UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical Research to examine the efficacy and safety of Certolizmab pegol
Title of the study (Brief title)	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	Masakazu Kondo
Organization	The Fukuoka RA Biologics Registry
Division name	office
Address	Tenjin 3-10-11, Chuou-ku, Fukuoka-shi, Fukuoka
TEL
Email

Public contact
Name of contact person
Organization	The Fukuoka RA Biologics Registry
Division name	office
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.

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 02 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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