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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010664
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute The Fukuoka RA Biologics Registry
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012472

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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