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


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 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


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

Value
https://center6.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