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Rituximab-induced Pulmonary Function Changes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01632124
Recruitment Status : Unknown
Verified June 2012 by University of Zurich.
Recruitment status was:  Recruiting
First Posted : June 29, 2012
Last Update Posted : June 29, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Inflammatory Myositis Other: Lung function measurement

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.

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Rituximab-induced Pulmonary Function Changes - an Observational Study in Patients With Rheumatoid Arthritis and Inflammatory Myositis
Study Start Date : January 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Intervention Details:
  • Other: Lung function measurement
    Spirometry and measurement of diffusing capacity for carbon monoxide
    Other Names:
    • Spirometry
    • CO diffusing capacity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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).
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01632124

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Contact: Daniel Franzen, MD

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University Hospital Zurich, Division of Internal Medicine Recruiting
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
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Principal Investigator: Daniel Franzen, MD University Hospital Zurich, Division of Internal Medicine
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Responsible Party: University of Zurich Identifier: NCT01632124    
Other Study ID Numbers: RTX
First Posted: June 29, 2012    Key Record Dates
Last Update Posted: June 29, 2012
Last Verified: June 2012
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Neuromuscular Diseases
Nervous System Diseases