Spontaneous Urticaria, Chronic Clinical Trial
— INTENXOOfficial title:
Real-life Study of How to Intensify Treatment With Xolair (OMALIZUMAB) in Chronic Spontaneous Urticaria
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.
| Status | Recruiting |
| Enrollment | 150 |
| Est. completion date | March 2023 |
| Est. primary completion date | March 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Hop Claude Huriez Chu Lille | Lille |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Lille |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of patients benefiting from an intensification of OMA treatment 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. | At 3 months | |
| Secondary | Patient characteristics at initiation of OMA treatment expressed as numbers and percentage of total subjects. | at baseline | ||
| Secondary | Proportion of patients benefiting from an intensification of OMA treatment | 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. | Baseline, at 6 months and at 9 months | |
| Secondary | Activity of urticaria (score UCT) composite | 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) |
at 3, 6 and 9 months | |
| Secondary | Proportion of patients with side effect during follow-up (number and percentage of the total patients) | at 3, 6 and 9 months | ||
| Secondary | Life Quality | Comparison of the percentage and absolute change in DLQI score (Dermatology Life Quality Index score) versus baseline between patients who received a dose escalation and patients who received a standard dose of OMA.
The DLQI is a dermatology-specific quality of life scale validated in the UCS. It assesses the impact of the disease on different aspects of life such as symptoms, feelings, activities of daily living, leisure, work, school and personal relationships. The total score ranges from 0 to 30 points: 0-1 = No effect of urticaria on the patient's life; between 2-5 = Mild effect of urticaria on the patient's life; between 6-10 = Moderate effect of urticaria on the patient's life; between 11-20 = Very strong effect of urticaria on the patient's life and between 21-30 = Extremely strong effect of urticaria on the patient's life. |
at 3, 6 and 9 months | |
| Secondary | Life Quality | 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. |
at 3, 6 and 9 months | |
| Secondary | The angioedema activity | 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). |
at 3, 6 and 9 months |