UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008164 |
|---|---|
| Receipt number | R000009616 |
| Scientific Title | Restart for sustaining remission of rheumatoid arthritis in use of etanercept |
| Date of disclosure of the study information | 2012/06/13 |
| Last modified on | 2022/01/10 10:35:19 |
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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
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
tatsuya@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009616
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
