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Enquête spéciale sur l'utilisation de médicaments BENLYSTA®

24 avril 2026 mis à jour par: GlaxoSmithKline

BENLYSTA pour injection intraveineuse/injection sous-cutanée Enquête spéciale sur l'utilisation de drogues

L'objectif de cette étude est de collecter et d'évaluer les informations sur l'innocuité et l'efficacité à long terme de Benlysta pour injection intraveineuse et de Benlysta pour injection sous-cutanée (ci-après dénommé « Benlysta ») dans la pratique clinique quotidienne. Le but de mener cette enquête sur l'usage de drogues (DUI) chez tous les sujets jusqu'à ce que les données soient accumulées à partir d'un certain nombre de sujets après la commercialisation de Benlysta, des données seront collectées sur la sécurité et l'efficacité de Benlysta à un stade précoce et ainsi de prendre les mesures nécessaires pour une utilisation correcte de Benlysta. Environ 600 sujets seront inscrits à cette étude. La période d'observation par sujet sera de 52 semaines à compter du début de l'administration de Benlysta. BENLYSTA est la marque déposée du groupe de sociétés GlaxoSmithKline (GSK).

Aperçu de l'étude

Statut

Statut

Indique le statut de recrutement actuel ou le statut d'accès étendu.
Complété

Les conditions

Les conditions

La maladie, le trouble, le syndrome, la maladie ou la blessure à l'étude. Sur ClinicalTrials.gov, les conditions peuvent également inclure d'autres problèmes liés à la santé, tels que la durée de vie, la qualité de vie et les risques pour la santé.

Intervention / Traitement

Intervention / Traitement

Processus ou action faisant l'objet d'une étude clinique. Les interventions comprennent les médicaments, les dispositifs médicaux, les procédures, les vaccins et d'autres produits expérimentaux ou déjà disponibles. Les interventions peuvent également inclure des approches non invasives, telles que l'éducation ou la modification du régime alimentaire et de l'exercice.

Type d'étude

Type d'étude

Décrit la nature d'une étude clinique. Les types d'études comprennent les études interventionnelles (également appelées essais cliniques), les études observationnelles (y compris les registres de patients) et l'accès élargi.
Observationnel

Inscription (Réel)

Inscription

Le nombre de participants à une étude clinique. L'inscription "prévue" est le nombre cible de participants dont les chercheurs ont besoin pour l'étude.
1514

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Coordonnées de l'étude

Le nom et les coordonnées de la personne qui peut répondre aux questions d'inscription à une étude clinique. Chaque lieu où l'étude est menée peut également avoir un contact spécifique, qui peut être mieux à même de répondre à ces questions.

Sauvegarde des contacts de l'étude

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Critère d'éligibilité

Les principales exigences que doivent remplir les personnes qui souhaitent participer à une étude clinique ou les caractéristiques qu'elles doivent avoir. Les critères d'éligibilité comprennent à la fois des critères d'inclusion (qui sont requis pour qu'une personne participe à l'étude) et des critères d'exclusion (qui empêchent une personne de participer). Les types de critères d'éligibilité incluent si une étude accepte des volontaires sains, a des exigences d'âge ou de groupe d'âge, ou est limitée par le sexe.

Âges éligibles pour étudier

  • Enfant
  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

L'étude inclura tous les sujets auxquels Benlysta est administré. De plus, parmi les sujets qui commencent l'administration après le lancement, ceux à qui Benlysta a déjà administré avant la conclusion du contrat et ceux qui ont déjà commencé l'administration au moment du diagnostic, en raison d'un transfert hospitalier, etc. seront également inclus.

La description

Critère d'intégration:

  • L'étude inclura tous les sujets auxquels Benlysta est administré. De plus, parmi les sujets qui commencent l'administration après le lancement, ceux à qui Benlysta a déjà administré avant la conclusion du contrat et ceux qui ont déjà commencé l'administration au moment du diagnostic, en raison d'un transfert hospitalier, etc. seront également inclus.

Critère d'exclusion:

  • N / A

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: Cas uniquement
  • Perspectives temporelles: Éventuel

Cohortes et interventions

Groupe / Cohorte

Groupe / Cohorte

Groupe ou sous-groupe de participants à une étude observationnelle dont les résultats biomédicaux ou sanitaires sont évalués.
Intervention / Traitement

Intervention / Traitement

Processus ou action faisant l'objet d'une étude clinique. Les interventions comprennent les médicaments, les dispositifs médicaux, les procédures, les vaccins et d'autres produits expérimentaux ou déjà disponibles. Les interventions peuvent également inclure des approches non invasives, telles que l'éducation ou la modification du régime alimentaire et de l'exercice.
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.
Médicament: Benlysta
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.
Médicament: Benlysta
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.
Médicament: Benlysta
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.
Médicament: Benlysta
Benlysta was administered

Que mesure l'étude ?

Principaux critères de jugement

Principaux critères de jugement

Dans le protocole d'une étude clinique, la mesure de résultat prévue qui est la plus importante pour évaluer l'effet d'une intervention/d'un traitement. La plupart des études cliniques ont un critère de jugement principal, mais certaines en ont plus d'un.
Mesure des résultats
Description de la mesure
Délai
Number of Participants With Adverse Drug Reactions (ADRs)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Parrainer

L'organisation ou la personne qui lance l'étude et qui a autorité et contrôle sur l'étude.
GlaxoSmithKline

Les enquêteurs

Les enquêteurs

Un chercheur impliqué dans une étude clinique. Les termes associés incluent chercheur principal du site, sous-chercheur du site, directeur de l'étude, directeur de l'étude et chercheur principal de l'étude.
  • Directeur d'études: GSK Clinical Trials, GlaxoSmithKline

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

Début de l'étude

La date réelle à laquelle le premier participant a été inscrit à une étude clinique. La date de début "prévue" de l'étude est la date qui, selon les chercheurs, sera la date de début de l'étude.
15 janvier 2018

Achèvement primaire (Réel)

Achèvement primaire

La date à laquelle le dernier participant à une étude clinique a été examiné ou a reçu une intervention pour recueillir les données finales pour le critère de jugement principal. Que l'étude clinique se soit terminée conformément au protocole ou qu'elle ait été terminée n'affecte pas cette date. Pour les études cliniques avec plus d'un critère de jugement principal avec des dates d'achèvement différentes, ce terme fait référence à la date à laquelle la collecte de données est terminée pour tous les critères de jugement principaux. La date d'achèvement primaire "prévue" est la date qui, selon les chercheurs, sera la date d'achèvement primaire de l'étude.
31 juillet 2025

Achèvement de l'étude (Réel)

Achèvement de l'étude

La date à laquelle le dernier participant à une étude clinique a été examiné ou a reçu une intervention/un traitement pour recueillir les données finales pour les mesures de résultats primaires, les mesures de résultats secondaires et les événements indésirables (c'est-à-dire la dernière visite du dernier participant). La date d'achèvement de l'étude "prévue" est la date qui, selon les chercheurs, sera la date d'achèvement de l'étude.
31 juillet 2025

Dates d'inscription aux études

Première soumission

Première soumission

La date à laquelle le promoteur de l'étude ou l'investigateur a soumis pour la première fois un dossier d'étude à ClinicalTrials.gov. Il y a généralement un délai de quelques jours entre la première date de soumission et la disponibilité du dossier sur ClinicalTrials.gov (la première date publiée).
6 décembre 2017

Première soumission répondant aux critères de contrôle qualité

Première soumission répondant aux critères de contrôle qualité

La date à laquelle le promoteur de l'étude ou l'investigateur soumet pour la première fois un dossier d'étude conforme aux critères d'examen du contrôle qualité (CQ) de la National Library of Medicine (NLM). Le promoteur ou l'investigateur peut avoir besoin de réviser et de soumettre un dossier d'étude une ou plusieurs fois avant que les critères d'examen du CQ du NLM soient remplis. Il incombe au promoteur ou à l'investigateur de s'assurer que le dossier de l'étude est conforme aux critères d'examen du NLM QC.
6 décembre 2017

Première publication (Réel)

Première publication

La date à laquelle le dossier d'étude a été disponible pour la première fois sur ClinicalTrials.gov après la fin de l'examen du contrôle qualité (CQ) de la National Library of Medicine (NLM). Il y a généralement un délai de quelques jours entre la date à laquelle le promoteur de l'étude ou l'investigateur a soumis le dossier de l'étude et la première date de publication.
12 décembre 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

Dernière mise à jour publiée

La date la plus récente à laquelle les modifications apportées à un dossier d'étude ont été mises à disposition sur ClinicalTrials.gov. Il peut y avoir un délai entre le moment où les modifications ont été soumises à ClinicalTrials.gov par le promoteur ou l'investigateur de l'étude (la date de soumission de la dernière mise à jour) et la date de publication de la dernière mise à jour.
18 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

Dernière mise à jour soumise répondant aux critères de contrôle qualité

La date la plus récente à laquelle le promoteur de l'étude ou l'investigateur a soumis des modifications à un dossier d'étude qui sont conformes aux critères d'examen du contrôle qualité (CQ) de la National Library of Medicine (NLM). Il incombe au promoteur ou à l'investigateur de s'assurer que le dossier de l'étude est conforme aux critères d'examen du NLM QC.
24 avril 2026

Dernière vérification

Dernière vérification

La date la plus récente à laquelle le promoteur de l'étude ou l'investigateur a confirmé que les informations sur une étude clinique sur ClinicalTrials.gov étaient exactes et à jour. Si une étude avec un statut de recrutement de recrutement ; pas encore de recrutement ; ou actif, aucun recrutement n'a été confirmé au cours des 2 dernières années, le statut de recrutement de l'étude est indiqué comme inconnu.
1 avril 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

Autres numéros d'identification d'étude

Identifiants ou numéros d'identification autres que le numéro NCT qui sont attribués à une étude clinique par le sponsor de l'étude, les bailleurs de fonds ou autres. Ces numéros peuvent inclure des identifiants uniques d'autres registres d'essais et des numéros de subvention des National Institutes of Health.
  • 207735

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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