NCT01632124

Brief Summary

Measuring lung function (FVC, FEV1, DLCO) before, during and after treatment with rituximab in patients with rheumatoid arthritis or inflammatory myositis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

June 29, 2012

Status Verified

June 1, 2012

Enrollment Period

1.9 years

First QC Date

June 28, 2012

Last Update Submit

June 28, 2012

Conditions

Rheumatoid ArthritisInflammatory Myositis

Interventions

Lung function measurementOTHER

Spirometry and measurement of diffusing capacity for carbon monoxide

Also known as: Spirometry, CO diffusing capacity

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Ambulatory patients at University Hospital

You may qualify if:

  • Age \>18 y
  • Informed consent of patient

You may not qualify if:

  • Pre-existing interstitial pulmonary disease
  • Patients with impaired forced vital capacity (FVC) on spirometry (\<80% predicted) or with impaired DLCO (\<75% predicted).
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Division of Internal Medicine

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Transfer Factor

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

LymphokinesCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Daniel Franzen, MD

    University Hospital Zurich, Division of Internal Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Franzen, MD

CONTACT

daniel.franzen@usz.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2012

First Posted

June 29, 2012

Study Start

January 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

June 29, 2012

Record last verified: 2012-06

Locations

CH(1)