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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019285
Receipt No. R000022299
Scientific Title The efficacy and safety of rituximab in neuropathy associated with IgM monoclonal gammopathy with anti-myelin-associated glycoprotein antibody
Date of disclosure of the study information 2015/10/09
Last modified on 2015/10/08

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Basic information
Public title The efficacy and safety of rituximab in neuropathy associated with IgM monoclonal gammopathy with anti-myelin-associated glycoprotein antibody
Acronym Rituximab in neuropathy associated with IgM monoclonal gammopathy with anti-myelin-associated glycoprotein antibody
Scientific Title The efficacy and safety of rituximab in neuropathy associated with IgM monoclonal gammopathy with anti-myelin-associated glycoprotein antibody
Scientific Title:Acronym Rituximab in neuropathy associated with IgM monoclonal gammopathy with anti-myelin-associated glycoprotein antibody
Region
Japan

Condition
Condition Neuropathy associated with IgM monoclonal gammopathy with anti-myelin-associated glycoprotein antibody
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy and safety of rituximab in the patients with neuropathy associated with IgM monoclonal gammopathy with anti-myelin-associated glycoprotein antibody
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Modified Rankin scale (mRS)
Key secondary outcomes Medical Research Council (MRC) sum score
Sensory sum score (SSS)
Tolerability
Adverse effects

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 375mg/mm2 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
30 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1. Male or female aged from 30 to 80
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
Target sample size 7

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Gen Sobue
Organization Nagoya University Graduate School of Medicine
Division name Department of Neurology
Zip code
Address 65, Tsurumai-cho, Showa-ku, Nagoya
TEL 052-744-2391
Email sobueg@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuichi Kawagashira
Organization Nagoya University Graduate School of Medicine
Division name Department of Neurology
Zip code
Address 65, Tsurumai-cho, Showa-ku, Nagoya
TEL 052-744-2391
Homepage URL
Email kashira@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Grants-in-Aid for Scientific Research
KAKENHI (grant number 26461292)
Organization
Division
Category of Funding Organization
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 名古屋大学医学部附属病院 (愛知県)
Nagoya University Graduate School of Medicine (Aichi prefecture)

Other administrative information
Date of disclosure of the study information
2015 Year 10 Month 09 Day

Related information
URL releasing protocol http://www.ncbi.nlm.nih.gov/pubmed/25467141
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/25467141
Number of participants that the trial has enrolled
Results
4 of 7 patients improved by more than 5% either clinical scale at 12 months after rituximab treatment. With respect to the relationship between response to rituximab treatment and other clinical, electrophysiolosical and pathological findings, shorter interval from symptom onset to the initiation of rituximab treatment and preservation of nerve fiber density were significantly related.
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
2008 Year 01 Month 30 Day
Date of IRB
Anticipated trial start date
2008 Year 02 Month 12 Day
Last follow-up date
2012 Year 09 Month 07 Day
Date of closure to data entry
2012 Year 09 Month 07 Day
Date trial data considered complete
2012 Year 09 Month 07 Day
Date analysis concluded
2013 Year 08 Month 28 Day

Other
Other related information

Management information
Registered date
2015 Year 10 Month 08 Day
Last modified on
2015 Year 10 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022299

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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