Comparing Use of B-cell depletion therapy to Immunoglobulin in Chronic inflammatory demyelinating polyneuropathy (CUBIC) clinical trial.
- Conditions
- Chronic inflammatory demyelinating polyneuropathy (CIDP).Inflammatory and Immune System - Autoimmune diseasesNeurological - Other neurological disorders
- Registration Number
- ACTRN12623001336673
- Lead Sponsor
- Western Sydney Local Health District
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 35
•Adult greater than 18 years with a documented diagnosis of CIDP, according to the European Federation of Neurological Societies/ Peripheral Nerve Society (EFNS/PNS) criteria 2021
•3 doses of TGA approved COVID-19 vaccinations.
•at least 2 weeks post 3rd dose COVID-19 vaccination.
•greater than 4 months on Ig therapy and planned continuation for at least 9 months.
•No previous history of B-cell depletion therapy.
•Other immunosuppressants acceptable if dose is stable for 6+ months
•Pregnancy or planned pregnancy in the next 12 months
•Has not had 3 doses of TGA approved COVID-19 vaccinations
•Underlying primary immunodeficiency
•Current or planned treatment with plasma exchange
•Intolerance or allergy to RIXIMYO (Rituximab), or its incipient
•Contraindication for RIXIMYO (Rituximab) based on infectious disease screening.
•Diagnosis of diabetes mellitus
•Positive MAG antibodies, paranodal/nodal antibodies
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method