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UMIN-CTR Clinical Trial |
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Name | UMIN ID |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000005570 |
Receipt No. | 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 |
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 |
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Condition | |||
Condition | Rheumatoid arthritis | ||
Classification by specialty |
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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 | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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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 |
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Organization | Osaka City University Medical School | ||||||
Division name | Dept. of orthopaedic surgery | ||||||
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TEL | |||||||
Homepage URL | |||||||
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 | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
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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 |
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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 |
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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 |
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Last modified on |
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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 |