Rituximab in Chronic Inflammatory Demyelinating Polyneuropathy

Sponsor
University of Kansas Medical Center
Study ID
NCT04480450
Phase
PHASE2
Status
Withdrawn

Conditions

  • Chronic Inflammatory Demyelinating Polyneuropathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Rituximab is a highly purified, 1328-amino acid antibody with an approximate molecular mass of 145 kD. Rituximab is a mouse human chimeric monoclonal antibody against CD20. Administration leads to between 90 and 100% peripheral B cell depletion via complement dependent cytotoxicity.

Study Details

CIDP is a heterogeneous disease with variable responses to therapy. Recently, a distinctive subgroup of patients with serum autoantibodies to the paranodal proteins contactin and neurofascin have been identified. Although they present with active and serious disease, multiple clinical reports suggest that these patients can be cured with a treatment that depletes B cells and presumably eliminates pathogenic autoantibodies. However, beyond that subgroup of CIDP patients, which CIDP patients might benefit from Rituximab and B cell depletion is unknown. This Phase II study will treat 3 homogenous groups of 16 CIDP patients each with Rituximab in order to determine if there are subgroups that can be taken off current medications and put into long-term remission. The results from this study will be used to design a future larger trial. Biomarkers including paranodal antibodies, serum neurofilament light chains, anti-ganglioside antibodies will be obtained in order to learn about disease pathogenesis and possibly target therapy

Key Dates

Start date
Jul 31, 2025
Status verified
Sep 2025
Primary completion
Sep 30, 2025
Completion
Sep 30, 2025

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Active Comparator: IVIg/SCIg < 3 Years Arm
    Patients with CIDP successfully treated with IVIg/SCIg for under 12 months. Subjects will receive an intravenous infusion of 1,000mg Rituximab at Week 0 and Week 2.
  • Active Comparator: IVIg/SCIg > 3 Years Arm
    Patients with CIDP successfully treated with IVIg/SCIg for more than 12 months. Subjects will receive an intravenous infusion of 1,000mg Rituximab at Week 0 and Week 2.

Primary Outcome Measure

Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Score [ Time Frame: 48 Weeks ]

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