The efficacy and safety of 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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000019285

Enrollment

Registered

2015-10-09

Start date

2008-02-12

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuropathy associated with IgM monoclonal gammopathy with anti-myelin-associated glycoprotein antibody

Interventions

Intravenous dose of 375mg/mm2 weekly for four consecutive weeks

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Modified Rankin scale (mRS)	—

Secondary

Measure	Time frame
Medical Research Council (MRC) sum score Sensory sum score (SSS) Tolerability Adverse effects	—

Countries

Japan

Contacts

Public ContactYuichi Kawagashira

Nagoya University Graduate School of Medicine Department of Neurology

kashira@med.nagoya-u.ac.jp052-744-2391

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026