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ClinicalTrials.gov Identifier: NCT01632124
Recruitment Status : Unknown
Verified June 2012 by University of Zurich. Recruitment status was: Recruiting
Measuring lung function (FVC, FEV1, DLCO) before, during and after treatment with rituximab in patients with rheumatoid arthritis or inflammatorymyositis.
Condition or disease
Other: Lung function measurement
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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Ambulatory patients at University Hospital
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).