UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007205
Receipt number 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 11:51:35

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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 or person

Institute

Juntendo University

Institute

Department

Personal name



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

Value
https://center6.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