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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003880
Receipt No. R000004668
Scientific Title Keeping cartilagious quality by adalimumab in patient with rheumatoid arthritis in Kansai area
Date of disclosure of the study information 2010/07/07
Last modified on 2012/11/28

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Basic information
Public title Keeping cartilagious quality by adalimumab in patient with rheumatoid arthritis in Kansai area
Acronym KABUKI study
Scientific Title Keeping cartilagious quality by adalimumab in patient with rheumatoid arthritis in Kansai area
Scientific Title:Acronym KABUKI 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 joint destruction in echo, X-rays,and biochemical study when patients with rheumatoid arthritis were given adalimumab. 24 weeks later, we divide the group of low disease activity into a group maintaining dosage interval and the group to extend by randomization. Also we conduct a change to other biological products or antirheumatic drug addition by randomization if subjects do not enter the low disease activity group. We evaluate those four groups at 48 weeks later.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Disease activity score 28 (DAS28), modified Health Assessment Questionnaire (mHAQ), Cartilage Oligometric Matrix Protein (COMP), Sharp score, Echo score
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 DAS28>3.2 at 24 weeks
Switching to another biologics
Interventions/Control_2 DAS28>3.2 at 24 weeks
Dose up of MTX or addition of other DMARDs
Interventions/Control_3 DAS28<=3.2 at 24 weeks
40 mg of Adalimumab every two week
Interventions/Control_4 DAS28<=3.2 at 24 weeks
40 mg of Adalimumab every four week
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 Rheumatoid arthritis patients who receive adalimumab under an adaptation of biologics
Key exclusion criteria A malignant tumor, a lymphoma, active tuberculosis, demyelinating disease, congestive heart failure
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuya Koike
Organization Osaka City University Medical School
Division name 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 Rheumatosurgery
Zip code
Address Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan
TEL 06-6645-3984
Homepage URL
Email tatsuya@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University Medical School
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Higashi Sumiyoshi Morimoto Hospital, Yodogawa Christian Hospital, Kitade Hospital, Shirahama Hamayu Hospital
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 東住吉森本病院(大阪府)、淀川キリスト教病院(大阪府)、北出病院(和歌山県)、白浜はまゆう病院(和歌山県)、公立山城病院(京都府)

Other administrative information
Date of disclosure of the study information
2010 Year 07 Month 07 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
2009 Year 10 Month 30 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
2014 Year 12 Month 31 Day
Date of closure to data entry
2015 Year 03 Month 31 Day
Date trial data considered complete
2015 Year 05 Month 31 Day
Date analysis concluded
2015 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2010 Year 07 Month 06 Day
Last modified on
2012 Year 11 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004668

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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