An observational study in Chronic Urticaria, sponsored by University Hospital, Montpellier. Status unknown at 1 site in France. Per ClinicalTrials.gov, last updated 2020-10-12.
Sponsored by University Hospital, Montpellier · Observational
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.
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.
237 studies on the registry are indexed under Urticaria; 26 are open to participants now.
This study's planned enrollment of 700 is above the median of 162 across 52 observational studies indexed under Urticaria.
Browse Urticaria studies →University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.
Counted across the registry records on this site, refreshed daily.
French referal hospital centers of chronic urticaria managment
Exclusion criteria:
duration between initiation and first discontinuation of OMALIZUMAB
assessed at the time of inclusion Description: duration between initiation and first discontinuation of OMALIZUMAB
Time frame: 1 day
predictive factors of duration between initiation and first discontinuation of omalizumab
predictive factors of duration between initiation and first discontinuation of omalizumab
Time frame: 1 day
efficacy of omalizumab and relapse at discontinuation
efficacy of omalizumab and relapse at discontinuation
Time frame: 1 day
discontinuation cause
discontinuation cause
Time frame: 1 day
rechallenge with omalizumab and efficacy
rechallenge with omalizumab and efficacy
Time frame: 1 day
persistance of antihistamine intake at 1year, 2 years and 3 years
persistance of antihistamine intake at 1year, 2 years and 3 years
Time frame: at 1year, 2years and 3years
mid and long-term tolerance of omalizumab.
mid and long-term tolerance of omalizumab.
Time frame: 1 day
Plan to share: Undecided — NC
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This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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University Hospital, Montpellier