Real-life Study of How to Intensify Treatment With Xolair (OMALIZUMAB) in Chronic Spontaneous Urticaria

Recruiting

• Conditions: Spontaneous Urticaria, Chronic

• Registration Number: NCT04583475
• Lead Sponsor: University Hospital, Lille

Brief Summary

This is an observational study whose main objective is to estimate the frequency of patients benefiting from an intensification of AOM treatment at 3 months.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-05
• Study First Submitted QC: 2020-10-05
• Study First Posted: 2020-10-12
• Study Start: 2021-02-25
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-25
• Last Update Posted: 2023-01-26
• Primary Completion: 2023-03
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patient having expressed non-opposition
• Affiliation to a social protection scheme (beneficiary or entitled person)
• Decision by the investigator to initiate, independently of the study, an AOM treatment for Spontaneous Chronic Urticaria that may or may not be associated with an inducible component.

Exclusion Criteria

• Patients < 18 years of age
• Patient who had previously received AOM treatment prior to the inclusion visit
• Patients under guardianship or curatorship
• Pregnant or breastfeeding woman

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients benefiting from an intensification of OMA treatment at 3 months,	At 3 months	defined as an increase in dose (more than 300mg) and/or a reduction in the administration interval to less than 4 weeks.

Secondary Outcome Measures

Name	Time	Method
Patient characteristics at initiation of OMA treatment expressed as numbers and percentage of total subjects.	at baseline
Proportion of patients benefiting from an intensification of OMA treatment	Baseline, at 6 months and at 9 months	Percentage of patients who received an OMA dose greater than 300mg per dose and/or an administration interval of less than 4 weeks apart at 0, 6 and 9 months.
Proportion of patients with side effect during follow-up (number and percentage of the total patients)	at 3, 6 and 9 months
Life Quality	at 3, 6 and 9 months	Comparison of the percentage and absolute change in Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) score versus baseline between patients who received a dose escalation and patients who received a standard dose of OMA.; The Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) for Chronic Urticaria Quality of Life Questionnaire is a tool specifically designed to assess the quality of life of patients with Chronic Urticaria Syndrome and its variant for angioedema (AE-QoL). It is a 23-item self-administered questionnaire that asks patients to rate how often each problem affects them on a Likert scale with several options (minimum 1: not at all; maximum 5: a lot). Higher scores indicate poorer quality of life.
Activity of urticaria (score UCT) composite	at 3, 6 and 9 months	* Proportion of patients (numbers and percentage of total) with Satisfactory response (UCT≥12 score); * Proportion of patients (numbers and percentage of total) with a complete response (UCT=16 score); * Proportion of patients (numbers and percentage of total) with unsatisfactory response (UCT score\<12)
The angioedema activity	at 3, 6 and 9 months	Comparison of the percentage and absolute change in AAS28score versus baseline between patients who received a dose escalation and patients who received a standard dose of OMA.; The AAS for angioedema activity score developed by Weller et al. consists of 5 questions to assess the severity of angioedema episodes. A severity grade increasing between 0 and 3 is assigned for each question. The final score corresponds to the sum of the scores for each day over a 28-day period (ASA28) and ranges from 0-420 (ASA28).

Trial Locations

Locations (1)

Hop Claude Huriez Chu Lille; 🇫🇷 Lille, France