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Completed

NCT Number: NCT04583475

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.

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Key information

Conditions

Spontaneous Urticaria, Chronic Chronic Disease Chronic Urticaria Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hop Claude Huriez Chu Lille

Lille, 59037, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Proportion of patients benefiting from an intensification of OMA treatment at 3 months,

    Time frame: 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 outcomes

  1. Patient characteristics at initiation of OMA treatment expressed as numbers and percentage of total subjects.

    Time frame: at baseline

  2. Proportion of patients benefiting from an intensification of OMA treatment

    Time frame: 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.

  3. Activity of urticaria (score UCT) composite

    Time frame: 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)

  4. Proportion of patients with side effect during follow-up (number and percentage of the total patients)

    Time frame: at 3, 6 and 9 months

  5. Life Quality

    Time frame: at 3, 6 and 9 months

    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.

  6. Life Quality

    Time frame: 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.

  7. The angioedema activity

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: INTENXO

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 12, 2020
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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