Rituximab-induced Pulmonary Function Changes

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01632124
• Other study ID #: RTX
• Status: Recruiting
• Phase: N/A
• First received: June 28, 2012
• Last updated: June 28, 2012
• Start date: January 2012
• Est. completion date: December 2013

Study information

• Verified date: June 2012
• Source: University of Zurich
• Contact: Daniel Franzen, MD
• Email: daniel.franzen[@]usz.ch
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Inflammatory Myositis
• Myositis
• Rheumatoid Arthritis

Intervention

Other:
• Lung function measurement
Spirometry and measurement of diffusing capacity for carbon monoxide

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Division of Internal Medicine	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland,