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Recruitment status Terminated
Unique ID issued by UMIN UMIN000008572
Receipt No. R000010054
Scientific Title The Kitasato institute Non-inferiorty trial of Etanercept and Tacrolimus ,the combined therapy with Methotrexate in rhumatoid arthritis patients
Date of disclosure of the study information 2012/07/31
Last modified on 2019/08/07

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Basic information
Public title The Kitasato institute Non-inferiorty trial of Etanercept and Tacrolimus ,the combined therapy with Methotrexate in rhumatoid arthritis patients
Acronym K-NET study: The Kitasato institute Non-inferiorty trial of Etanercept and Tacrolimus ,the combined therapy with Methotrexate in rhumatoid arthritis patients
Scientific Title The Kitasato institute Non-inferiorty trial of Etanercept and Tacrolimus ,the combined therapy with Methotrexate in rhumatoid arthritis patients
Scientific Title:Acronym K-NET study: The Kitasato institute Non-inferiorty trial of Etanercept and Tacrolimus ,the combined therapy with Methotrexate in rhumatoid arthritis patients
Region
Japan

Condition
Condition Rheumatoid arthritis (RA) with inadequate response to methotrexate (MTX)
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to compare the efficacy and safety between tacrolimus and etanercept in the treatment of RA in Japan.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The American College of Rheumatology 20% response (ACR20) at week 52.
Key secondary outcomes Secondary endpoint variables include Disease activity score in 28 joints (DAS28), simplified disease activity index (SDAI), clinical disease activity index (CDAI), modified Health Assessment Questionaire (m-HAQ), protocol persistence rate, and adverse event.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Tacrolimus group patients receive daily the optimal dosage of tacrolimus within the range between 1.5-3.0 mg/day for 52 weeks.
Interventions/Control_2 Etanercept group patient receive weekly subcutaneous injection of etanercept 50mg for 52 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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria 1) Patient is diagnosed with RA according to the American College of Rheumatology / European League Against Rheumatism (ACR/EULAR) classification criteria 2010.
2) outpatients who don't participate in other clinical trial.
3) Patients with inadequate response to MTX more than 8mg/weeks dosage for more than 12weeks.
4) Subject has signed the informed consent form.
Key exclusion criteria 1) Patient who is contraindicated for tacrolimus and etanercept.
2) RA patient treated with tacrolimus and/or biologics before the study.
3) PSL dosage is more than 7.5mg/day and increased within 4weeks before the study.
4) patient who has been judged inappropriate to the study by responsible doctor.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shunsei Hirohata
Organization Kitasato university school of medicine
Division name Rheumatology and infectious disease
Zip code
Address 1-15-1 kitasato, Minami-ku, Sagamihara, Japan
TEL 042-778-8745
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuhiko Wada
Organization Kitasato university school of medicine
Division name Rheumatology and infectious disease
Zip code
Address 1-15-1 kitasato, Minami-ku, Sagamihara, Japan
TEL 042-778-8745
Homepage URL
Email k-net@med.kitasato-u.ac.jp

Sponsor
Institute Department of Rheumatology and infectious disease, Kitasato university school of medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Department of Rheumatology and infectious disease, Kitasato university school of medicin
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor 1)Kitasato institute medical center hospital
2)Kitasato institute hospital
3)Ishikawa internal medicine clinic
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 北里研究所メディカルセンター病院(埼玉県)
北里研究所病院(東京都)
いしかわ内科クリニック(東京都)

Other administrative information
Date of disclosure of the study information
2012 Year 07 Month 31 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 Terminated
Date of protocol fixation
2012 Year 07 Month 09 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 31 Day
Last follow-up date
2015 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 07 Month 30 Day
Last modified on
2019 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010054


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