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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	JPRN
Last refreshed on:	20 November 2023
Main ID:	JPRN-UMIN000007702
Date of registration:	24/04/2012
Prospective Registration:	Yes
Primary sponsor:	Department of Dermatology, The University of Tokyo
Public title:	Clinical trial of rituximab in interstitial lung disease secondary to systemic sclerosis
Scientific title:	Clinical trial of rituximab in interstitial lung disease secondary to systemic sclerosis - Clinical trial of rituximab in interstitial lung disease secondary to systemic sclerosis
Date of first enrolment:	2012/04/26
Target sample size:	20
Recruitment status:	Complete: follow-up complete
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009084
Study type:	Interventional
Study design:	Single arm Non-randomized
Phase:	Not selected

Countries of recruitment
Japan

Contacts

Name:	Ayumi Yoshizaki
Address:	7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan 113-8655 Japan
Telephone:	03-5800-8661
Email:	yoshizakiay-der@h.u-tokyo.ac.jp
Affiliation:	The University of Tokyo Department of Dermatology

Name:	Ayumi Yoshizaki
Address:	7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan Japan
Telephone:	03-5800-8661
Email:	yoshizakiay-der@h.u-tokyo.ac.jp
Affiliation:	The University of Tokyo Department of Dermatology

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: 1)during treatment with equal drug 2)previous history of anaphylactic reactions to this drug 3)significant infection 4)significant liver damage 5)significant renal damage 6)less than or equal to 60% of %VC or 40% of %DLco 7)previous history of significant infection 8)pregnancy 9)breast-feeding 10)participating in other clinical trial within three months before the beginning of this trial 11)judged inappropriate for this study by the physicians

Age minimum: 20years-old
Age maximum: 80years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Interstitial lung disease secondary to systemic sclerosis

Intervention(s)

Rituximab(+) 30weeks 375mg/m2 once a week 4 times

Primary Outcome(s)

Lung function test

Secondary Outcome(s)

Assessment of interstitial lung disease progression on CT Serum levels of KL-6 and SP-D Assessment of Safety

Secondary ID(s)

Source(s) of Monetary Support

The University of Tokyo

Secondary Sponsor(s)

Ethics review

Status: YES
Approval date: 26/04/2012
Contact:

crctky-office@umin.ac.jp

Clinical research center, The University of Tokyo Hospital

03-5800-8743

crctky-office@umin.ac.jp

Results

Results available:	Yes
Date Posted:
Date Completed:	21/10/2021
URL:

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