UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005310 |
|---|---|
| Receipt number | 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 12:43:08 |
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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
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
Sponsor or person
Institute
Department of Dermatology, Kawasaki Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006312
