None listed
Conditions
Brief summary
The aim of the CUBIC Clinical Trial is to find better treatment options for Chronic inflammatory demyelinating polyneuropathy (CIDP). CIDP is a rare neurological disorder that results in slowly progressive weakness and loss of feeling in the legs and arms. CIDP is commonly treated with immunoglobulin, which must be given every 3-4 weeks and patients may need to continue treatment for the rest of their lives. The purpose of this study is to see if we can use other medication to manage the symptoms of CIDP and reduce the amount of immunoglobulin needed. This could mean that CIDP patients could be treated with a lower dose of immunoglobulin or could potentially no longer need immunoglobulin. The results of this study will help to inform the medical community of the best treatment to give to people who have CIDP in the future.
Interventions
It is an inclusion criterion for this trial that participants must have already been receiving intravenous immunoglobulin treatment for chronic inflammatory demyelinating polyneuropathy (CIDP) for at least 4 months prior to enrolment. Eligible participants will be administered (unblinded) two consecutive doses of RIXIMYO (Rituximab) (1000mg), delivered by intravenous infusion, two weeks apart in Phase 1 of the CUBIC trial. Twelve (12) weeks after dose 1 of RIXIMYO (Rituximab), participants’ Intr
It is an inclusion criterion for this trial that participants must have already been receiving intravenous immunoglobulin treatment for chronic inflammatory demyelinating polyneuropathy (CIDP) for at least 4 months prior to enrolment. Eligible participants will be administered (unblinded) two consecutive doses of RIXIMYO (Rituximab) (1000mg), delivered by intravenous infusion, two weeks apart in Phase 1 of the CUBIC trial. Twelve (12) weeks after dose 1 of RIXIMYO (Rituximab), participants’ Intravenous immunoglobulin dose (participant dependent) will be reduced by 50% and they will have blood samples collected every 3-4 weeks to monitor for B-cell reconstitution. (B-cell reconstitution is participant dependent, however, is estimated between 6-12months after first two doses of RIXIMYO (Rituximab)). All participants - from the point of B-cell reconstitution - will enter Phase 2 of the CUBIC trial. Participants will have the option of continuing Phase 2 in one of two pathways: Phase 2A: Administration (unblinded) of two more consecutive doses of RIXIMYO (Rituximab) (1000mg), delivered by intravenous infusion, two weeks apart. Twelve (12) weeks after the 1st round of RIXIMYO (Rituximab), the participants' intravenous immunoglobulin dose will cease and they will have blood samples collected every 3-4 weeks to monitor for B-cell reconstitution. (B-cell reconstitution is participant dependent, however, is estimated between 6-12months after the two doses of RIXIMYO (Rituximab)). Phase 2B: Continue to receive immunoglobulin infusions at 50% of pre-trial dose and to be clinically monitored for 12 months. The trial intervention will be delivered in clinic, by the participant's treating neurologist. Adherence to the intervention will be monitored by use of a REDCap instrument, filled out by the treating neurologist and/or study nurse, to document that RIXIMYO (RItuximab) doses were delivered according to protocol.
Sponsors
Western Sydney Local Health District
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• 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
Exclusion criteria
• 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
Outcome results
None listed