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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032969
Receipt No. R000037599
Scientific Title Special drug use survey of Tremfya for Psoriasis
Date of disclosure of the study information 2018/06/13
Last modified on 2018/06/13

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Basic information
Public title Special drug use survey of Tremfya for Psoriasis
Acronym TRM1L
Scientific Title Special drug use survey of Tremfya for Psoriasis
Scientific Title:Acronym TRM1L
Region
Japan

Condition
Condition Psoriasis, Psoriatic arthritis, Generalized Pustular Psoriasis and Erythrodermic Psoriasis
Classification by specialty
Dermatology
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 Tremfya for Psoriasis, Psoriatic arthritis, Generalized Pustular Psoriasis and Erythrodermic Psoriasis in routine clinical practice. And follow up the patient for 3 years after administration of Tremfya to investigate the incidence of malignancy.
Basic objectives2 Safety,Efficacy
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. 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
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 Tremfya in accordance with the indication in package insert.

[Indications]
The following diseases which do not adequately respond to conventional treatments;
Psoriasis vulgaris, psoriatic arthritis, pustular psoriasis, erythrodermic psoriasis
Key exclusion criteria Patients with a history of the use of ustekinumab (active ingredient of this product)
Target sample size 400

Research contact person
Last 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
1st name of contact person
1st name
Middle name
Last name Manami Kamishima
Organization Janssen Pharmaceutical K.K.
Division name Safety risk management dept
Zip code
Address 5-2, Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo
TEL +81-80-8007-5440
Homepage URL
Email mkamishi@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
2018 Year 06 Month 13 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 Open public recruiting
Date of protocol fixation
2018 Year 04 Month 18 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 11 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
2018 Year 06 Month 13 Day
Last modified on
2018 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037599

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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