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PET-CT of biodistribution of rituximab in relation to therapeutic outcome and histological response of lymphoid tissue in rheumatoid arthritis patients

PET-CT of biodistribution of rituximab in relation to therapeutic outcome and histological response of lymphoid tissue in rheumatoid arthritis patients - Rituximab PET-CT of rheumatoid arthritis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON38399
Enrollment
15
Registered
2010-07-05
Start date
2010-10-08
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

rheumatic disease of the joints Rheumatoid arthritis

Interventions

None listed

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1.Men and women, * 18 years of age 2.Diagnosis of rheumatoid arthritis according to the ACR criteria (Arnett et al 1988) 3.Treatment with disease modifying anti-rheumatic drugs (DMARDS) and in addition, corticosteroids up to 10 mg daily and non-steroidal anti-inflammatory drugs (NSAIDs) is permitted, provided that there is a stable dose for at least 2 weeks. Patients should have been treated previously with at least one anti-tumour necrosis factor (anti-TNF) medication with inadequate response or intolerance. Anti-TNF should be discontinued at least 4 weeks before initiation of rituximab treatment. 4.Patients must be able to adhere to the study appointments and other protocol requirements. 5. Patients must be capable of giving informed consent and the consent must have been obtained prior to the study related procedures.

Exclusion criteria

Exclusion criteria: 1.Treatment with any investigational drug within the previous 3 months. 2.Pregnancy or breast-feeding. 3.Previous exposure to radioactivity (nuclear imaging) in the year preceding inclusion in this study.

Design outcomes

Primary

MeasureTime frame
Visualized tissue biodistribution patterns of RA patients by [89Zr]rituximab PET-CT at initiation of treatment.

Secondary

MeasureTime frame
1. [89Zr]rituximab PET-CT images of RA responders and non-responders to rituximab treatment. 2. Analysed lymphoid tissue response to rituximab treatment in relation to clinical outcome and imaging data.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)