UMIN-CTR Clinical Trial

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
Email	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
Email	ayasuzu@med.uoeh-u.ac.jp

Sponsor
Institute	University of Occupational and Environmental Health, Japan
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007876