The Evaluation of Efficacy and Safety of Rituximab in Refractory CIDP Patients With IgG4 Autoantibodies

Sponsor
Nagoya University
Study ID
NCT03864185
Phase
PHASE2
Status
Completed

Conditions

  • Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Rituximab (genetical recombination) — BIOLOGICAL
    Administer 375 mg/m2 of rituximab (genetical recombination) IV infusion once weekly for 4 doses.
  • Placebo — OTHER
    Administer placebo IV infusion once weekly for 4 doses.

Study Details

To evaluate the efficacy and safety of rituximab (genetical recombination) intravenously administered to CIDP patients with positive or negative IgG4 autoantibody.

Key Dates

Start date
Mar 28, 2019
Status verified
Aug 2021
Primary completion
May 27, 2021
Completion
May 27, 2021

Study Design

Enrollment
25 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Rituximab group (IgG4 autoantibody positive)
  • Placebo Comparator: Placebo group (IgG4 autoantibody positive)
  • Active Comparator: Rituximab group (IgG4 autoantibody negative)

Primary Outcome Measure

Rate of patients with improvement in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability scale [ Time Frame: Up to 52 weeks ]

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