Rituximab-induced Pulmonary Function Changes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Zurich.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01632124
First received: June 28, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by University of Zurich:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Ambulatory patients at University Hospital

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01632124

Contacts
Contact: Daniel Franzen, MD daniel.franzen@usz.ch

Locations
Switzerland
University Hospital Zurich, Division of Internal Medicine Recruiting
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
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:
Myositis
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Neuromuscular Diseases
Nervous System Diseases
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 28, 2014