Unique ID issued by UMIN | UMIN000032969 |
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Receipt number | R000037599 |
Scientific Title | Special drug use survey of Tremfya for Psoriasis |
Date of disclosure of the study information | 2018/06/13 |
Last modified on | 2023/08/18 14:27:10 |
Special drug use survey of Tremfya for Psoriasis
TRM1L
Special drug use survey of Tremfya for Psoriasis
TRM1L
Japan |
Psoriasis, Psoriatic arthritis, Generalized Pustular Psoriasis and Erythrodermic Psoriasis
Dermatology |
Others
NO
The special drug use survey is aimed at investigating the safety and efficacy of the long-term use (52 weeks) of Tremfya for Psoriasis, Psoriatic arthritis, Generalized Pustular Psoriasis and Erythrodermic Psoriasis in routine clinical practice. And follow up the patient for 3 years after administration of Tremfya to investigate the incidence of malignancy.
Safety,Efficacy
Variables related to safety
a. Data on adverse reactions/infection
b. Data on serious adverse events
c. Data on adverse reactions of primary survey items
d. Factors possibly affecting the safety
e. Investigation of the safety in specific patient populations (the elderly, pregnant/nursing women, patients with renal impairment, patients with hepatic function disorder)
f. Data on adverse reactions of malignancy after long term of administration
Variables related to efficacy
a. Data on adverse reactions/infection
b. Data on serious adverse events
c. Data on adverse reactions of primary survey items
d. Factors possibly affecting the safety
e. Investigation of the safety in specific patient populations (the elderly, pregnant/nursing women, patients with renal impairment, patients with hepatic function disorder)
f. Data on adverse reactions of malignancy after long term of administration
Observational
Not applicable |
Not applicable |
Male and Female
Patients who initiate Tremfya in accordance with the indication in package insert.
[Indications]
The following diseases which do not adequately respond to conventional treatments;
Psoriasis vulgaris, psoriatic arthritis, pustular psoriasis, erythrodermic psoriasis
Patients with a history of the use of ustekinumab (active ingredient of this product)
400
1st name | Takeshi |
Middle name | |
Last name | Koyama |
Janssen Pharmaceutical K.K.
Safety Science & risk management dept
101-0065
5-2, Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo
03-4411-5017
tkato1@its.jnj.com
1st name | Manami |
Middle name | |
Last name | Kamishima |
Janssen Pharmaceutical K.K.
Safety Science & risk management dept
101-0065
5-2, Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo
+81-80-8007-5440
mkamishi@its.jnj.com
Janssen Pharmaceutical K.K.
Janssen Pharmaceutical K.K.
Profit organization
Janssen Pharmaceutical K.K.
5-2, Nishikanda 3-Chome. Chiyoda-ku, Tokyo
03-4411-5018
mKamishi@its.jnj.com
NO
2018 | Year | 06 | Month | 13 | Day |
Unpublished
No longer recruiting
2018 | Year | 04 | Month | 18 | Day |
2018 | Year | 03 | Month | 23 | Day |
2018 | Year | 06 | Month | 11 | Day |
2025 | Year | 07 | Month | 12 | Day |
Special drug use survey
2018 | Year | 06 | Month | 13 | Day |
2023 | Year | 08 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037599
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