Real Life Use of Omalizumab in Chronic Urticaria

NCT04584190 | Unknown

• 1 other identifier: RECHMPL19_0327
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Urticaria

Keywords

Chronic urticaria treated with OMALIZUMAB

Outcome Measures

Primary Outcomes (1)

• duration between initiation and first discontinuation of OMALIZUMAB

  assessed at the time of inclusion Description: duration between initiation and first discontinuation of OMALIZUMAB

  1 day

Secondary Outcomes (6)

• predictive factors of duration between initiation and first discontinuation of omalizumab

  1 day

• efficacy of omalizumab and relapse at discontinuation

  1 day

• discontinuation cause

  1 day

• rechallenge with omalizumab and efficacy

  1 day

• persistance of antihistamine intake at 1year, 2 years and 3 years

  at 1year, 2years and 3years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

French referal hospital centers of chronic urticaria managment

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Lyon Civil Hospitals - Lyon Sud Hospital Center: collaborator
• Tenon Hospital, Paris: collaborator
• Nantes University Hospital: collaborator
• University Hospital, Grenoble: collaborator
• University Hospital, Rouen: collaborator
• Lille University Hospital: collaborator
• University Hospital, Bordeaux: collaborator
• Centre Hospitalier Universitaire de Saint Etienne: collaborator

Study Sites (1)

Uh Montpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Chronic Urticaria

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aurélie Du Thanh, MD, PhD

  University Hospitals of Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Litovsky, resident

CONTACT

606934527; julie.litovsky@gmail.com

Aurélie Du Thanh, MD, PhD

CONTACT

61148890; a-du_thanh@chu-montpellier.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 12, 2020
• Study Start: July 1, 2020
• Primary Completion: November 30, 2020
• Study Completion: December 30, 2020
• Last Updated: October 12, 2020

Record last verified: 2020-10

Locations

FR (1)