Unique ID issued by UMIN | UMIN000007205 |
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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 |
The efficacy and safety of adding tacrolimus to methotrexate in elderly patients with rheumatoid arthritis
The efficacy and safety of adding tacrolimus to methotrexate in elderly patients with rheumatoid arthritis
The efficacy and safety of adding tacrolimus to methotrexate in elderly patients with rheumatoid arthritis
The efficacy and safety of adding tacrolimus to methotrexate in elderly patients with rheumatoid arthritis
Japan |
Rheumatoid arthritis
Clinical immunology |
Others
NO
To examine the efficacy and safety of adding tacrolimus to methotrexate in elderly patients with rheumatoid arthritis
Safety,Efficacy
Rate of remission according to Simplified Disease Activity Index (SDAI) scoring method at week 24
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
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.
65 | years-old | <= |
Not applicable |
Male and Female
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.
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
30
1st name | |
Middle name | |
Last name | Michihiro Ogasawara |
Juntendo University
Department of Internal Medicine and Rheumatology
Hongo 3-1-3, Bunkyo-ku,Tokyo 113-8421,Japan
1st name | |
Middle name | |
Last name |
Juntendo University
Department of Internal Medicine and Rheumatology
miogasaw@juntendo.ac.jp
Juntendo University
none
Other
NO
2012 | Year | 02 | Month | 02 | Day |
Unpublished
Preinitiation
2011 | Year | 06 | Month | 24 | Day |
2012 | Year | 02 | Month | 01 | Day |
2012 | Year | 02 | Month | 02 | Day |
2012 | Year | 02 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008482
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