Evaluate the proportion of patients with an urticaria control test \[UCT\] score of greater than or equal to 12 at Week 12.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
136
sub cutaneous injections of 300 mg every 4 weeks until Week 8.
Novartis Investigative Site
Paris, Cedex 10, France
Percent of Participants With an Urticaria Control Test [UCT] Score of Greater Than or Equal to 12
Number of participants with an Urticaria Control Test score of greater than or equal to 12 at Week 12 The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control.
Time frame: WEEK 12
Percent of Participants With UAS7≤6 (Patients Achieving Disease Control), in Adult Patients With CSU, With or Without the Presence of Angioedema
2 patients with angioedema status were missing at baseline and not included
Time frame: WEEK 12
CSU Disease Activity Using the Urticaria Activity Score (UAS7), With or Without the Presence of Angioedema
A total score of UAS7 is calculated by adding for 7 days the daily UAS. The UAS7 is the sum of the daily UAS over 7 days before baseline and W12. The UAS7 score ranges from 0 to 42 with higher scores reflecting higher activity of the disease. Scores were categorized into five diseases states : urticaria-free (score =0), well-controlled (scores 1-6), mild (scores 7-15), moderate (scores 16-27) and severe urticaria (scores 28-42).
Time frame: baseline and week 12
Urticaria Control Test (UCT) Score According to the Presence of Angioedema at Baseline and Week 12
The UCT is a questionnaire collecting retrospective information over the last 4 weeks before baseline and W12. The UCT score ranges from 0 to 16 with higher scores reflecting lower control of the disease. A score of ≥12 indicates well-controlled urticaria.
Time frame: baseline and week 12
Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 16, With or Without the Presence of Angioedema
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Novartis Investigative Site
Limoges, Haute Vienne, France
Novartis Investigative Site
Toulon, Val De Marne, France
Novartis Investigative Site
Angers, France
Novartis Investigative Site
Argenteuil, France
Novartis Investigative Site
Besançon, France
Novartis Investigative Site
Bobigny, France
Novartis Investigative Site
Bordeaux, France
Novartis Investigative Site
Châlons-en-Champagne, France
Novartis Investigative Site
Clermont-Ferrand, France
...and 19 more locations
The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control.
Time frame: week 16
Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 20, With or Without the Presence of Angioedema
The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control.
Time frame: week 20
Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 24, With or Without the Presence of Angioedema
The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control
Time frame: week 24
Control of the CSU Using the UCT Score for Patients in Extension Treatment Period Phase at Week 28, With or Without the Presence of Angioedema
The UCT is a simple 4-item tool. A score between 0 and 4 is assigned to every answer option. Subsequently, the scores for all 4 questions are summed up. Accordingly, the minimum and maximum UCT scores are 0 and 16, with 16 points indicating complete disease control.
Time frame: week 28
The Quality of Life Using the Chronic Urticaria Quality of Life (CU-QoL) Questionnaire
The Cu-QoL is a questionnaire collecting retrospective information over the last 2 weeks before baseline and W12. The CU-QoL total score is transformed to range from 0 to 100, with higher scores indicating worse Health Related Quality of life.
Time frame: baseline and week 12
The Angioedema Quality of Life (AE-QoL)
The angioedema Quality of Life Questionnaire is a valuable tool to assess changes of QoL impairment in angioedema patients. The results of all the answered questions are summed up and transferred to a scale ranging from 0 to 100, with higher scores indicative of a higher QoL impairment
Time frame: baseline and week 12
The Dermatology Life Quality Index (DLQI)
The Dermatology life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. It is designed for people aged 16 years and above. Each question is scored from 0 to 3, giving a possible score range form 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life).
Time frame: baseline and week 12
Angioedema Activity Using the Angioedema Activity Score (AAS)
The Angioedema Activity Score (AAS) was completed by patients on a daily basis. The AAS is a validated questionnaire to determine the severity and impact of the angioedema episode. Te daily AAS values are added over 7 days before baseline and W12. Weekly AAS (AAS7) scores range from 0 to 105, with higher scores indicative of a higher disease activity.
Time frame: baseline and week 12