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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000006669
Receipt No. R000007876
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
Date of disclosure of the study information 2011/11/05
Last modified on 2014/05/04

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Basic information
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
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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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 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 093-603-1611
Email tanaka@med.uoeh-u.ac.jp

Public contact
Name of contact person Shintaro Hirata
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 093-603-1611
Homepage URL
Email s-hirata@med.uoeh-u.ac.jp

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

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
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
Nationality of Funding Organization

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

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

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

Related information
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.

Management information
Registered date
2011 Year 11 Month 04 Day
Last modified on
2014 Year 05 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007876


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