UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005570 |
|---|---|
| Receipt number | R000006594 |
| Scientific Title | Can abatacept induce immunological remission under tight control in rheumatoid arthritis patient? |
| Date of disclosure of the study information | 2011/06/01 |
| Last modified on | 2012/11/28 21:29:52 |
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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
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
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
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
tatsuya@med.osaka-cu.ac.jp
Sponsor or person
Institute
Department of Rheumatosurgery, Osaka City University Medical School
Institute
Department
Personal name
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
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
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
Plan to share IPD
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006594
