Chronic UrticariaXO-DSNCT04584190
Real Life Use of Omalizumab in Chronic Urticaria
An observational study of Chronic Urticaria, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Urticaria
- How many people
- 700 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2020to 30 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: French referal hospital centers of chronic urticaria managment
Who may be able to join
- chronic spontaneous or inducible urticaria
- treated with omalizumab
- at least once between January the 1st 2010 and july 2020.
Who cannot join
- unknown intiation and discontinuation date of omalizumab
- omalizumab initiated for asthma
- other diagnosis (vascularitis, aquagenic pruritus)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Uh Montpellier
Montpellier, 34295
Aurélie Du-Thanh, MD, PhD, 467336906 ext. 33, a-du_thanh@chu-montpellier.fr
About this study
Official title: Drug Survival of Omalizumab in Chronic Urticaria : a Retrospective Multicentric Study
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.
Read the 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
- Keywords
- Chronic urticaria treated with OMALIZUMAB
- Medical subject headings
- Chronic Urticaria
What is being measured
The primary outcome is the main question the study is designed to answer.
duration between initiation and first discontinuation of OMALIZUMAB
assessed at the time of inclusion Description: duration between initiation and first discontinuation of OMALIZUMAB
Measured: 1 day
Secondary outcomes (6)
predictive factors of duration between initiation and first discontinuation of omalizumab
predictive factors of duration between initiation and first discontinuation of omalizumab
Measured: 1 day
efficacy of omalizumab and relapse at discontinuation
efficacy of omalizumab and relapse at discontinuation
Measured: 1 day
discontinuation cause
discontinuation cause
Measured: 1 day
rechallenge with omalizumab and efficacy
rechallenge with omalizumab and efficacy
Measured: 1 day
persistance of antihistamine intake at 1year, 2 years and 3 years
persistance of antihistamine intake at 1year, 2 years and 3 years
Measured: at 1year, 2years and 3years
mid and long-term tolerance of omalizumab.
mid and long-term tolerance of omalizumab.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start1 Jul 2020
- Primary completion30 Nov 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic UrticariaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Lyon Sud Hospital Center, Tenon Hospital, Paris, Nantes University Hospital, University Hospital, Grenoble, University Hospital, Rouen, University Hospital, Lille, University Hospital, Bordeaux, Centre Hospitalier Universitaire de Saint Etienne
- Responsible party
- Sponsor
- Investigators
- Aurélie Du Thanh, MD, PhD, Principal investigator, University Hospitals of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584190
- Sponsor's protocol ID
- RECHMPL19_0327
- Acronym
- XO-DS
- Status last verified
- Oct 2020
- First submitted
- 6 Oct 2020
- Last updated
- 12 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Survival of Omalizumab in Chronic Urticaria : a Retrospective Multicentric Study
- ClinicalTrials.gov ID
- NCT04584190
- Acronym / sponsor ID
- XO-DS / RECHMPL19_0327
- Conditions
- Chronic Urticaria
- Keywords
- Chronic urticaria treated with OMALIZUMAB
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Lyon Sud Hospital Center, Tenon Hospital, Paris, Nantes University Hospital, University Hospital, Grenoble, University Hospital, Rouen, University Hospital, Lille, University Hospital, Bordeaux, Centre Hospitalier Universitaire de Saint Etienne
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 12 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- French referal hospital centers of chronic urticaria managment
Key inclusion criteria (3 listed)
- chronic spontaneous or inducible urticaria
- treated with omalizumab
- at least once between January the 1st 2010 and july 2020.
Key exclusion criteria (3 listed)
- unknown intiation and discontinuation date of omalizumab
- omalizumab initiated for asthma
- other diagnosis (vascularitis, aquagenic pruritus)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
duration between initiation and first discontinuation of OMALIZUMAB
Time frame: 1 day
assessed at the time of inclusion Description: duration between initiation and first discontinuation of OMALIZUMAB
6 secondary outcomes
predictive factors of duration between initiation and first discontinuation of omalizumab
Time frame: 1 day
efficacy of omalizumab and relapse at discontinuation
Time frame: 1 day
discontinuation cause
Time frame: 1 day
rechallenge with omalizumab and efficacy
Time frame: 1 day
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.
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurélie Du Thanh, MD, PhD principal investigator
University Hospitals of Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Urticaria, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie Litovsky, resident (606934527 ext. 33, julie.litovsky@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration between initiation and first discontinuation of OMALIZUMAB (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2020.