UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The analysis about the efficacy of Rituximab against IgM anti-myelin-associated glycoprotein antibody demtelinating neuropathy
Title of the study (Brief title)	The analysis about the efficacy of Rituximab against IgM anti-myelin-associated glycoprotein antibody demtelinating neuropathy
Region	Japan

Condition
Condition	IgM anti-myelin-associated glycoprotein antibody demyelinating neuropathy
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Analysis about the efficacy and safety of rituximab treatment against IgM anti-myelin-assozciated glycoprotein demyelinating neuropathy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	INCAT(Inflammatory Neuropathy Course and Treatment) disability score
Key secondary outcomes	10 meter walking test serum IgM titer anti-myelin-associated glycoprotein (MAG) antibody titer

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 dose of Rituximab 375mg/m2 weekly for four consecutive 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	20 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	1. Male or female aged from 20 to 85 2. Meet the criteria of demyelinating polyneuropathy demonstrated by nerve conduction study 3. Meet the serological criteria of IgM MGUS 4. Positive anti-MAG antibody in the serum 5. Unresponsive to the past treatment: IVIg, Plasma exchange, or steroid
Key exclusion criteria	1. Had received the treatment, including IVIg, plasma exchange, or steroid within past three months 2. Has past history of hematological malignancy such as multiple myeloma, Waldenstroms macroglobulinemia, amyloidosis, and lymphoma 3. Had received some sort of immunosuppressive therapy within past six months
Target sample size	5

Research contact person
Name of lead principal investigator	Hiroo Yoshikawa
Organization	Hyogo College of Medicine Hospital
Division name	Department of Neurology
Address	1-1, Mukogawa-cho, Nishinomiya
TEL	0798-45-6598
Email	hyoshika@hyo-med.ac.jp

Public contact
Name of contact person	Hiroo Yoshikawa
Organization	Hyogo College of Medicine Hospital
Division name	Department of Neurology
Address	1-1, Mukogawa-cho, Nishinomiya
TEL	0798-45-6598
Homepage URL
Email	hyoshika@hyo-med.ac.jp

Sponsor
Institute	Hyogo College of Medicine
Institute
Department

Funding Source
Organization	self-sustaining
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

Other administrative information
Date of disclosure of the study information	2022 Year 07 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 04 Month 01 Day
Anticipated trial start date	2017 Year 05 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 04 Month 18 Day
Last modified on	2018 Year 09 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030943