XO-DS: Real Life Use of Omalizumab in Chronic Urticaria

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Recruiting

CT.gov ID

NCT04584190

Collaborator

Lyon Civil Hospitals - Lyon Sud Hospital Center (Other), Tenon Hospital, Paris (Other), Nantes University Hospital (Other), University Hospital, Grenoble (Other), University Hospital, Rouen (Other), Lille University Hospital (Other), University Hospital, Bordeaux (Other), Centre Hospitalier Universitaire de Saint Etienne (Other)

700

Enrollment

Location

Anticipated Duration (Months)

117.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Urticaria

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.

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

700 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

Drug Survival of Omalizumab in Chronic Urticaria : a Retrospective Multicentric Study

Actual Study Start Date :

Jul 1, 2020

Anticipated Primary Completion Date :

Nov 30, 2020

Anticipated Study Completion Date :

Dec 30, 2020

Outcome Measures

Primary Outcome Measures

duration between initiation and first discontinuation of OMALIZUMAB [1 day]
assessed at the time of inclusion Description: duration between initiation and first discontinuation of OMALIZUMAB

Secondary Outcome Measures

predictive factors of duration between initiation and first discontinuation of omalizumab [1 day]
predictive factors of duration between initiation and first discontinuation of omalizumab
efficacy of omalizumab and relapse at discontinuation [1 day]
efficacy of omalizumab and relapse at discontinuation
discontinuation cause [1 day]
discontinuation cause
rechallenge with omalizumab and efficacy [1 day]
rechallenge with omalizumab and efficacy
persistance of antihistamine intake at 1year, 2 years and 3 years [at 1year, 2years and 3years]
persistance of antihistamine intake at 1year, 2 years and 3 years
mid and long-term tolerance of omalizumab. [1 day]
mid and long-term tolerance of omalizumab.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Uh Montpellier	Montpellier		France	34295

Investigators

Principal Investigator: Aurélie Du Thanh, MD, PhD, University Hospitals of Montpellier

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Montpellier

ClinicalTrials.gov Identifier:

NCT04584190

Other Study ID Numbers:

RECHMPL19_0327

First Posted:

Oct 12, 2020

Last Update Posted:

Oct 12, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Montpellier

Chronic urticaria treated with OMALIZUMAB

Additional relevant MeSH terms:

Urticaria

Chronic Urticaria

Study Results

No Results Posted as of Oct 12, 2020