Unique ID issued by UMIN | UMIN000019285 |
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Receipt number | 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 19:07:11 |
The efficacy and safety of rituximab in neuropathy associated with IgM monoclonal gammopathy with anti-myelin-associated glycoprotein antibody
Rituximab in neuropathy associated with IgM monoclonal gammopathy with anti-myelin-associated glycoprotein antibody
The efficacy and safety of rituximab in neuropathy associated with IgM monoclonal gammopathy with anti-myelin-associated glycoprotein antibody
Rituximab in neuropathy associated with IgM monoclonal gammopathy with anti-myelin-associated glycoprotein antibody
Japan |
Neuropathy associated with IgM monoclonal gammopathy with anti-myelin-associated glycoprotein antibody
Neurology |
Others
NO
To assess the efficacy and safety of rituximab in the patients with neuropathy associated with IgM monoclonal gammopathy with anti-myelin-associated glycoprotein antibody
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Modified Rankin scale (mRS)
Medical Research Council (MRC) sum score
Sensory sum score (SSS)
Tolerability
Adverse effects
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Intravenous dose of 375mg/mm2 weekly for four consecutive weeks
30 | years-old | <= |
80 | years-old | > |
Male and Female
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
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
7
1st name | |
Middle name | |
Last name | Gen Sobue |
Nagoya University Graduate School of Medicine
Department of Neurology
65, Tsurumai-cho, Showa-ku, Nagoya
052-744-2391
sobueg@med.nagoya-u.ac.jp
1st name | |
Middle name | |
Last name | Yuichi Kawagashira |
Nagoya University Graduate School of Medicine
Department of Neurology
65, Tsurumai-cho, Showa-ku, Nagoya
052-744-2391
kashira@med.nagoya-u.ac.jp
Nagoya University Graduate School of Medicine
Grants-in-Aid for Scientific Research
KAKENHI (grant number 26461292)
Japan
NO
名古屋大学医学部附属病院 (愛知県)
Nagoya University Graduate School of Medicine (Aichi prefecture)
2015 | Year | 10 | Month | 09 | Day |
http://www.ncbi.nlm.nih.gov/pubmed/25467141
Published
http://www.ncbi.nlm.nih.gov/pubmed/25467141
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.
Completed
2008 | Year | 01 | Month | 30 | Day |
2008 | Year | 02 | Month | 12 | Day |
2012 | Year | 09 | Month | 07 | Day |
2012 | Year | 09 | Month | 07 | Day |
2012 | Year | 09 | Month | 07 | Day |
2013 | Year | 08 | Month | 28 | Day |
2015 | Year | 10 | Month | 08 | Day |
2015 | Year | 10 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022299
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