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

Completed

• Conditions: rheumatic disease of the joints; Rheumatoid arthritis; 10003816

• Registration Number: NL-OMON38399
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

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

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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Visualized tissue biodistribution patterns of RA patients by [89Zr]rituximab<br /><br>PET-CT at initiation of treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. [89Zr]rituximab PET-CT images of RA responders and non-responders to<br /><br>rituximab treatment.<br /><br>2. Analysed lymphoid tissue response to rituximab treatment in relation to<br /><br>clinical outcome and imaging data. </p><br>