UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Registry of the patients with rheumatoid arthritis treated with Biologics in routine clinical practice.
Title of the study (Brief title)	FRAB Registry
Region	Japan

Condition
Condition	Rheumatoid Arthritis
Classification by specialty	Medicine in general Clinical immunology Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate of the drug survival, clinical response and remission in patients with RA treated in clinical practice with Biologics.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Clinical remission rate
Key secondary outcomes	Continuation rate, time course of DAS-ESR, incidence rate and type of adverse events.

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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Fulfill the 1987 ACR or 2010 ACR/EULAR classification criteria for RA. 2)RA patients who treated in biologics ( Tocilizumab, Infliximab, Etanercept, Adalimumab, Abatacept, and Golimumab) at clinical practice. 3)Patients who obtains agreement for participation in present this study.
Key exclusion criteria	When a patient is regarded as inappropriate to join the study by physicians' discretion When a patient withdraw consent to this study
Target sample size	2000

Research contact person
Name of lead principal investigator	Masakazu Kondo
Organization	Kondo Clinic of Rheumatology and Orthopaedic Surgery
Division name	Kondo Clinic of Rheumatology and Orthopaedic Surgery
Address	3-10-11 Tenjin, chuou-ku, Fukuoka,
TEL	092-762-2380
Email	yasunaka@ortho.med.kyushu-u.ac.jp

Public contact
Name of contact person	Yasuharu Nakashima
Organization	Kyushu University
Division name	Department of Orthopaedic Surgery
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka,
TEL	092-642-5487
Homepage URL
Email	yasunaka@ortho.med.kyushu-u.ac.jp

Sponsor
Institute	FRAB Registry
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kondo Clinic of Rheumatology,Kyushu University,Fukuoka University,Kyushu Medical Center, etc
Name of secondary funｄer(s)

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	2012 Year 02 Month 03 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2008 Year 04 Month 01 Day
Anticipated trial start date	2008 Year 04 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	To investigate of efficacy and safety in patients with RA treated in clinical practice with Biologics.

Management information
Registered date	2012 Year 02 Month 03 Day
Last modified on	2017 Year 03 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008507