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Real Life Use of Omalizumab in Chronic Urticaria

NCT04584190 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 700

Last updated 2020-10-12

No results posted yet for this study

Summary

Chronic urticaria affects up to 1% of the population. Chronic urticaria refractory to updosing antihistamines can benefit from OMALIZUMAB, which is an anti-IgE IgG1 monoclonal antibody administrated every 4 weeks subcutaneously which represents a cost of nearly 800€/month excluding nurse fees. Efficacy and good tolerance have already been demonstrated in real-life large cohorts of patients. A 6 months treatment duration is proposed before evaluating the efficacy and discontinuating the treatment in the absence of adequate response. Mean duration of chronic urticaria is 3 to 5 years with high standard deviations. Therefore, optimal duration of treatment with OMALIZUMAB is unknown and discontinuation modalities differ between physicians.

The aim of this study is to evaluate the mean duration between initiation and first discontinuation of OMALIZUMAB in patients treated for chronic urticaria and explore the different factors influencing this duration and its outcome.

Conditions

  • Chronic Urticaria

Sponsors & Collaborators

  • Lyon Civil Hospitals - Lyon Sud Hospital Center

    collaborator UNKNOWN

  • Tenon Hospital, Paris

    collaborator OTHER

  • Nantes University Hospital

    collaborator OTHER

  • University Hospital, Grenoble

    collaborator OTHER

  • University Hospital, Rouen

    collaborator OTHER

  • Lille University Hospital

    collaborator UNKNOWN

  • University Hospital, Bordeaux

    collaborator OTHER

  • Centre Hospitalier Universitaire de Saint Etienne

    collaborator OTHER

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Aurélie Du Thanh, MD, PhD · University Hospitals of Montpellier

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2020-11-30
Completion
2020-12-30

Countries

  • France

Study Locations

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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 NCT04584190 on ClinicalTrials.gov