Unique ID issued by UMIN | UMIN000051601 |
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Receipt number | R000047061 |
Scientific Title | Specified drug use results survey of Stelara in patients with ulcerative colitis |
Date of disclosure of the study information | 2023/07/15 |
Last modified on | 2023/07/13 11:46:33 |
Specified drug use results survey of Stelara in patients with ulcerative colitis
Specified drug use results survey of Stelara in patients with ulcerative colitis
Specified drug use results survey of Stelara in patients with ulcerative colitis
Specified drug use results survey of Stelara in patients with ulcerative colitis
Japan |
ulcerative colitis
Gastroenterology |
Others
NO
To examine safety and efficacy of Stelara (130 mg for intravenous infusion and 45 mg for subcutaneous injection in actual clinical practice for long-term (52 weeks) in patients with ulcerative colitis
Safety,Efficacy
Safety(ADR)
Effectiveness(Partial Mayo Score)
Observational
Not applicable |
Not applicable |
Male and Female
Patients who initiate Stelara for moderate to severe active ulcerative colitis(Only patients who have failed or were intolerant to previous treatment)
Patients with a history of the use of ustekinumab(active ingredient of this product)
300
1st name | Takeshi |
Middle name | |
Last name | Koyama |
Janssen Pharmaceutical K.K.
Safety Science and Risk Management Dept.
101-0065
5-2, Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo
03-4411-5136
tkoyama4@its.jnj.com
1st name | Masayuki |
Middle name | |
Last name | Takagishi |
Janssen Pharmaceutical K.K.
Safety Science and Risk Management Dept.
101-0065
5-2, Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo
03-4411-5136
mtakagis@its.jnj.com
Janssen Pharmaceutical K.K.
Janssen Pharmaceutical K.K.
Profit organization
Janssen Pharmaceutical K.K.
5-2, Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo
03-4411-5136
mtakagis@its.jnj.com
NO
2023 | Year | 07 | Month | 15 | Day |
Unpublished
317
No longer recruiting
2020 | Year | 06 | Month | 11 | Day |
2020 | Year | 09 | Month | 01 | Day |
2020 | Year | 09 | Month | 30 | Day |
2023 | Year | 11 | Month | 30 | Day |
2023 | Year | 11 | Month | 30 | Day |
2023 | Year | 12 | Month | 31 | Day |
2024 | Year | 03 | Month | 31 | Day |
Obsevation period: Completed
2023 | Year | 07 | Month | 13 | Day |
2023 | Year | 07 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047061
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