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BENLYSTA® Spezielle Drogenkonsumuntersuchung

24. April 2026 aktualisiert von: GlaxoSmithKline

BENLYSTA für die Untersuchung des speziellen Drogenkonsums bei intravenöser Injektion/subkutaner Injektion

Ziel dieser Studie ist es, Informationen über die langfristige Sicherheit und Wirksamkeit von Benlysta zur intravenösen Injektion und Benlysta zur subkutanen Injektion (im Folgenden als „Benlysta“ bezeichnet) in der täglichen klinischen Praxis zu sammeln und zu bewerten. Ziel ist es, diese Drogenkonsumuntersuchung (DUI) bei allen Probanden durchzuführen, bis nach der Markteinführung von Benlysta Daten von einer bestimmten Anzahl von Probanden gesammelt wurden. Dabei sollen Daten zur Sicherheit und Wirksamkeit von Benlysta in einem frühen Stadium gesammelt werden, um dadurch die erforderlichen Maßnahmen zu ergreifen für die ordnungsgemäße Verwendung von Benlysta. Ungefähr 600 Probanden werden an dieser Studie teilnehmen. Der Beobachtungszeitraum pro Proband beträgt 52 Wochen ab Beginn der Benlysta-Verabreichung. BENLYSTA ist die eingetragene Marke der Unternehmensgruppe GlaxoSmithKline (GSK).

Studienübersicht

Status

Abgeschlossen

Intervention / Behandlung

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

1514

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

      • Hiroshima, Japan, 730-0001
        • GSK Investigational Site

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Wahrscheinlichkeitsstichprobe

Studienpopulation

Die Studie umfasst alle Probanden, denen Benlysta verabreicht wird. Darüber hinaus werden zu den Probanden, die nach der Markteinführung mit der Verabreichung beginnen, auch diejenigen einbezogen, denen Benlysta bereits vor Vertragsabschluss verabreicht hat, und diejenigen, die bereits zum Zeitpunkt der Diagnose, aufgrund einer Verlegung ins Krankenhaus usw. mit der Verabreichung begonnen haben.

Beschreibung

Einschlusskriterien:

  • Die Studie umfasst alle Probanden, denen Benlysta verabreicht wird. Darüber hinaus werden zu den Probanden, die nach der Markteinführung mit der Verabreichung beginnen, auch diejenigen einbezogen, denen Benlysta bereits vor Vertragsabschluss verabreicht hat, und diejenigen, die bereits zum Zeitpunkt der Diagnose, aufgrund einer Verlegung ins Krankenhaus usw. mit der Verabreichung begonnen haben.

Ausschlusskriterien:

  • N / A

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: Nur Fall
  • Zeitperspektiven: Interessent

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
Benlysta intravenous (IV)
Participants with systemic lupus erythematosus (SLE) received Benlysta via intravenous (IV) administration for 52 weeks as a part of their treatment regimen.
Benlysta was administered
Benlysta subcutaneous (SC)
Participants with SLE received Benlysta via subcutaneous (SC) administration for 52 weeks as a part of their treatment regimen.
Benlysta was administered
Benlysta switched from IV to SC or SC to IV
Participants with SLE received Benlysta for 52 weeks as a part of their treatment regimen, where initial administration was IV but switched to SC, or where the initial administration was SC but switched to IV during the study.
Benlysta was administered
Benlysta IV or SC (Initial route of administration unknown)
Participants with SLE received Benlysta via IV or SC administration for 52 weeks as a part of their treatment regimen. It was unknown whether the initial administration was IV or SC for participants in this arm.
Benlysta was administered

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants With Adverse Drug Reactions (ADRs)
Zeitfenster: From the start of the study intervention (Day 1) up to maximum of 3 years
ADR is defined as a response to a drug which is noxious and unintended, and which occurred at doses normally used in human for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function.
From the start of the study intervention (Day 1) up to maximum of 3 years
Number of Participants With Serious ADR of Events Defined as a Priority Study Matter
Zeitfenster: From the start of the study intervention (Day 1) up to maximum of 3 years
ADR is defined as a response to a drug which is noxious and unintended, and which occurred at doses normally used in human for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function. Following serious ADRs were considered as priority study matter: 1. Serious hypersensitivity, 2. Serious infections (including tuberculosis, pneumonia, pneumocystis pneumonia, sepsis, and opportunistic infection), 3. Reactivation of hepatitis B virus, 4. Progressive multifocal leukoencephalopathy, 5. Interstitial pneumonitis, 6. Malignant tumor, 7. Depression and events related to suicide/self-injury.
From the start of the study intervention (Day 1) up to maximum of 3 years
Change From Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) Score at Week 24
Zeitfenster: Baseline (Day 0) and Week 24
The SELENA-SLEDAI score is a cumulative and weighted index for assessing systemic lupus erythematosus (SLE) disease activity in participants with SLE. It consists of 24 disease descriptors related to signs and symptoms, laboratory tests, and physician's assessment across 9 organ systems. Each descriptor is assigned a weighted score (8 descriptors with a weight of 8 each, 6 descriptors with a weight of 4 each, 7 descriptors with a weight of 2 each, and 3 descriptors with a weight of 1 each) which is added up if the descriptor is observed during a visit or within the preceding 10 days. The total score ranges from 0 (no disease activity) to 105 (all 24 descriptors present simultaneously). A higher score indicates a more significant degree of disease activity. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Baseline (Day 0) and Week 24
Change From Baseline in SELENA SLEDAI Score at Week 52
Zeitfenster: Baseline (Day 0) and Week 52
The SELENA-SLEDAI score is a cumulative and weighted index for assessing systemic lupus erythematosus (SLE) disease activity in participants with SLE. It consists of 24 disease descriptors related to signs and symptoms, laboratory tests, and physician's assessment across 9 organ systems. Each descriptor is assigned a weighted score (8 descriptors with a weight of 8 each, 6 descriptors with a weight of 4 each, 7 descriptors with a weight of 2 each, and 3 descriptors with a weight of 1 each) which is added up if the descriptor is observed during a visit or within the preceding 10 days. The total score ranges from 0 (no disease activity) to 105 (all 24 descriptors present simultaneously). A higher score indicates a more significant degree of disease activity. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Baseline (Day 0) and Week 52
Change From Baseline in Lupus Impact Tracker Score at Week 24
Zeitfenster: Baseline (Day 0) and Week 24
Lupus impact tracker is 10-item patient reported outcome tool to measure impact of systemic lupus erythematosus or its treatment on participants' daily lives. Each answer for items is marked from 0 (none of the time) to 4 (all of the time) points. Lower the lupus impact score, less impact lupus is having on life of participant. Total score was derived by adding up scores of all 10 items. Total score ranges from 0 (less impact on daily life) to 40 (greater impact on daily life). Higher score indicates greater impact of lupus on quality of life.
Baseline (Day 0) and Week 24
Change From Baseline in Lupus Impact Tracker Score at Week 52
Zeitfenster: Baseline (Day 0) and Week 52
Lupus impact tracker is 10-item patient reported outcome tool to measure impact of systemic lupus erythematosus or its treatment on participants' daily lives. Each answer for items is marked from 0 (none of the time) to 4 (all of the time) points. Lower the lupus impact score, less impact lupus is having on life of participant. Total score was derived by adding up scores of all 10 items. Total score ranges from 0 (less impact on daily life) to 40 (greater impact on daily life). Higher score indicates greater impact of lupus on quality of life.
Baseline (Day 0) and Week 52
Change From Baseline in Physician's Global Assessment (PGA) Score at Week 24
Zeitfenster: Baseline (Day 0) and Week 24
The PGA is used to assess the participant's current disease activity by investigator. It was collected on a 10 centimeter (cm) visual analogue scale (VAS). The score ranges from 0 (no activity) to 3 (severe activity). Lower score means no disease activity, higher score means severe disease activity. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Baseline (Day 0) and Week 24
Change From Baseline in PGA Score at Week 52
Zeitfenster: Baseline (Day 0) and Week 52
The PGA is used to assess the participant's current disease activity by investigator. It was collected on a 10 centimeter (cm) visual analogue scale (VAS). The score ranges from 0 (no activity) to 3 (severe activity). Lower score means no disease activity, higher score means severe disease activity. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Baseline (Day 0) and Week 52
Percent Change From Baseline in Mean Daily Steroid Dose at Week 4
Zeitfenster: Baseline (Day 0) and Week 4
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Baseline (Day 0) and Week 4
Percent Change From Baseline in Mean Daily Steroid Dose at Week 8
Zeitfenster: Baseline (Day 0) and Week 8
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Baseline (Day 0) and Week 8
Percent Change From Baseline in Mean Daily Steroid Dose at Week 12
Zeitfenster: Baseline (Day 0) and Week 12
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Baseline (Day 0) and Week 12
Percent Change From Baseline in Mean Daily Steroid Dose at Week 16
Zeitfenster: Baseline (Day 0) and Week 16
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Baseline (Day 0) and Week 16
Percent Change From Baseline in Mean Daily Steroid Dose at Week 20
Zeitfenster: Baseline (Day 0) and Week 20
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Baseline (Day 0) and Week 20
Percent Change From Baseline in Mean Daily Steroid Dose at Week 24
Zeitfenster: Baseline (Day 0) and Week 24
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Baseline (Day 0) and Week 24
Percent Change From Baseline in Mean Daily Steroid Dose at Week 28
Zeitfenster: Baseline (Day 0) and Week 28
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Baseline (Day 0) and Week 28
Percent Change From Baseline in Mean Daily Steroid Dose at Week 32
Zeitfenster: Baseline (Day 0) and Week 32
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Baseline (Day 0) and Week 32
Percent Change From Baseline in Mean Daily Steroid Dose at Week 36
Zeitfenster: Baseline (Day 0) and Week 36
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Baseline (Day 0) and Week 36
Percent Change From Baseline in Mean Daily Steroid Dose at Week 40
Zeitfenster: Baseline (Day 0) and Week 40
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Baseline (Day 0) and Week 40
Percent Change From Baseline in Mean Daily Steroid Dose at Week 44
Zeitfenster: Baseline (Day 0) and Week 44
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Baseline (Day 0) and Week 44
Percent Change From Baseline in Mean Daily Steroid Dose at Week 48
Zeitfenster: Baseline (Day 0) and Week 48
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Baseline (Day 0) and Week 48
Percent Change From Baseline in Mean Daily Steroid Dose at Week 52
Zeitfenster: Baseline (Day 0) and Week 52
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Baseline (Day 0) and Week 52
Number of Participants Who Achieved Lupus Low Disease Activity State (LLDAS) Response Criteria at Week 24
Zeitfenster: At Week 24
LLDAS was defined as a state which, if sustained, was associated with a low likelihood of adverse outcome, considering disease activity and medication safety. The LLDAS response criteria were: (1) Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) less than equal to (<=)4 and no major active organ involvement (renal, central nervous system, cardiopulmonary, vasculitis, and pyrexia) and without hemolytic anemia or active gastrointestinal lesions; (2) no new signs or symptoms as compared to the last SELENA-SLEDAI assessment; (3) PGA score <=1 (33 millimeter); (4) corticosteroid dose <=7.5 milligram (mg)/day at time of assessment; and (5) use of the same immunosuppressant as compared with prior medication. No unapproved immunosuppressant drugs like rituximab, anifrolumab, ustekinumab, or baricitinib were used as concomitant medications.
At Week 24
Number of Participants Who Achieved LLDAS Response Criteria at Week 52
Zeitfenster: At Week 52
LLDAS was defined as a state which, if sustained, was associated with a low likelihood of adverse outcome, considering disease activity and medication safety. The LLDAS response criteria were: (1) Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) less than equal to (<=)4 and no major active organ involvement (renal, central nervous system, cardiopulmonary, vasculitis, and pyrexia) and without hemolytic anemia or active gastrointestinal lesions; (2) no new signs or symptoms as compared to the last SELENA-SLEDAI assessment; (3) PGA score <=1 (33 millimeter); (4) corticosteroid dose <=7.5 milligram (mg)/day at time of assessment; and (5) use of the same immunosuppressant as compared with prior medication. No unapproved immunosuppressant drugs like rituximab, anifrolumab, ustekinumab, or baricitinib were used as concomitant medications.
At Week 52
Change From Baseline in Blood Levels of Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Antibody at Week 24
Zeitfenster: Baseline (Day 0) and Week 24
Blood samples were collected for anti-dsDNA antibody biomarker analysis. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Baseline (Day 0) and Week 24
Change From Baseline in Blood Levels of Anti-dsDNA Antibody at Week 52
Zeitfenster: Baseline (Day 0) and Week 52
Blood samples were collected for anti-dsDNA antibody biomarker analysis. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Baseline (Day 0) and Week 52
Change From Baseline in Blood Levels of Complement Component-3 (C3) and Complement Component-4 (C4) at Week 24
Zeitfenster: Baseline (Day 0) and Week 24
Blood samples were collected from participants to assess C3 and C4 levels. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Baseline (Day 0) and Week 24
Change From Baseline in Blood Levels of Complement Component-3 (C3) and Complement Component-4 (C4) at Week 52
Zeitfenster: Baseline (Day 0) and Week 52
Blood samples were collected from participants to assess C3 and C4 levels. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Baseline (Day 0) and Week 52
Change From Baseline in Blood Levels of Complement Hemolytic Activity at 50% (CH50) at Week 24
Zeitfenster: Baseline (Day 0) and Week 24
Blood samples were collected from participants to assess CH50 concentrations. CH50 is a blood test that measures the overall activity of the complement system, a group of proteins crucial for the immune system's function. Low CH50 levels can be associated with certain infections. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Baseline (Day 0) and Week 24
Change From Baseline in Blood Levels of Complement Hemolytic Activity at 50% (CH50) at Week 52
Zeitfenster: Baseline (Day 0) and Week 52
Blood samples were collected from participants to assess CH50 concentrations. CH50 is a blood test that measures the overall activity of the complement system, a group of proteins crucial for the immune system's function. Low CH50 levels can be associated with certain infections. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Baseline (Day 0) and Week 52
Change From Baseline in Urine Protein/Creatinine Ratio at Week 24
Zeitfenster: Baseline (Day 0) and Week 24
Urine samples were collected from participants to assess Urine Protein/Creatinine Ratio. It is a test that estimates how much protein is being excreted in urine, normalized to creatinine. It's commonly used to assess kidney function and detect proteinuria. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Baseline (Day 0) and Week 24
Change From Baseline in Urine Protein/Creatinine Ratio at Week 52
Zeitfenster: Baseline (Day 0) and Week 52
Urine samples were collected from participants to assess Urine Protein/Creatinine Ratio. It is a test that estimates how much protein is being excreted in urine, normalized to creatinine. It's commonly used to assess kidney function and detect proteinuria. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Baseline (Day 0) and Week 52

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Ermittler

  • Studienleiter: GSK Clinical Trials, GlaxoSmithKline

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

15. Januar 2018

Primärer Abschluss (Tatsächlich)

31. Juli 2025

Studienabschluss (Tatsächlich)

31. Juli 2025

Studienanmeldedaten

Zuerst eingereicht

6. Dezember 2017

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

6. Dezember 2017

Zuerst gepostet (Tatsächlich)

12. Dezember 2017

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

18. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

24. April 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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