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Imaging of Rituximab-Zirconium-89 uptake with Positron-Emission-Tomography scans in active relapsing-remitting multiple sclerosis patients: a pilot study

Imaging of Rituximab-Zirconium-89 uptake with Positron-Emission-Tomography scans in active relapsing-remitting multiple sclerosis patients: a pilot study - PET with 89Zr-labelled rituximab in MS

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON33247
Enrollment
6
Registered
2009-12-09
Start date
2010-01-01
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MS Multiple sclerosis

Interventions

1000-mg intravenous infusions of rituximab on study days 1 and 15. Only the first administration will be partially labelled with the positron emitter Zirconium-89. PET scans will be performed on day

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Diagnosis of MS EDSS score 0.0 to 5.0 Age between 18 and 50 years >=1 MS attack(s) in the year prior to screening >=1 MS attack during treatment with interferon beta or glatiramer acetate

Exclusion criteria

Exclusion criteria: Previous treatment with mitoxantrone, natalizumab or any investigational drug for MS the year before screening Any progressive form of MS Inability to undergo MRI with gadolinium administration Pregnancy or breast feeding

Design outcomes

Primary

MeasureTime frame
89Zr-rituximab uptake in CD20 positive (actieve) MS lesions

Secondary

MeasureTime frame
Inter-patient variability in 89Zr-rituximab biodistribition.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)