MedTrace Logo

The REALITY Study - a Real-life Long-term Analysis of Xolair Therapy

NCT01776177 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 240

Last updated 2013-01-28

No results posted yet for this study

Summary

The primary objective is to assess the clinical effectiveness of long-term omalizumab therapy in 240 patients treated over an 8 year period in a real-life clinical setting and to compare the pre- and post-treatment clinical characteristics to identify and better understand the markers of response to omalizumab.

To date, there are no established criteria for identifying 'response' to omalizumab therapy. Currently, the commonly accepted clinical criterion for omalizumab treatment response is the physician's overall assessment, GETE (Global Evaluation of Treatment Effectiveness). Most clinical trials have evaluated the efficacy of omalizumab treatment after a 16 week treatment period and lack the impact of long-term omalizumab therapy.

Investigators propose multiple approach modules to better assess and identify 'response' and to define 'responders' to omalizumab and evaluate the long-term impact in a real-world clinical practice. Besides evaluating individual outcome variables, it is important to attempt the 'clustering of variables' to further investigate if any baseline clinical phenotypes are predictive of better response enabling us to refine the patient population who will gain most benefit from therapy.

Conditions

  • Allergic Asthma

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Joseph D. Diaz, MD

    lead INDUSTRY

Principal Investigators

  • Joseph D Diaz, MD · Allergy & Asthma Research Center, San Antonio, TX

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-03-31
Completion
2013-08-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01776177 on ClinicalTrials.gov