Unique ID issued by UMIN | UMIN000031019 |
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Receipt number | R000035407 |
Scientific Title | An uncontrolled intervention trial on the effect of denosumab on QOL in patients with rheumatoid arthritis |
Date of disclosure of the study information | 2018/03/01 |
Last modified on | 2019/05/15 10:34:05 |
An uncontrolled intervention trial on the effect of denosumab on QOL in patients with rheumatoid arthritis
An uncontrolled intervention trial on the effect of denosumab on QOL in patients with rheumatoid arthritis
An uncontrolled intervention trial on the effect of denosumab on QOL in patients with rheumatoid arthritis
An uncontrolled intervention trial on the effect of denosumab on QOL in patients with rheumatoid arthritis
Japan |
rheumatoid arthritis
Orthopedics |
Others
NO
Evaluation of EQ-5D change at 42 months after administration from baseline.
Safety,Efficacy
Not applicable
The value of EQ-5D at 42 months after administration
inflammatory cytokine, Bone mineral density, bone turnover marker, blood test data, disease activity, image evaluation, adverse event, the retention rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
PRALIA 60mg subcutaneous injection every 6 months for 36 months.
20 | years-old | <= |
Not applicable |
Male and Female
(1)Patients who are 20 years old or more at the time of consent acquisition.
(2)Patients with RA diagnosed according to 1987 ACR criteria or 2010 ACR / EULAR criteria for RA.
(3)Patients from which written informed consent to participate in this trial was obtained.
(1)Patients with osteoporosis
(2)Serum Ca value < 8.0 mg / dL
(3)Patients who are treated with RANMARK.
(4)Moderate or higher renal failure
(5)gingivitis or receiving dental procedures.
(6)Dementia or mental disorder.
(7)drug hypersensitivity
(8)Pregnant women and patients who may be pregnant or breast-feeding patients
(9)Patients who participated in other clinical trials within 4 months
(10)Patients judged inappropriate for participation in this trial by the person in charge.
300
1st name | Shinya |
Middle name | |
Last name | Hayashi |
Kobe University Hospital
Department of Orthopaedic Surgery
650-0017
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan
078-382-5985
s11793290@yahoo.co.jp
1st name | Shinya |
Middle name | |
Last name | Hayashi |
Kobe University Hospital
Department of Orthopaedic Surgery
650-0017
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan
078-382-5985
s11793290@yahoo.co.jp
Kobe University
Kobe University
Other
Kobe University hospital clinical and translational research center
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan
078-382-6669
chiken@med.kobe-u.ac.jp
NO
2018 | Year | 03 | Month | 01 | Day |
Unpublished
Enrolling by invitation
2018 | Year | 02 | Month | 20 | Day |
2018 | Year | 03 | Month | 26 | Day |
2018 | Year | 03 | Month | 26 | Day |
2024 | Year | 09 | Month | 30 | Day |
2018 | Year | 01 | Month | 26 | Day |
2019 | Year | 05 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035407
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