Trials / Completed
CompletedNCT03864185
The Evaluation of Efficacy and Safety of Rituximab in Refractory CIDP Patients With IgG4 Autoantibodies
The Evaluation of Efficacy and Safety of Rituximab (Genetical Recombination) in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients With Immunoglobulin G4 (IgG4) Autoantibodies in the Exploratory Clinical Trial
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Nagoya University · Academic / Other
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Accepted
Summary
To evaluate the efficacy and safety of rituximab (genetical recombination) intravenously administered to CIDP patients with positive or negative IgG4 autoantibody.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Rituximab (genetical recombination) | Administer 375 mg/m2 of rituximab (genetical recombination) IV infusion once weekly for 4 doses. |
| OTHER | Placebo | Administer placebo IV infusion once weekly for 4 doses. |
Timeline
- Start date
- 2019-03-28
- Primary completion
- 2021-05-27
- Completion
- 2021-05-27
- First posted
- 2019-03-06
- Last updated
- 2021-08-20
Locations
4 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT03864185. Inclusion in this directory is not an endorsement.