UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027050 |
|---|---|
| Receipt number | R000030943 |
| Scientific Title | The analysis about the efficacy of Rituximab against IgM anti-myelin-associated glycoprotein antibody demtelinating neuropathy |
| Date of disclosure of the study information | 2022/07/01 |
| Last modified on | 2018/09/18 09:25:25 |
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Basic information
Public title
The analysis about the efficacy of Rituximab against IgM anti-myelin-associated glycoprotein antibody demtelinating neuropathy
Acronym
The analysis about the efficacy of Rituximab against IgM anti-myelin-associated glycoprotein antibody demtelinating neuropathy
Scientific Title
The analysis about the efficacy of Rituximab against IgM anti-myelin-associated glycoprotein antibody demtelinating neuropathy
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Hiroo Yoshikawa |
Organization
Hyogo College of Medicine Hospital
Division name
Department of Neurology
Zip code
Address
1-1, Mukogawa-cho, Nishinomiya
TEL
0798-45-6598
hyoshika@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroo Yoshikawa |
Organization
Hyogo College of Medicine Hospital
Division name
Department of Neurology
Zip code
Address
1-1, Mukogawa-cho, Nishinomiya
TEL
0798-45-6598
Homepage URL
hyoshika@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Terminated
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030943
