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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON31299

Enrollment

Registered

2008-02-15

Start date

2008-03-03

Completion date

Unknown

Last updated

2024-06-18

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

Conditions

rheumatoid arthritis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Primary study variables will be a change in lipids (total cholesterol, HDL, LDL and TG) and lipoproteins (Lp-a, Apo-A1, Apo-B), bonemineral densitiy (DEXA) and bonemarkers (osteocalcine, OPG, *-CTx and RANKL) and antibodyformation.	—

Secondary

Measure	Time frame
Secundary study variables will be a change in disease activity (DAS 28), functional capacity (HAQ-score), radiologic progression (Sharp van der Heyde score) and B cell count.	—

Countries

Netherlands

Outcome results