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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004137
Receipt No. R000004969
Scientific Title Orencia remission Induction and Outcome Navigation Study
Date of disclosure of the study information 2010/09/01
Last modified on 2013/11/30

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Basic information
Public title Orencia remission Induction and Outcome Navigation Study
Acronym ORION Study
Scientific Title Orencia remission Induction and Outcome Navigation Study
Scientific Title:Acronym ORION Study
Region
Japan

Condition
Condition rheumatoid arthritis
Classification by specialty
Endocrinology and Metabolism Clinical immunology Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the sustained efficacy after discontinuation of abatacept in rheumatoid arthritis with DAS28-CRP under 2.3.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase IV

Assessment
Primary outcomes Rate of the discontinuation of abatacept at one year after discontinuation of abatacept
Key secondary outcomes 1) Change in remission rate (DAS28-CRP)
2) X ray
3) Change in HAQ
4) The mean of re-administration time
5) Stratified analysis of remission conditions
6) Efficacy and safety of re-administration of abatacept after recurrence

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients who give a full consent to this study
2) Patients with rheumatoid arthritis having joined in studies IM101071 and IM101129 and treated with abatacept at entry.
3) Patients whose DAS28-CRP is less than 2.3 at the time of entry
Key exclusion criteria Patients who are inadequate by investigator 's decision
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsutomu Takeuchi
Organization Department of Internal Medicine, Keio University School of Medicine
Division name Division of Rheumatology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Keio University School of Medicine
Division name Center for Clinical research
Zip code
Address
TEL 03-5363-3288
Homepage URL
Email

Sponsor
Institute Keio University
Institute
Department

Funding Source
Organization Bristol-Myers Squibb
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 北海道大学病院(北海道)、市立札幌病院(北海道)、太白さくら病院(宮城県)、東北大学病院(宮城県)、筑波大学附属病院(茨城県)、多賀総合病院(茨城県)、埼玉医科大学病院(埼玉県)、埼玉医科大学総合医療センタ-(埼玉県)、北里研究所メディカルセンター病院(埼玉県)、東京女子医科大学(東京都)、東京医科歯科大学(東京都)、 
国立病院機構相模原病院(神奈川県)、国立病院機構千葉東病院(千葉県)総合病院聖隷浜松病院(静岡県)福井総合クリニック(福井県)、福井温泉病院(福井県)、国立病院機構名古屋医療センター(愛知県)、国立病院機構大阪南医療センター(大阪府)、松原メイフラワ-病院(兵庫県)、 兵庫医科大学病院(兵庫県)、国立病院機構南岡山医療センター(岡山県)、東広島記念病院(広島県)、産業医科大学病院(福岡県)、
国立病院機構九州医療センタ- (福岡県)、ピーエスクリニック内科(福岡県)、国立病院機構嬉野医療センター(佐賀県)

Other administrative information
Date of disclosure of the study information
2010 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

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
2010 Year 06 Month 10 Day
Date of IRB
Anticipated trial start date
2010 Year 09 Month 01 Day
Last follow-up date
2012 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2012 Year 07 Month 01 Day

Other
Other related information Objective: To assess the sustained efficacy after discontinuation of abatacept.
Design : prospective observational study
Sampling: Patients with rheumatoid arthritis having joined in studies IM101071 and IM101129 and DAS28-CRP under 2.3.

Management information
Registered date
2010 Year 08 Month 31 Day
Last modified on
2013 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004969

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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