Rituximab-induced Pulmonary Function Changes

Rituximab-induced Pulmonary Function Changes - an Observational Study in Patients With Rheumatoid Arthritis and Inflammatory Myositis

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01632124

Enrollment

Registered

2012-06-29

Start date

2012-01-31

Completion date

2013-12-31

Last updated

2012-06-29

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

Conditions

Inflammatory Myositis, Rheumatoid Arthritis

Brief summary

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

Detailed 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.

Interventions

OTHERLung function measurement

Spirometry and measurement of diffusing capacity for carbon monoxide

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Countries

Switzerland

Contacts

Primary ContactDaniel Franzen, MD

daniel.franzen@usz.ch

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026