UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026966 |
|---|---|
| Receipt number | R000030926 |
| Scientific Title | Special drug use survey of Stelara for Crohn's disease |
| Date of disclosure of the study information | 2017/05/31 |
| Last modified on | 2023/07/13 09:38:31 |
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Basic information
Public title
Special drug use survey of Stelara for Crohn's disease
Acronym
STL2L
Scientific Title
Special drug use survey of Stelara for Crohn's disease
Scientific Title:Acronym
STL2L
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The special drug use survey is aimed at investigating the safety and efficacy of the long-term use (52 weeks) of Stelara (including Intravenous Infusion 130 mg Vial and Subcutaneous Injection 45 mg Syringe, hereafter this product) for Crohn's disease in routine clinical practice. And follow up the patient for 3 years after administration of Stelara to investigate the incidence of malignancy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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.Change in CDAI
b.Change in CRP
c.Result of endoscopy
d.Physician's Global Assessment
e.Effectiveness of changing administration interval
f.Factors possibly affecting the effectiveness
g.Investigation of the effectiveness in specific patient populations (the elderly, pregnant/nursing women, patients with renal impairment, patients with hepatic function disorder)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who initiate Stelara Intravenous Infusion 130 mg Vial for moderate to severe active Crohn's disease (Only patients who have failed or were intolerant to previous treatment)
Key exclusion criteria
Patients with a history of the use of ustekinumab (active ingredient of this product)
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Toshiya |
| Middle name | |
| Last name | Kato |
Organization
Janssen Pharmaceutical K.K.
Division name
Safety risk management dept
Zip code
101-0065
Address
5-2, Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo
TEL
03-4411-5017
tkato1@its.jnj.com
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Talagishi |
Organization
Janssen Pharmaceutical K.K.
Division name
Safety risk management dept
Zip code
101-0065
Address
5-2, Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo
TEL
03-4411-5464
Homepage URL
mtakagis@its.jnj.com
Sponsor or person
Institute
Janssen Pharmaceutical K.K.
Institute
Department
Personal name
Funding Source
Organization
Janssen Pharmaceutical K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Janssen Pharmaceutical K.K.
Address
5-2, Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo
Tel
03-4411-5464
mtakagis@its.jnj.com
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
| 2017 | Year | 05 | Month | 31 | 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
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 06 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Special drug use survey
Management information
Registered date
| 2017 | Year | 04 | Month | 12 | Day |
Last modified on
| 2023 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030926
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
