Influence of B cell depletion therapy (rituximab) on (risk factors of) comorbidity in rheumatoid arthritis

Recruiting

• Conditions: rheumatoid arthritis; 10003816; 10082206; 10023213

• Registration Number: NL-OMON31299
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

According to the thesis of the Dutch association of rheumatology (NVR): treatment with rituximab of rheumatoid arthritis patients:
- rheumatoid arthritis diagnosed according to the ACR criteria 1987
- active rheumatoid arthritis
- previous failure of TNF alpha blocking

Exclusion Criteria

- malignity
- active tuberculosis or other active infection
- pregnancy and lactation
- severe heart failure (NYHA IV) or other cardiac disease
- hypersensitivity to one of the active substances of rituximab or murine proteins

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>Primary study variables will be a change in lipids (total cholesterol, HDL, LDL<br /><br>and TG) and lipoproteins (Lp-a, Apo-A1, Apo-B), bonemineral densitiy (DEXA) and<br /><br>bonemarkers (osteocalcine, OPG, *-CTx and RANKL) and antibodyformation.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary study variables will be a change in disease activity (DAS 28),<br /><br>functional capacity (HAQ-score), radiologic progression (Sharp van der Heyde<br /><br>score) and B cell count.</p><br>