Rituximab-induced Pulmonary Function Changes
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Purpose
Measuring lung function (FVC, FEV1, DLCO) before, during and after treatment with rituximab in patients with rheumatoid arthritis or inflammatory myositis.
| Condition | Intervention |
|---|---|
|
Rheumatoid Arthritis Inflammatory Myositis |
Other: Lung function measurement |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Rituximab-induced Pulmonary Function Changes - an Observational Study in Patients With Rheumatoid Arthritis and Inflammatory Myositis |
| Estimated Enrollment: | 80 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
-
Other: Lung function measurement
- Spirometry
- CO diffusing capacity
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
Contacts and Locations| Contact: Daniel Franzen, MD | daniel.franzen@usz.ch |
| Switzerland | |
| University Hospital Zurich, Division of Internal Medicine | Recruiting |
| Zurich, ZH, Switzerland, 8091 | |
| Principal Investigator: | Daniel Franzen, MD | University Hospital Zurich, Division of Internal Medicine |
More Information
No publications provided
| Responsible Party: | University of Zurich |
| ClinicalTrials.gov Identifier: | NCT01632124 History of Changes |
| Other Study ID Numbers: | RTX |
| Study First Received: | June 28, 2012 |
| Last Updated: | June 28, 2012 |
| Health Authority: | Switzerland: Ethikkommission |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Myositis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Muscular Diseases |
Neuromuscular Diseases Nervous System Diseases Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 23, 2013