UMIN-CTR Clinical Trial


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Recruitment
status
F No longer recruiting
Unique trial Number : UMIN000006669
Title of the study : Discontinuation of adalimumab without functional and structural damage progression after attaining sustained remission in patients with rheumatoid arthritis: An observational study
Date of formal registration
(=Date of ICMJE and WHO compliant trial information registration and disclosure)
: 2011/11/05
Date and time of last update : 2011/11/04 11:52:42

¦ This page includes information on clinical trials registered in UMIN clinical trial registed system.
¦ We don't aim to advertise certain products or treatments.

Basic information
Item Value
Official scientific title of the study Discontinuation of adalimumab without functional and structural damage progression after attaining sustained remission in patients with rheumatoid arthritis: An observational study
Title of the study (Brief title) HUMIRA discontinuation withOut functional and radiographic damage progressioN follOwing sustained Remission in rheumatoid arthritis (HONOR study)
Region Japan


Condition
Item Value
Condition Rheumatoid Arthritis
Classification by specialty Medicine in general
Endocrinology and Metabolism
Clinical immunology
Classification by malignancy Others
Genomic information NO


Objectives
Item Value
Narrative objectives1 To evaluate disease activity, functional disability and radiographic damage progression after discontinuation of adalimumab in Japanese RA patients who achieved and maintained remission (DAS28-ESR <2.6) status for >24 weeks
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable


Assessment
Item Value
Primary outcomes The percentage of patients who maintained remission status at 24 weeks after discontinuation of adalimumab
Key secondary outcomes Percentages of patients who maintained low disease activity (DAS28-ESR <3.2), remission (DAS28-ESR <2.6), normal function (HAQ <0.5) and no structural damage (1-year change of mTSS <0.5) at 24/52 weeks after discontinuation of adalimumab


Base
Item Value
Study type Observational


Study design
Item Value
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment


Intervention
Item Value
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
Item Value
Age-lower limit 18 years-old <=
Age-upper limit Not applicable
Gender Male and Female
Key inclusion criteria 1) Diagnosed as rheumatoid arthritis, 2) sustained remission >24 weeks
Key exclusion criteria 1) Use of glucocorticoids for 24 weeks prior to discontinuation of adalimumab, 2) use of NSAIDs for 24 weeks prior to discontinuation of adalimumab, 3) severe infection, 4) active tuberculosis, 5) demyelinating disease (multiple sclerosis), 6) congestive heart failure, 7) Patient who is lactating, pregnant, possibly pregnant or do not agree with anti-conception during the trial and 6 months after the last administration of adalimumab, 8) patients who are inadequate to enter this trial due to the other reasons as judged by investigators
Target sample size 50


Research contact person
Item Value
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, Yahatanishi, Kitakyushu, Japan
TEL
Email


Public contact
Item Value
Name of contact person
Organization University of Occupational and Environmental Health, Japan
Division name The First Department of Internal Medicine, School of Medicine
Address
TEL +81-93-603-1611
Homepage URL
Email


Sponsor
Item Value
Name of primary sponsor University of Occupational and Environmental Health, Japan

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean "funding agency". Therefore, all clinical trial should have the one.


Funding Source
Item Value
Source of funding Research Grant-In-Aid for Scientific Research from the Ministry of Health, Labor and Welfare of Japan (partly), Self funding
Category of Org. MHLW(Japan)
Nation of funding


Other related organizations
Item Value
Name of secondary sponsor(s)
Name of secondary fun‚„er(s)


Secondary study IDs
Item Value
Secondary study IDs NO
Secondary study ID_1
Org. issuing Secondary study ID_1
Secondary study ID_2
Org. issuing Secondary study ID_2
IND to MHLW


Institutions
Item Value
Institutions ŽY‹Ζˆγ‰Θ‘εŠw/University of Occupational and Environmental Health, Japan


Progress
Item Value
Recruitment status No longer recruiting
Date of protocol fixation 2009/01/01
Anticipated trial start date 2009/02/01
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded


Related information
Item Value
URL releasing protocol
Publication of results partially published
URL releasing results
Results
Other related information We are currently observing patients targeting the percentage of patients who maintained remission status at 24 weeks after discontinuation of adalimumab as the primary endpoint and percentages of patients who maintained low disease activity (DAS28-ESR <3.2), remission (DAS28-ESR <2.6), normal function (HAQ <0.5) and no structural damage (yearly change of mTSS <0.5) at 24/52 weeks after discontinuation of adalimumab as the secondary endpoint.


Item Value
Date of registration 2011/11/05
Date of last update 2011/11/04 11:52:42


Link to view
URL(Japanese) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000007876&type=summary&language=J
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000007876&type=summary&language=E
¦ This page includes information on clinical trials registered in UMIN clinical trial registed system.
¦ We don't aim to advertise certain products or treatments.