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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027542
Receipt No. R000031576
Scientific Title Special drug use results surveillance for the use of SIMPONI in ulcerative colitis
Date of disclosure of the study information 2017/06/01
Last modified on 2019/03/06

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Basic information
Public title Special drug use results surveillance for the use of SIMPONI in ulcerative colitis
Acronym SMP4L
Scientific Title Special drug use results surveillance for the use of SIMPONI in ulcerative colitis
Scientific Title:Acronym SMP4L
Region
Japan

Condition
Condition ulcerative colitis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate safety and effectiveness of SIMPONI Subcutaneous Injection 50 mg Syringe (hereinafter, "SIMPONI") in long-term use for ulcerative colitis (hereinafter, "this Survey"). In addition, follow up the patient for 3 years after administration of SIMPONI to investigate the incidence of malignancy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety analysis
a. Onset status of adverse drug reactions including infectious events
b. Onset status of serious adverse events
c. Influencing factors
d. Onset status of safety concerns and special interests
e. Investigations on special populations (pediatric, elderly, pregnant/delivering/nursing women, patients with renal dysfunction, patients with hepatic dysfunction)

Efficacy analysis
a. Rate of responders
b. Change in partial Mayo score
c. Rate of clinical response
d. Influencing factors
e. Investigations on special populations (pediatric, elderly, pregnant/delivering/nursing women, patients with renal dysfunction, patients with hepatic dysfunction)
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 received SIMPONI for the first time for its indication "inducing clinical response and maintenance therapy in patients with moderate to severe active ulcerative colitis (only patients who have had an adequate response to conventional therapy)".
Key exclusion criteria Patients with a history of use of Golimumab (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 03-4411-5478
Email tkato1@its.jnj.com

Public contact
Name of contact person
1st name
Middle name
Last name Akiko Yamamoto
Organization Janssen Pharmaceutical K.K.
Division name Safety Risk Management Dept.
Zip code
Address 5-2, Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo
TEL 03-4411-5173
Homepage URL
Email ayamamot@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 06 Month 01 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 No longer recruiting
Date of protocol fixation
2017 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 15 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 results surveillance

Management information
Registered date
2017 Year 05 Month 30 Day
Last modified on
2019 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031576

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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