Rituximab-induced Pulmonary Function Changes

• Conditions: Rheumatoid Arthritis; Inflammatory Myositis

• Registration Number: NCT01632124
• Lead Sponsor: University of Zurich

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-01
• Status Verified: 2012-06
• Study First Submitted: 2012-06-28
• Study First Submitted QC: 2012-06-28
• Last Update Submitted: 2012-06-28
• Study First Posted: 2012-06-29
• Last Update Posted: 2012-06-29
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

University Hospital Zurich, Division of Internal Medicine; 🇨🇭 Zurich, ZH, Switzerland