UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027542 |
|---|---|
| Receipt number | 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 11:18:22 |
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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
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
ayamamot@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
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031576
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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