UMIN-CTR Clinical Trial

Basic information
Public title	Can abatacept induce immunological remission under tight control in rheumatoid arthritis patient?
Acronym	Airtight study
Scientific Title	Can abatacept induce immunological remission under tight control in rheumatoid arthritis patient?
Scientific Title:Acronym	Airtight study
Region	Japan

Condition
Condition	Rheumatoid arthritis
Classification by specialty	Clinical immunology Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine whether abatacept brings immunological remission to patients with rheumatoid arthritis under the environment where disease activity is controlled tightly.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase IV

Assessment
Primary outcomes	Changes in values of anti-cyclic citrullinated peptide antibody, rheumatoid factor, IgG that lack galactose, and type IgG rheumatoid factor
Key secondary outcomes	Scores in joint echo for hand and wrist

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
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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	Patients who had a diagnosis by 2010 ACR/EULAR rheumatoid arthritis classification criteria and then will receive one of biological agents Including patients with switching of biologic agents
Key exclusion criteria	Patients with leukocyte less than 4000/mm3, lymphocytes 1000/mm3, ADL activity in class IV, interstitial pneumonia, active hepatitis B, active tuberculosis, compromised condition, malignant tumor
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tatsuya Koike
Organization	Osaka City University Medical School
Division name	Department of Rheumatosurgery
Zip code
Address	Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan
TEL	06-6645-3984
Email

Public contact
Name of contact person	1st name Middle name Last name Tatsuya Koike
Organization	Osaka City University Medical School
Division name	Dept. of orthopaedic surgery
Zip code
Address
TEL
Homepage URL
Email	tatsuya@med.osaka-cu.ac.jp

Sponsor
Institute	Department of Rheumatosurgery, Osaka City University Medical School
Institute
Department

Funding Source
Organization	Department of Rheumatosurgery, Osaka City University Medical School
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
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IRB Contact (For public release)
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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	大阪市立大学医学部附属病院（大阪）、東住吉森本病院(大阪）、北出病院（和歌山）、白浜はまゆう病院（和歌山）、大東中央病院(大阪）、十三市民病院（大阪）、藤井寺市民病院（大阪）

Other administrative information
Date of disclosure of the study information	2011 Year 06 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
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IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2011 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date	2011 Year 05 Month 01 Day
Last follow-up date	2014 Year 04 Month 01 Day
Date of closure to data entry	2014 Year 07 Month 01 Day
Date trial data considered complete	2014 Year 10 Month 01 Day
Date analysis concluded	2014 Year 12 Month 01 Day

Other

Other related information

Before and after one year of administration of biologic agents we perform the immunological tests such as anti-CCP antibodies to patients with rheumatoid arthritis who will receive biologics after May, 2011. Because there is a case which synovial local activity cannot be controlled even if it is the patients who arrived at the clinical remission, we perform the joint echo on hands and do it with the help of the judgment of the remission.

Management information
Registered date	2011 Year 05 Month 08 Day
Last modified on	2012 Year 11 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006594

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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