UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Follow-up study of patients with rheumatoid arthritis who treated infliximab for 1 year and did not reach a clinical remission in RRRR Study
Title of the study (Brief title)	Remission induction by Raising the dose of Remicade in RA Extension study (RRRR-EX Study)
Region	Japan

Condition
Condition	Rheumatoid Arthritis
Classification by specialty	Endocrinology and Metabolism Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate clinical remission in patients who continue treatment with IFX administration after failing to reach a clinical remission at 1 year treatment with IFX in RRRR Study
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Proportion of clinical remission 1 year after enrolling in RRRR-RX Study
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patients who did not reach a clinical remission at the time of 54 weeks from first administration of IFX in RRRR Study 2)Patients who continue treatment with IFX administration after failing to reach a clinical remission 3)Written informed consent
Key exclusion criteria	1)Patients who discontinued IFX treatment prior to 54 week from the first administration of IFX in the RRRR Study 2) Patients who are inadequate to enter this trial due to the other reasons by physician's judgments
Target sample size	108

Research contact person
Name of lead principal investigator	Yoshiya Tanaka
Organization	University of Occupational and Environmental Health, Japan
Division name	The First Department of Internal Medicine, School of Medicine
Address	1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, Japan
TEL	093-603-1611
Email	tanaka@med.uoeh-u.ac.jp

Public contact
Name of contact person	Nao Horie
Organization	Hokkaido University Hospital
Division name	Translational Research and Clinical Trial Center
Address	Nishi-5, Kita-14, Kita-ku, Sapporo, Hokkaido, Japan
TEL	011-706-7735
Homepage URL
Email	RRRR@pop.med.hokudai.ac.jp

Sponsor
Institute	University of Occupational and Environmental Health, Japan
Institute
Department

Funding Source
Organization	A Research Grant-In-Aid for Scientific Research from the Ministry of Health, Labor and Welfare of Japan (partly), Self funding
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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

産業医科大学(福岡県) 医療法人早石会早石病院(大阪府) 東京医科歯科大学(東京都) 長崎大学病院(長崎県) 東北大学病院(宮城県) 埼玉医科大学総合医療センター(埼玉県) 医療法人社団善仁会市民の森病院(宮崎県) 埼玉医科大学(埼玉県) 香川大学医学部(香川県) 財団法人天理よろづ相談所病院(奈良県) 横浜市立みなと赤十字病院(神奈川県) 青森県立中央病院(青森県) 名古屋大学医学部(愛知県) 牛尾整形外科(大阪府) 北海道大学病院(北海道) 久留米大学医療センター(福岡県) 順天堂大学医学部(東京都) 慶應義塾大学医学部(東京都) 京都大学医学部附属病院京都府) 松原メイフラワー病院(兵庫県) 医療法人社団順和会　京都下鴨病院(京都府) 日本赤十字社大阪赤十字病院(大阪府) 医療法人財団白十字会　佐世保中央病院(長崎県) 兵庫医科大学(兵庫県) 北里大学病院(東京都) 医療法人社団 協志会宇多津浜クリニック(香川県) 関西医科大学附属枚方病院(大阪府) 日本赤十字社松山赤十字病院(愛媛県)

Other administrative information
Date of disclosure of the study information	2012 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 03 Month 01 Day
Anticipated trial start date	2012 Year 04 Month 01 Day
Last follow-up date	2015 Year 11 Month 30 Day
Date of closure to data entry	2017 Year 10 Month 31 Day
Date trial data considered complete	2017 Year 11 Month 30 Day
Date analysis concluded	2018 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	prospective observational study

Management information
Registered date	2012 Year 03 Month 21 Day
Last modified on	2017 Year 09 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008853