Real Life Use of Omalizumab in Chronic Urticaria

NCT ID: NCT04584190

Last Updated: 2020-10-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 700 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2020-12-30

Brief 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.

Detailed Description

Chronic urticaria affects up to 1% of the population. Rarely, chronic urticaria may be refractory to updosing four-fold antihistamine drugs and then can be improved with subcutaneous OMALIZUMAB. OMALIZUMAB is available for chronic urticaria since 2015. It is an IgG1 monoclonal antibody targeting IgE and administrated every 4 weeks which represent 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 yearss 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.

To accomplish this, the investigators will conduct a restrospective analyse of all patients treated with OMALIZUMAB for chronic urticaria from 2010 to 2020 in the major French hospital reference centers for chronic urticaria management : Paris, Lyon, Grenoble, Lille, Bordeaux, Nantes, Rouen, Saint-Etienne, Montpellier.

Conditions

Chronic Urticaria

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• chronic spontaneous or inducible urticaria
• treated with omalizumab
• at least once between January the 1st 2010 and july 2020.

Exclusion Criteria

• unknown intiation and discontinuation date of omalizumab
• omalizumab initiated for asthma
• other diagnosis (vascularitis, aquagenic pruritus)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lyon Civil Hospitals - Lyon Sud Hospital Center

UNKNOWN

Sponsor Role: collaborator

Tenon Hospital, Paris

OTHER

Sponsor Role: collaborator

Nantes University Hospital

OTHER

Sponsor Role: collaborator

University Hospital, Grenoble

OTHER

Sponsor Role: collaborator

University Hospital, Rouen

OTHER

Sponsor Role: collaborator

Lille University Hospital

UNKNOWN

Sponsor Role: collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: collaborator

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aurélie Du Thanh, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals of Montpellier

Locations

Uh Montpellier

Montpellier, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Julie Litovsky, resident

Role: CONTACT

julie.litovsky@gmail.com

606934527 ext. 33

Aurélie Du Thanh, MD, PhD

Role: CONTACT

a-du_thanh@chu-montpellier.fr

61148890 ext. 33

Facility Contacts

Aurélie Du-Thanh, MD, PhD

Role: primary

a-du_thanh@chu-montpellier.fr

467336906 ext. 33

Other Identifiers

RECHMPL19_0327

Identifier Type: -

Identifier Source: org_study_id