NUCALA® Special Drug Use Investigation (EGPA, Long-term)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03557060|
Recruitment Status : Active, not recruiting
First Posted : June 14, 2018
Last Update Posted : September 10, 2018
|Condition or disease||Intervention/treatment|
|Churg-Strauss Syndrome||Drug: Nucala|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||NUCALA ® Subcutaneous Injection Special Drug Use Investigation (EGPA, Long-term）|
|Actual Study Start Date :||June 25, 2018|
|Estimated Primary Completion Date :||May 31, 2024|
|Estimated Study Completion Date :||May 31, 2024|
Subjects receiving NUCALA
Subjects with a diagnosis of EPGA, for which NUCALA is indicated will be included.
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.
- Incidence of adverse drug reactions [ Time Frame: Up to 2 years ]The information regarding the incidences of adverse drug reactions will be collected.
- Response rate based on global assessment of effectiveness [ Time Frame: Up to 2 years ]The response rate is the percentage of subjects assessed as effective. Effectiveness will be comprehensively assessed by any of effective or not effective at Week 12, 48 after the start of NUCALA administration, end of the observation period, or withdrawal/termination, based on the course of subjective symptoms, course of clinical symptoms, from the start date of administration to the end of the observation period. If effectiveness cannot be determined for some reasons, it should be assessed as indeterminable and its reasons should be recorded on the CRF.
- Time to EGPA remission and recurrence [ Time Frame: Up to 2 years ]The time to EGPA remission and recurrence will be assessed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03557060
|GSK Investigational Site|
|Tokyo, Japan, 107-0052|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|