization
The Fukuoka RA Biologics Registry
Division name
office
Zip code
Address
Tenjin 3-10-11, Chuou-ku, Fukuoka-shi, Fukuoka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The Fukuoka RA Biologics Registry
Division name
office
Zip code
Address
Tenjin 3-10-11, Chuou-ku, Fukuoka-shi, Fukuoka
TEL
Homepage URL
Sponsor or person
Institute
The Fukuoka RA Biologics Registry
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharma Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
UCB Japan Co.,Ltd.
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
| 2013 | Year | 06 | Month | 30 | 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
Completed
Date of protocol fixation
| 2013 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective study
Management information
Registered date
| 2013 | Year | 05 | Month | 08 | Day |
Last modified on
| 2018 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012472
