UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004428
Receipt number R000005293
Scientific Title Exploratory research on effectiveness and safety of Rituximab treatment for steroid intractable pemphygus, bullous pemphigoid and epidermolysis bullosa acquisita.
Date of disclosure of the study information 2010/11/01
Last modified on 2017/08/07 21:58:01

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Basic information

Public title

Exploratory research on effectiveness and safety of Rituximab treatment for steroid intractable pemphygus, bullous pemphigoid and epidermolysis bullosa acquisita.

Acronym

Rtx-BD Trial

Scientific Title

Exploratory research on effectiveness and safety of Rituximab treatment for steroid intractable pemphygus, bullous pemphigoid and epidermolysis bullosa acquisita.

Scientific Title:Acronym

Rtx-BD Trial

Region

Japan


Condition

Condition

pemphigus, bullous pemphigoid, epidermolysis bullosa acquisita

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate safety and efficacy of rituximab treatment for steroid resistant autoimmune bullous disease, pemphigus, bullous pemphigoid and epidermolysis bullosa acquisita

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

1) A rate of severe adverse events, beyond CTCAE grade 3.
2) A rate of remission

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Rituximab

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)PDAI over 10 at first and also PDAI 10 to 15 after treatment of PSL 1.0 mg/kg/day 2weeks. Patients who cannot be into complete remmision by usual treatment.
2) Over 20 years old
3) Patients who can be hospitalized 28 days.

Key exclusion criteria

Health condition
1) Pregnancy
2) Allergy for biologics
3) Severe organ disorder
4) History of other diseases which need systemic steroid treatment
5) Infections
6) Malignancy

Treatment history
1) Use of biologics
2) Severe adverse events by immunosuppressant (CTCAE over grade 3)

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masayuki Amagai

Organization

Keio University School of Medicine

Division name

Dermatology

Zip code


Address

35 Shinanomachi Shinjuku-ku, Tokyo

TEL

03-3353-1211

Email

amagai@a7.keio.jp


Public contact

Name of contact person

1st name
Middle name
Last name Julia Miyamoto

Organization

Keio University School of Medicine

Division name

Dermatology

Zip code


Address

35 Shinanomachi Shinjyuku-ku Tokyo

TEL

03-3353-1211

Homepage URL


Email

julia19780124@gmail.com


Sponsor or person

Institute

Research group of rare intractable dermatologial disorder

Institute

Department

Personal name



Funding Source

Organization

Keio University School of Medicine
Okayama University School of Medicine
Kurume University School of Medicine
Hokkaido University School of Medicine

Organization

Division

Category of Funding Organization

Other

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

慶應義塾大学病院(東京都)


Other administrative information

Date of disclosure of the study information

2010 Year 11 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

2010 Year 10 Month 18 Day

Date of IRB


Anticipated trial start date

2010 Year 11 Month 01 Day

Last follow-up date

2015 Year 11 Month 01 Day

Date of closure to data entry

2015 Year 12 Month 01 Day

Date trial data considered complete

2015 Year 12 Month 01 Day

Date analysis concluded

2016 Year 03 Month 01 Day


Other

Other related information



Management information

Registered date

2010 Year 10 Month 21 Day

Last modified on

2017 Year 08 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005293


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name