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NUCALA® Special Drug Use Investigation (EGPA, Long-term)

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ClinicalTrials.gov Identifier: NCT03557060
Recruitment Status : Active, not recruiting
First Posted : June 14, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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 If a subject has withdrawn from/terminated administration of NUCALA, it will be until the withdrawal/termination. Additionally, to consider the safety and effectiveness of NUCALA administration in subjects who had withdrawn from/terminated due to symptom improvement, 48 weeks (1 year) follow-up investigation should be conducted as much as possible.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.

Condition or disease Intervention/treatment
Churg-Strauss Syndrome Drug: Nucala

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
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


Group/Cohort Intervention/treatment
Subjects receiving NUCALA
Subjects with a diagnosis of EPGA, for which NUCALA is indicated will be included.
Drug: Nucala
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.




Primary Outcome Measures :
  1. Incidence of adverse drug reactions [ Time Frame: Up to 2 years ]
    The information regarding the incidences of adverse drug reactions will be collected.

  2. 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.

  3. Time to EGPA remission and recurrence [ Time Frame: Up to 2 years ]
    The time to EGPA remission and recurrence will be assessed.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects who administered NUCALA for the treatment of EGPA after its approval of indication will be included in the study.
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Japan
GSK Investigational Site
Tokyo, Japan, 107-0052
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03557060     History of Changes
Other Study ID Numbers: 208505
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GlaxoSmithKline:
Nucala
Drug use investigation
EGPA
Long-term

Additional relevant MeSH terms:
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Churg-Strauss Syndrome
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Systemic Vasculitis
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Granuloma
Lymphoproliferative Disorders
Lymphatic Diseases
Autoimmune Diseases
Immune System Diseases