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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000007205
Receipt No. R000008482
Scientific Title The efficacy and safety of adding tacrolimus to methotrexate in elderly patients with rheumatoid arthritis
Date of disclosure of the study information 2012/02/02
Last modified on 2012/02/02

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Basic information
Public title The efficacy and safety of adding tacrolimus to methotrexate in elderly patients with rheumatoid arthritis
Acronym The efficacy and safety of adding tacrolimus to methotrexate in elderly patients with rheumatoid arthritis
Scientific Title The efficacy and safety of adding tacrolimus to methotrexate in elderly patients with rheumatoid arthritis
Scientific Title:Acronym The efficacy and safety of adding tacrolimus to methotrexate in elderly patients with rheumatoid arthritis
Region
Japan

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

Objectives
Narrative objectives1 To examine the efficacy and safety of adding tacrolimus to methotrexate in elderly patients with rheumatoid arthritis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rate of remission according to Simplified Disease Activity Index (SDAI) scoring method at week 24
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 1) Tacrolimus
Oral administration of tacrolimus is started usually at a dose of 1.5 mg/day immediately after informed consent is obtained.
The dose can be increased or decreased within the limits of 3 mg/day with taking into account symptoms, adverse reactions and so on.
However, the administration of tacrolimus can be started at a dose of 0.5 or 1.0 mg/day in order to reduce adverse effects.
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients are eligible if they meet all the following criteria.
1) Patients who are diagnosed as rheumatoid arthritis, not less than 65 years old, and provide written informed consent.
2) Patients whose SDAI, an index of a disease activity, is more than 3.3, although MTX was administered for at least three months at the maximum tolerated dose.
Key exclusion criteria Patients are excluded if they meet any one of the following criteria.
1)Patients whose disease activities are not expected to be fully controlled by combination therapy of tacrolimus and MTX, because their disease activities are very high.
2)Patients having suffered from hypersensitivity against the ingredients of tacrolimus capsules.
3)Patients being administered cyclosporine or bosentan.
4)Patients being administered potassium sparing diuretics.
5)Patients who are pregnant or suspected to be pregnant; or patients who are breast-feeding; or patients who are expected to be pregnant during the study period.
6)Patients who are administered Tacrolimus within three months before informed consent.
7)Patients having an active infectious disease.
8)Patient who have active parenchymatous pneumonia or active interstitial pneumonia (including idiopathic pneumonia)
9)Patients who have abnormal glucose tolerance (a fasting blood sugar level is 110 or more mg/dL, and the blood sugar level after a meal is 200 or more mg/dL)
10Patients who have renal disfunction
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michihiro Ogasawara
Organization Juntendo University
Division name Department of Internal Medicine and Rheumatology
Zip code
Address Hongo 3-1-3, Bunkyo-ku,Tokyo 113-8421,Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Juntendo University
Division name Department of Internal Medicine and Rheumatology
Zip code
Address
TEL
Homepage URL
Email miogasaw@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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
2012 Year 02 Month 02 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 Preinitiation
Date of protocol fixation
2011 Year 06 Month 24 Day
Date of IRB
Anticipated trial start date
2012 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 02 Month 02 Day
Last modified on
2012 Year 02 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008482

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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