Special Drug Use Observational Study of Xolair in Patients With Severe to Most Severe Seasonal Allergic Rhinitis Aged ≥ 12 Years and < 18 Years Whose Symptoms Were Inadequately Controlled Despite to Conventional Therapies

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04648930

Collaborator

(none)

Enrollment

Locations

24.1

Anticipated Duration (Months)

3.1

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multicenter, uncontrolled, open-label, special drug use study to investigate the safety and efficacy of Xolair by collecting data in its clinical setting in patients with severe to most severe seasonal allergic rhinitis aged ≥ 12 years and < 18 years whose symptoms were inadequately controlled despite to conventional therapies and used Xolair.

Condition or Disease	Intervention/Treatment	Phase
Allergic Rhinitis	Drug: Xolair

Detailed Description

The observation period will last for up to 24 weeks, with Day 1 defined as the start date of Xolair treatment. It should be noted that, because the duration of Xolair treatment depends on the pollen dispersal situation and other factors, patients who complete or discontinue Xolair treatment before the visit at 24 weeks after the start of treatment will be followed up until the date of last dose of Xolair + 30 days, and the results will be recorded in the CRF.

Study Design

Study Type:

Observational

Actual Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Special Drug Use Observational Study of Xolair in Patients With Severe to Most Severe Seasonal Allergic Rhinitis Aged ≥ 12 Years and < 18 Years Whose Symptoms Were Inadequately Controlled Despite to Conventional Therapies

Actual Study Start Date :

Jan 27, 2021

Anticipated Primary Completion Date :

Jan 31, 2023

Anticipated Study Completion Date :

Jan 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Xolair S.C. Injection	Drug: Xolair There is no treatment allocation. Patients administered Xolair by prescription that have started before inclusion of the patient into the study will be enrolled. Other Names: Omalizumab

Arm

Intervention/Treatment

Xolair

S.C. Injection

Drug: Xolair

There is no treatment allocation. Patients administered Xolair by prescription that have started before inclusion of the patient into the study will be enrolled.

Other Names:

Omalizumab

Outcome Measures

Primary Outcome Measures

Proportions of patients with Adverse events (AEs), Serious AEs, AEs leading to discontinuation of Xolair treatment, Adverse drug reactions (ADRs), Serious ADRs, ADRs leading to discontinuation of Xolair treatment [up to 24 weeks]
The number of patients with each events and incidences (%) will be calculated by System Organ Class (SOC) and Preferred Term (PT). SAEs are defined as AEs meeting the criteria of seriousness and adverse events with a fatal outcome. ADRs are defined as AEs for which a causal relationship with Xolair is not ruled out by the investigator.

Secondary Outcome Measures

Overall improvement rate of disease by physicians [week 24]
The investigator will comprehensively assess the therapeutic effect of Xolair on seasonal allergic rhinitis at the last visit on the basis of the patient's condition before the start of Xolair and during the clinical course thereafter, as "markedly improved", "moderately improved", "slightly improved", "no change" or "worsened"
Disease severity of seasonal allergic rhinitis [Up to 24 weeks]
The investigator will comprehensively assess the severity of seasonal allergic rhinitis on the basis of each seasonal allergic rhinitis symptom, test results, and the degree of visually examined local changes at each visit, as "very severe", "severe", "moderate", "mild" or "no symptom"
Individual symptom severity of seasonal allergic rhinitis [Up to 24 weeks]
The investigator will assess the severity of each seasonal allergic rhinitis symptom(sneezing, nasal discharge, nasal obstruction, difficulty in daily activity) at each visit in accordance with the criteria in the Practical Guideline for the Management of Allergic Rhinitis in Japan (2016)

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients who used Xolair in accordance with the instructions of package insert
Patients aged ≥ 12 years and < 18 years at the start of Xolair
Patients who used Xolair for the following indication:

Indication: seasonal allergic rhinitis (only patients with severe to most severe symptoms whose symptoms were inadequately controlled despite to conventional therapies) 4. Patients having provided written consent to participate in this study before the start of Xolair in the relevant pollen season, in person and from their legally acceptable representative (legal representative)

Exclusion Criteria:

Patients with a history of hypersensitivity to any of the Xolair ingredients

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Inazawa	Aichi	Japan	495-0002
2	Novartis Investigative Site	Ichikawa-city	Chiba	Japan	272-0143
3	Novartis Investigative Site	Inzai	Chiba	Japan	270-1337
4	Novartis Investigative Site	Chikusei City	Ibaraki	Japan	308-0031
5	Novartis Investigative Site	Sagamihara-city	Kanagawa	Japan	252-0392
6	Novartis Investigative Site	Sagamihara	Kanagawa	Japan	252-0231
7	Novartis Investigative Site	Neyagawa	Osaka	Japan	572-0082
8	Novartis Investigative Site	Chiyoda	Tokyo	Japan	102-0093
9	Novartis Investigative Site	Fukuoka		Japan	813 0043
10	Novartis Investigative Site	Kumamoto		Japan	860-0814
11	Novartis Investigative Site	Kyoto		Japan	604-0837
12	Novartis Investigative Site	Kyoto		Japan	604-8152
13	Novartis Investigative Site	Nagasaki		Japan	850-0057
14	Novartis Investigative Site	Osaka		Japan	544-0033
15	Novartis Investigative Site	Osaka		Japan	545-8586
16	Novartis Investigative Site	Saitama		Japan	331-0802