UMIN-CTR Clinical Trial

Basic information
Public title	Restart for sustaining remission of rheumatoid arthritis in use of etanercept
Acronym	RESUME
Scientific Title	Restart for sustaining remission of rheumatoid arthritis in use of etanercept
Scientific Title:Acronym	RESUME
Region	Japan

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

Objectives
Narrative objectives1	To reveal the efficacy of short-term and intermittent administration of etanercept for the control of disease activity and the prevention of joint destruction in patients with rheumatoid arthritis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase IV

Assessment
Primary outcomes	The rate of change of modified Sharp score at 24 months
Key secondary outcomes	1. The rate of change of DAS28 at 24 months 2. The rate of change of modified HAQ at 24 months 3. Safety profile

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	After the administration of etanercept (50mg/week), the dosage of etanercept will be discontinued when the low disease activity (DAS28-ESR<3.2) is achieved. If patients recur from low disease activity, same dose of etanercept will be administered again by the observation of every two months. This strategy will be maintained for two years. We must control the disease activity below the low disease activity using combined medicine except glucocorticoid if patients could not reach low disease activity after the administration of etanercept in three months. It will be considered to be a dropout if patients cannot reach low disease activity within six months.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. The patients who meet 2010 ACR/EULAR classification criteria 2. The patients receiving MTX more than three months 3. The patients with moderate or severe disease activity (DAS28-ESR>3.2)
Key exclusion criteria	1. The patients with severe joint destruction of hands and feet because the evaluation of Sharp score will be impossible 2.The patients who take tacrolimus 3.The patients receiving glucocorticoid over 5mg/day
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Tatsuya Middle name Last name Koike
Organization	Osaka City University Medical School
Division name	Department of Rheumatosurgery
Zip code	545-8585
Address	Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan
TEL	+81-6-6645-3984
Email	tatsuya@med.osaka-cu.ac.jp

Public contact
Name of contact person	1st name Tatsuya Middle name Last name Tatsuya Koike
Organization	Osaka City University Medical School
Division name	Rheumatosurgery
Zip code	545-8585
Address	Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan
TEL	+81-6-6645-3984
Homepage URL
Email	tatsuya@med.osaka-cu.ac.jp

Sponsor
Institute	Osaka City University Medical School
Institute
Department

Funding Source
Organization	Osaka City University Medical School
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka City University Medical School
Address	Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan
Tel	06-6645-3851
Email	tatsuya@med.osaka-cu.ac.jp

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	大阪市立大学医学部附属病院(大阪）、東住吉森本病院(大阪）、野上病院(大阪）、大阪市総合医療センター(大阪）、藤井寺市民病院(大阪）、白浜はまゆう病院(和歌山）、北出病院(和歌山）、十三市民病院(大阪）、和泉市民病院(大阪）、淀川キリスト教病院)大阪）、大東中央病院(大阪）、上山病院(大阪）、柏原市民病院(奈良）

Other administrative information
Date of disclosure of the study information	2012 Year 06 Month 13 Day

Related information
URL releasing protocol	http://www.med.osaka-cu.ac.jp/orthoped/research/
Publication of results	Published

Result
URL related to results and publications	http://dx.doi.org/10.1097/MD.0000000000012462
Number of participants that the trial has enrolled	31
Results	All 13 patients achieved LDA at final follow-up. Although joint damage progressed in patients using ETN on-demand, structural damage progression in the on-demand group was not significantly different from that in controls. On-demand use of ETN for flaring reduced disease activity but not structural damage in 50% of patients (though not significantly). However, inhibition of joint damage was achieved in 50% of patients after 2 years.
Results date posted	2022 Year 01 Month 10 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	as mentioned above in RESUTS section
Participant flow	Thirty-one bDMARD-naive RA patients with moderate to high disease activity received ETN until low disease activity (LDA) was achieved, after which ETN was discontinued. Upon flaring, ETN was readministered with observation every 2 months for 2 years, and radiographically evaluated in comparison with a historical control group treated continuously with ETN.
Adverse events	as mentioned above in RESUTS section
Outcome measures	as mentioned above in RESUTS section
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2010 Year 10 Month 29 Day
Date of IRB	2010 Year 12 Month 06 Day
Anticipated trial start date	2011 Year 02 Month 01 Day
Last follow-up date	2014 Year 12 Month 01 Day
Date of closure to data entry	2015 Year 03 Month 01 Day
Date trial data considered complete	2015 Year 05 Month 01 Day
Date analysis concluded	2015 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date	2012 Year 06 Month 13 Day
Last modified on	2022 Year 01 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009616