UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	postmarketing surveillance For Investigating success in achieving clinical and functional Remission and Sustaining efficacy with Tocilizumab in BIOlogics naive RA patients
Title of the study (Brief title)	FIRST-BIO study
Region	Japan

Condition
Condition	Patients with rheumatoid arthritis who have been diagnosed based on the 2010 ACR/EULAR new classification criteria for RA Patients who have no previous medical history of biological agents for RA Patients whose disease activity is DAS28>=3.2 at baseline
Classification by specialty	Clinical immunology Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the benefit of tocilizumab (TCZ) in the early diagnosed, biologics therapy naive patients in the real clinical practice.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Percentage of patients achieving remission by the new ACR/EULAR Boolean based criteria at week 52. (Comparing the remission rate by disease duration)
Key secondary outcomes	Adverse reaction incidence

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	Rheumatoid arthritis diagnosed by ACR/EULAR new classification criteria for RA. Biological drug treatment naive. Moderate to high disease activity (DAS28>=3.2) at baseline.
Key exclusion criteria	No criteria
Target sample size	700

Research contact person
Name of lead principal investigator	Joji Mochizuki
Organization	Chugai Pharmaceutical Co. Ltd.
Division name	Pharmacovigilance Dept.
Address	1-1 Muromachi 2-Chome, Chuo-ku Tokyo, JAPAN
TEL	03-3273-0905
Email	mochizukijuj@chugai-pharm.co.jp

Public contact
Name of contact person	Makoto Nomura
Organization	Chugai Pharmaceutical Co. Ltd.
Division name	Pharmacovigilance Dept.
Address	1-1 Muromachi 2-Chome, Chuo-ku Tokyo, JAPAN
TEL	03-3273-0905
Homepage URL
Email	nomuramkt@chugai-pharm.co.jp

Sponsor
Institute	Chugai Pharmaceutical Co. Ltd.
Institute
Department

Funding Source
Organization	Chugai Pharmaceutical Co. Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	2011 Year 12 Month 22 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 11 Month 14 Day
Anticipated trial start date	2012 Year 01 Month 01 Day
Last follow-up date	2014 Year 09 Month 29 Day
Date of closure to data entry	2014 Year 09 Month 29 Day
Date trial data considered complete	2016 Year 05 Month 11 Day
Date analysis concluded	2016 Year 06 Month 23 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	Tender joint count, Swollen joint count, Patient global assessment on VAS, Physician global assessment on VAS, ESR, C-reactive protein and Rheumatoid factor, HAQ

Management information
Registered date	2011 Year 12 Month 20 Day
Last modified on	2018 Year 01 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008172