UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004137 |
|---|---|
| Receipt number | 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 07:03:45 |
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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
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
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004969
