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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026966
Receipt No. 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 2017/10/12

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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
Middle name
Last name Toshiya Kato
Organization Janssen Pharmaceutical K.K.
Division name Safety risk management dept
Zip code
Address 5-2, Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo
TEL 03-4411-5017
Email tkato1@its.jnj.com

Public contact
Name of contact person
1st name
Middle name
Last name Yuko Kojima
Organization Janssen Pharmaceutical K.K.
Division name Safety risk management dept
Zip code
Address 5-2, Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo
TEL 03-4411-5437
Homepage URL
Email ykojima4@its.jnj.com

Sponsor
Institute Janssen Pharmaceutical K.K.
Institute
Department

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
Address
Tel
Email

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 Enrolling by invitation
Date of protocol fixation
2017 Year 05 Month 06 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 24 Day
Last follow-up date
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
2017 Year 10 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030926

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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