Prevention of RA by B cell directed therapy.

• Conditions: pre-clinical RA

• Registration Number: NL-OMON28176
• Lead Sponsor: Academic Medical Center/University of Amsterdam, Amsterdam

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 90

Inclusion Criteria

Patients with pre-clinical RA, defined by the presence of arthralgia and at least one of the following features:

1. IgM-rheumatoid factor (IgM-RF) of > 12.5 IU/ml;

Exclusion Criteria

1. Clinically evident arthritis;

2. History of arthritis;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study if B cell depleting therapy delays/prevents the development of arthritis in patients with preclinical RA.<br>The primary outcome measure is defined by the time to occurence of clinical arthritis.

Secondary Outcome Measures

Name	Time	Method
1. To determine if prevention of RA by B cell depleting therapy is cost-effective and safe;<br /><br>2. To study the effect of B cell depleting therapy in patients with pre-clinical RA;<br /><br>3. To explore the pharmacodynamics of B cell therapy in this patient.