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

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 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


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

Value
https://center6.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