Churg-Strauss Syndrome, Eosinophilic Granulomatosis With Polyangiitis
Conditions
Keywords
Nucala, Drug use investigation, EGPA, Long-term
Brief summary
This study is a drug use investigation program of NUCALA. The objective of this study is to collect and assess information on the safety and effectiveness of the long-term use of NUCALA SC injection in daily clinical practice in subjects with Eosinophilic Granulomatosis with Polyangiitis (EGPA). All subjects who administered NUCALA for the treatment of EGPA after its approval of indication will be included in the study. In addition, after the approval, subjects who had already received NUCALA for EGPA prior to the conclusion of the contract will also be included. Approximately 300 subjects will be included in the study. The observation period per subject is up to 96 weeks (2 years) from the start of NUCALA administration for EGPA at a maximum. If a subject has withdrawn from/terminated administration of NUCALA, it will be until the withdrawal/termination. Additionally, to consider the safety and effectiveness of NUCALA administration in subjects who had withdrawn from/terminated due to symptom improvement, 48 weeks (1 year) follow-up investigation should be conducted as much as possible. The total study duration will be approximately 3 years (2 years observation period and 1 year follow-up) from the approval of EGPA indication to the lifting of approval condition. NUCALA is a registered trademark of the GlaxoSmithKline \[GSK\] group of companies.
Interventions
DRUGNucala
NUCALA injections will be administered to eligible subjects with diagnosis of EGPA. Dose unit, daily dose frequency, date of administration will be at the investigator discretion.
Sponsors
GlaxoSmithKline
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* All subjects who administered NUCALA for the treatment of EGPA after its approval of indication will be included in the study. In addition, after the approval, subjects who had already received NUCALA for EGPA prior to the conclusion of the contract will also be included. * Subjects who had been registered to NCT03028480 for bronchial asthma, but had a change in treatment purpose from bronchial asthma to EGPA during the observation period
Exclusion criteria
* Not applicable.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Drug Reactions (ADRs) | Up to 96 Weeks | ADR is defined as adverse events for which a causal relationship with the drug was not ruled out. |
| Response Rate Based on Global Assessment of Effectiveness | Up to 96 Weeks | Response rate is the percentage of participants assessed as "effective" based on the course of subjective symptoms and clinical symptoms. Response rate was calculated as number of participants showing response to the NUCALA treatment divided by total number of participants on treatment\*100. Percentage values are rounded-off. |
| Time to EGPA Relapse | Up to 96 Weeks | EGPA relapse was defined as conditions meeting any of the following 3 criteria in participants presenting with worsening of EGPA (newly developed symptoms or worsening of existing symptoms), and the presence or absence of relapse and the time to the first relapse were evaluated: 1. corticosteroid administration newly started or a corticosteroid dose increased; 2. immunosuppressant administration newly started or an immunosuppressant dose increased; 3. hospitalization for the treatment of EGPA. Participants were considered responder for EGPA relapse if they met with any one of the three criteria mentioned above. |
Countries
Japan
Contacts
STUDY_DIRECTORGSK Clinical Trials
GlaxoSmithKline
Participant flow
Recruitment details
This non-interventional study aims to collect and assess the information on the safety and effectiveness of the long-term use of NUCALA in daily clinical practice in participants with Eosinophilic Granulomatosis with Polyangiitis (EGPA).
Pre-assignment details
A total of 4115 participants were enrolled in the study; however, 836 participants were included in Safety Analysis Population. Safety Analysis Population consisted of the participants with locked case report form \[CRF\]. It includes participants that do not fall under the safety analysis exclusion criteria.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 59.1 YEARS STANDARD_DEVIATION 14.9 |
| Region of Enrollment Japan | 836 Participants |
| Sex: Female, Male Female | 488 Participants |
| Sex: Female, Male Male | 348 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 836 |
| other Total, other adverse events | 46 / 836 |
| serious Total, serious adverse events | 15 / 836 |
Outcome results
None listed