UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006669 |
|---|---|
| Receipt number | R000007876 |
| Scientific Title | Discontinuation of adalimumab without functional and structural damage progression after attaining sustained remission in patients with rheumatoid arthritis: An observational study |
| Date of disclosure of the study information | 2011/11/05 |
| Last modified on | 2022/02/16 09:47:08 |
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Basic information
Public title
Discontinuation of adalimumab without functional and structural damage progression after attaining sustained remission in patients with rheumatoid arthritis: An observational study
Acronym
HUMIRA discontinuation withOut functional and radiographic damage progressioN follOwing sustained Remission in rheumatoid arthritis (HONOR study)
Scientific Title
Discontinuation of adalimumab without functional and structural damage progression after attaining sustained remission in patients with rheumatoid arthritis: An observational study
Scientific Title:Acronym
HUMIRA discontinuation withOut functional and radiographic damage progressioN follOwing sustained Remission in rheumatoid arthritis (HONOR study)
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
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
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) 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
Name of lead principal investigator
| 1st name | Yoshiya |
| Middle name | |
| Last name | Tanaka |
Organization
University of Occupational and Environmental Health, Japan
Division name
The First Department of Internal Medicine, School of Medicine
Zip code
807-8555
Address
1-1, Iseigaoka, Yahatanishi, Kitakyushu, Japan
TEL
093-603-1611
tanaka@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Ayako |
| Middle name | |
| Last name | Yamaguchi |
Organization
University of Occupational and Environmental Health, Japan
Division name
The First Department of Internal Medicine, School of Medicine
Zip code
807-8555
Address
1-1, Iseigaoka, Yahatanishi, Kitakyushu, Japan
TEL
093-603-1611
Homepage URL
ayasuzu@med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
Funding Source
Organization
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
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Occupational and Environmental Health, Japan
Address
1-1, Iseigaoka, Yahatanishi, Kitakyushu, Japan
Tel
093-603-1611
tanaka@med.uoeh-u.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
産業医科大学/University of Occupational and Environmental Health, Japan
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2009 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2010 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2009 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2019 | Year | 08 | Month | 01 | Day |
Other
Other related information
We are currently observing patients targeting the percentage of patients who maintained remission status at 24,52 weeks and 5-years 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 and 5-years after discontinuation of adalimumab as the secondary endpoint.
Management information
Registered date
| 2011 | Year | 11 | Month | 04 | Day |
Last modified on
| 2022 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007876
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