Rituximab-induced Pulmonary Function Changes

University of Zurich (UZH)

Status: Unknown

Conditions: Inflammatory Myositis; Rheumatoid Arthritis

Treatments: Other: Lung function measurement

Study type: Observational

Funder types: Other

Identifiers

NCT01632124

RTX

Details and patient eligibility

About

Measuring lung function (FVC, FEV1, DLCO) before, during and after treatment with rituximab in patients with rheumatoid arthritis or inflammatory myositis.

Full description

The objective of this study is to investigate whether rituximab (RTX), a drug commonly prescribed in patients with rheumatoid arthritis (RA) or inflammatory myositis, is associated with subclinical interstitial lung disease (ILD). Surrogate markers for interstitial lung diseases are a decrease of the forced vital capacity (FVC) and/or the diffusing capacity of the lung for carbon monoxide (DLCO). However, the measurement of these lung function parameters is indicated as regular follow-up examinations during the treatment with RTX according to the principles of "good clinical practice". We will perform pulmonary function testing (spirometry) including measurement of the DLCO in patients with RA, who are going to be treated with RTX. A baseline lung function measurement will be performed immediately before RTX therapy is started. Follow-up measurements will be performed at 2 weeks, 4 weeks, 8 weeks and 6 months after initiation of RTX therapy. A reduction in forced vital capacity (FVC) of >10% or a fall of >15% in DLCO will be defined as indicative for ILD.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria: - Patients with established diagnosis of RA or inflammatory myositis, in whom a de novo RTX treatment is indicated

• Age >18 y
• Informed consent of patient

Exclusion criteria: - Acute infection

• Pre-existing interstitial pulmonary disease
• Patients with impaired forced vital capacity (FVC) on spirometry (<80% predicted) or with impaired DLCO (<75% predicted).
• Pregnancy