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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000512
Receipt No. R000000620
Scientific Title Efficacy of tacrolimus in rheumatoid arthritis patients who have been treated unsuccessfully with infliximab and methotrexate
Date of disclosure of the study information 2006/11/03
Last modified on 2012/11/28

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Basic information
Public title Efficacy of tacrolimus in rheumatoid arthritis patients who have been treated unsuccessfully with infliximab and methotrexate
Acronym Combination therapy with Methotrexate, Infliximab, and Tacrolimus (COMMIT project)
Scientific Title Efficacy of tacrolimus in rheumatoid arthritis patients who have been treated unsuccessfully with infliximab and methotrexate
Scientific Title:Acronym Combination therapy with Methotrexate, Infliximab, and Tacrolimus (COMMIT project)
Region
Japan

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

Objectives
Narrative objectives1 To assess the efficacy, safety of tacrolimus for rheumatoid arthritis patiens who have been treated unsuccessfully with infliximab and methotrexate.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes DAS28
Key secondary outcomes ACR definition of improvement, CRP, Adverse events

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 If the score of DAS28 is under 3.2 in rheumatoid arthritis patients who have received infliximab and methotrexate, doses of methotrexate will reduced to 2mg/w. When the score of DAS28 increses, tacrolimus will be administered instead of methotrexate. Period of observation is 32 weeks.
Interventions/Control_2 If the score of DAS28 is over 3.2 in rheumatoid arthritis patients who have received infliximab and methotrexate, tacrolimus will be administered. Period of observation is 32 weeks.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Rheumatoid arthritis patients who have been treated with methotrexate and infliximab for over 22 weeks
Key exclusion criteria Dose of predonisone is over 5mg/day, patients who cannot receive tacrolimus
Target sample size 30

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 06-6645-3851
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yuko Sugioka
Organization Osaka City University Medical School
Division name Orthopaedic Surgery
Zip code
Address Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan
TEL 06-6645-3851
Homepage URL
Email tatsuya@med.osaka-cu.ac.jp

Sponsor
Institute Rheumatosurgery, Osaka City University Medical School
Institute
Department

Funding Source
Organization Tanabe Seiyaku Co. Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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

Other administrative information
Date of disclosure of the study information
2006 Year 11 Month 03 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2006 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2006 Year 10 Month 01 Day
Last follow-up date
2009 Year 01 Month 01 Day
Date of closure to data entry
2009 Year 03 Month 01 Day
Date trial data considered complete
2009 Year 04 Month 01 Day
Date analysis concluded
2009 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 11 Month 03 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=R000000620

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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