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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005310
Receipt No. R000006312
Scientific Title A relationship between pharmacokinetics (PK) and the efficacy of infliximab for patients with psoriasis
Date of disclosure of the study information 2011/04/01
Last modified on 2015/09/25

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Basic information
Public title A relationship between pharmacokinetics (PK) and the efficacy of infliximab for patients with psoriasis
Acronym Pharmacokinetics (PK) and the efficacy of infliximab in psoriasis
Scientific Title A relationship between pharmacokinetics (PK) and the efficacy of infliximab for patients with psoriasis
Scientific Title:Acronym Pharmacokinetics (PK) and the efficacy of infliximab in psoriasis
Region
Japan

Condition
Condition psoriasis
Classification by specialty
Clinical immunology Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To explore the cause of secondary lack of efficacy of infliximab therapy, by analysing PK profiles for each infusion of infliximab and anti-infliximab antibody titer in individual patients.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Serum concentration of infliximab should be examined from blood samples drawn before and 30 minutes after each infusion of 0 and 2, 6, 14, 22 weeks. Serum anti-infliximab antibody will be examined from serum sample before each infusion.
Key secondary outcomes PASI score should be recorded before each infusion of 0 and 2, 6, 14, 22 weeks.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intravenous infusion of Infliximab (5mg/kg) at 0, 2,6,14,22 weeks.
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
16 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients with psoriasis vulgaris, arthritic psoriasis, pustular psoriasis or psoriatic erythroderma whose severity is over 10 points as evaluated by PASI score or BSA or DLQI.
Key exclusion criteria Patients with severe infection, active tuberculosis, history of allergy to ingredients of infliximab or to proteins derived from mouse, demyelinating diseases and its past history and congestive heart failure. Carrier of hepatitis B virus. Patients who have a plan of immunization with vaccine.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fujimoto Wataru
Organization Kawasaki Medical School
Division name Department of Dermatology
Zip code
Address 577 Matsushima, Kurashiki, Okayama
TEL 086-462-1111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Fujimoto Wataru
Organization Kawasaki Medical School
Division name Department of Dermatology
Zip code
Address 577, Matsushima, Kurashiki, Okayama
TEL 086-462-1111
Homepage URL
Email

Sponsor
Institute Department of Dermatology, Kawasaki Medical School
Institute
Department

Funding Source
Organization Kawasaki Medical School
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 川崎医科大学附属病院(岡山県)、福山市民病院(広島県)、尾道総合病院(広島県)、福山国立医療センター(広島県)

Other administrative information
Date of disclosure of the study information
2011 Year 04 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 Completed
Date of protocol fixation
2011 Year 03 Month 04 Day
Date of IRB
Anticipated trial start date
2011 Year 05 Month 01 Day
Last follow-up date
2012 Year 07 Month 01 Day
Date of closure to data entry
2012 Year 08 Month 01 Day
Date trial data considered complete
2012 Year 09 Month 01 Day
Date analysis concluded
2012 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 03 Month 25 Day
Last modified on
2015 Year 09 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006312

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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