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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005113
Receipt No. R000006076
Scientific Title Evaluation of the clinical remission and its sustainment after discontinuation of infliximab in patients with rheumatoid arthritis who receive "programmed" treatment in randomized controlled trial
Date of disclosure of the study information 2011/03/31
Last modified on 2019/03/25

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Basic information
Public title Evaluation of the clinical remission and its sustainment after discontinuation of infliximab in patients with rheumatoid arthritis who receive "programmed" treatment in randomized controlled trial
Acronym Remission induction by Raising the dose of Remicade in RA study (RRRR Study)
Scientific Title Evaluation of the clinical remission and its sustainment after discontinuation of infliximab in patients with rheumatoid arthritis who receive "programmed" treatment in randomized controlled trial
Scientific Title:Acronym Remission induction by Raising the dose of Remicade in RA study (RRRR 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 To evaluate the frequency of clinical remission and its sustainment after discontinuation of infliximab (IFX) in methotrexate-refractory patients with rheumatoid arthritis who receive "programmed" treatment (programmed treatment arm), whose dose of IFX for each patient is determined by the baseline tumor necrosis factor-alpha (TNF-alpha) level, compared with patients who receive a "standard" treatment (standard treatment arm), whose dose was fixed as 3mg/kg every 8 weeks, as a control in a prospective randomized controlled trial.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Proportion of patients maintaining discontinuation of IFX at 1 year after a discontinuation of IFX at the time of 54 weeks after the first administration of IFX
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 "programmed" treatment (Programmed treatment arm), whose dose of IFX for each patient is determined by the baseline TNF-alpha level
IFX 3mg/kg is administered on week 0, 2 and 6. After week 14, dose of IFX for each patient is determined by the baseline TNF-alpha level as follows;
TNF-alpha < 0.55pg/mL: IFX 3mg/kg is continued every 8 weeks.
0.55pg/mL =< TNF-alpha < 1.65pg/mL: IFX 6mg/kg is administered on week 14. IFX 6mg/kg is continued every 8 weeks.
TNF-alpha >= 1.65pg/mL: IFX 6mg/kg is administered on week 14 and IFX 10mg/kg is administered on week 22. IFX 10mg/kg is continued every 8 weeks.
In all cases, IFX is discontinued at the time of 54 weeks after the first administration of IFX.
Interventions/Control_2 "standard" treatment (standard treatment arm), whose dose was fixed as 3mg/kg every 8 weeks
IFX 3mg/kg is administered on week 0, 2 and 6. After week 14, IFX 3mg/kg is continued every 8 weeks. IFX is discontinued at the time of 54 weeks after the first administration of IFX.
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) rheumatoid arthritis, 2) refractory patients despite methotrexate, 3) patients who have never treated with IFX, 4) written informed consent
Key exclusion criteria 1) patients who use steroid over 10mg/day (prednisolone-equivalent), 2) SDAI =< 11.0, 3) severe infection, 4) active tuberculosis, 5) demyelinating disease, 6) congestive heart failure, 7) Patient who is lactating, pregnant, possibly pregnant or do not agree with anti-conception during the trial and 6 month after the last administration of IFX, 8) patients who are inadequate to enter this trial due to the other reasons by physician's judgments
Target sample size 450

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiya Tanaka
Organization University of Occupational and Environmental Health, Japan
Division name The First Department of Internal Medicine, School of Medicine
Zip code
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
1st name
Middle name
Last name Nao Horie
Organization Hokkaido University Hospital
Division name Translational Research and Clinical Trial Center
Zip code
Address Nishi-5, Kita-14, Kita-ku, Sapporo, Hokkaido, Japan
TEL 011-706-7735
Homepage URL
Email nhorie@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)

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 産業医科大学(福岡県)・早石会早石病院(大阪府)・東京医科歯科大学(東京都)・千葉大学医学部付属病院(千葉県)・長崎大学病院(長崎県)・東北大学病院(宮城県)・埼玉医科大学病院総合医療センター(埼玉県)・青梅市総合病院(東京都)・善仁会市民の森病院(宮崎県)・市立札幌病院(北海道)・北海道内科リウマチ科病院(北海道)・埼玉医科大学(埼玉県)・弘前大学医学部付属病院(青森県)・天理よろづ相談所病院(奈良県)・島根大学医学部付属病院(島根県)・東京大学医学部付属病院(東京都)・横浜市立みなと赤十字病院(神奈川県)・川崎市立川崎病院(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)・本荘リウマチクリニック(富山県)・久留米大学医療センター(福岡県)・筑波大学附属病院(茨城県)・順天堂大学(東京都)・愛知医科大学病院(愛知県)・鹿児島赤十字病院(鹿児島県)・慶應義塾大学(東京都)・山形大学医学部附属病院(山形県)・昭和大学病院(東京都)・横浜南共済病院(神奈川県)・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)・宇多野病院(京都府)・京都下鴨病院(京都府)・市立長浜病院(滋賀県)・大阪赤十字病院(大阪府)・日本赤十字社和歌山医療センター(和歌山県)・佐世保中央病院(長崎県)・兵庫医科大学(兵庫県)・宇多津浜クリニック(香川県)・名古屋市立大学病院(愛知県)・北里大学病院(神奈川県)・藤田保健衛生大学(愛知県)・・高知大学 医学部(高知県)・関西医科大学付属枚方病院(大阪府)・国立病院機構千葉東病院(千葉県)・岡山大学病院(岡山県)・広島大学病院(広島県)

Other administrative information
Date of disclosure of the study information
2011 Year 03 Month 31 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
2011 Year 02 Month 17 Day
Date of IRB
2011 Year 03 Month 07 Day
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
2016 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2011 Year 02 Month 21 Day
Last modified on
2019 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006076

Research Plan
Registered date File name

Research case data specifications
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Research case data
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