Assessment of the Handling Experience With the BI 695501 Autoinjector in Patients With Rheumatoid Arthritis Followed by an Extension Phase Using BI 695501 Prefilled Syringe
Assessment of Real-life Patient Handling Experience of BI 695501 Administered Subcutaneously With an Autoinjector in Patients With Rheumatoid Arthritis: an Open-label, Interventional Clinical Trial Followed by an Extension Phase of BI 695501 Administered With a Prefilled Syringe
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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California
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Upland, California, Estados Unidos, 91786
- Inland Rheumatology Clinical Trials, Inc.
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Florida
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Venice, Florida, Estados Unidos, 34292
- Lovelace Scientific Resources, Incorporated
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Maryland
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Cumberland, Maryland, Estados Unidos, 21502
- Klein and Associates, M.D., P.A.
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Massachusetts
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Worcester, Massachusetts, Estados Unidos, 01605
- Clinical Pharmacology Study Group
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87102
- Albuquerque Center For Rheumatology
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Texas
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Dallas, Texas, Estados Unidos, 75231
- Metroplex Clinical Research Center
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Houston, Texas, Estados Unidos, 77065
- Rheumatology Clinic of Houston, P.A.
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Lubbock, Texas, Estados Unidos, 79424
- Arthritis & Osteoporosis Associates LLP
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Nassau Bay, Texas, Estados Unidos, 77058
- Heartland Research Associates, LLC
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Bialystok, Polônia, 15-099
- Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
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Bydgoszcz, Polônia, 85-168
- Szpital Uniwersytecki nr 2 im.dr J. Biziela
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Elblag, Polônia, 82-300
- Wojewodzki Szpital Zespolony w Elblagu
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Gdynia, Polônia, 81-338
- Medica Pro Familia Spolka Akcyjna, Oddzial w Gdyni
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Katowice, Polônia, 40-954
- Medical Centre Pratia Katowice I
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Krakow, Polônia, 30-002
- Medical Centre Pratia Krakow
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Krakow, Polônia, 31-023
- Specialist Center ALL-MED, Krakow
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Torun, Polônia, 87-100
- Niepubliczny ZOZ, "Nasz Lekarz", Lekarzy Rodzinnych z
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Warszawa, Polônia, 01-868
- Medical Centre Pratia Warszawa
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Wroclaw, Polônia, 51-128
- Wojewodzki Szpital Specjalistyczny We Wroclawiu
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion criteria:
- Moderately to severely active Rheumatoid arthritis (RA) for at least 6 months, which is not adequately controlled by non-biologics DMARDs.
- No contraindications to anti-Tumor necrosis factor (TNF) agents.
- Either biologics naive or biologics-experienced but with no experience of self-administration medication using autoinjector or pen.
- Patients must be able and willing to self-inject BI 695501. Further inclusion criteria apply.
Exclusion criteria:
- Experience with self-administration of medication using an autoinjector or pen.
- American College of Rheumatology functional Class IV or wheelchair/ bed bound.
- Primary or secondary immunodeficiency.
- History of tuberculosis (TB). Further exclusion criteria apply.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: BI 695501
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Autoinjector Assessment Period: Percentage of Successful Self-injections as Reported in the Questionnaires Completed by Both the Trial Site Personnel and the Patient Analysing All Self-injections
Prazo: Up to Day 50.
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The percentage of successful self-injections as reported in the questionnaires completed by both the trial site personnel and the patient during the Autoinjector Assessment Period analyzing all self-injections occurring after the training self-injection up to the EoT Visit. Successful self-injections were based on the response to Question 2 (Q2) on the questionnaire, which queried whether the full content of the autoinjector was injected into the body. An injection was considered successful when both the patient and the qualified trial site personnel responded yes to the Q2 on their respective questionnaires. If they responded no to Q2, patients and trial site personnel were instructed to also answer Question 3, which asked what prevented the patient for injecting the full contents of the autoinjector. Planned injections after discontinuation from the trial were not included in the analysis. Percentage of injections calculated relative to the total number of first injections. |
Up to Day 50.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Autoinjector Assessment Period: Percentage of Any Autoinjector Handling Events
Prazo: Up to Day 50.
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The percentage of any autoinjector handling event during the self-injection process included any one of the following events which prevented the patient from successfully self-injecting the full content of the autoinjector and which occurred after the training self-injection up to the EoT Visit: removing the cap of the autoinjector (3a); pressing the injection button of the autoinjector (3b); or holding the autoinjector down against the skin until the injection is completed (3c). Percentage of injections was calculated relative to the total number of injections (both unsuccessful and successful). |
Up to Day 50.
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Autoinjector Assessment Period: The Percentage of Patients With Local Injection Site Reactions
Prazo: Up to 17 weeks.
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Qualified trial site personnel contacted the patient 48 hours after each self-injection during the autoinjector assessment period to collect all Adverse Events (AEs), including injection-site reactions. Data is reported as Treatment-Emergent AEs (TEAEs), defined as AEs that started or worsened on or after the first dose of trial medication during the treatment period and prior to the last date of trial medication during treatment period + 10 weeks (70 days) inclusive. The autoinjector assessment period started on the first autoinjector administration date (Day 1 visit) and ended on Day 50 visit date (included). If a TEAE occurred in the 10 weeks after the last autoinjector administration but prior to the first injection during the extension phase, it was to be accounted for in the autoinjector assessment period. Percentage of subjects calculated relative to the total number of subjects in the analysis set. |
Up to 17 weeks.
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Autoinjector Assessment Period: The Percentage of Patients With Drug-related Adverse Events Per Investigator Assessment
Prazo: Up to 17 weeks.
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A treatment-related TEAE was defined as any TEAE assessed by the investigator as related to the trial medication.
Data is reported for the autoinjector assessment period.
TEAEs were defined as AEs that started or worsened on or after the first dose of trial medication during the treatment period and prior to the last date of trial medication during treatment period + 10 weeks (70 days) inclusive.
The autoinjector assessment period started on the first autoinjector administration date (Day 1 visit) and ended on Day 50 visit date (included).
If a TEAE occurred in the 10 weeks after the last autoinjector administration but prior to the first injection during the extension phase, it was to be accounted for in the autoinjector assessment period.
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Up to 17 weeks.
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Autoinjector Assessment Period and Extension Phase: The Percentage of Patients With Local Injection Site Reactions
Prazo: up to Week 60
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The percentage of patients with local injection site reactions in the Autoinjector assessment period and Extension Phase.
In Extension phase, patients were given diaries to record events between each site visit during extension phase.
Patients were instructed to accurately record the following on the diary cards: the dates & times of BI 695501 dosing; problems encountered with dosing; the occurrence of any AEs; the use of concomitant therapies; and the PFS storage conditions.
Patients were instructed to contact the site if they experienced any AEs between designated site visits.
In Extension phase Data is reported as Treatment-Emergent AEs (TEAEs), defined as AEs that started or worsened on or after the first PFS administration date (Day 57 visit) and after the 10 weeks of the last dose during the extension phase, it was to be accounted for in the Extension phase treatment period.
Percentage of subjects calculated relative to the total number of subjects in the analysis set
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up to Week 60
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Autoinjector Assessment Period and Extension Phase: The Percentage of Patients With Drug-related Adverse Events as Per Investigator Assessment
Prazo: up to Week 60
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The percentage of patients with drug-related adverse events as per investigator in the Autoinjector assessment period and Extension Phase.
In Extension phase, Treatment-Emergent AEs (TEAEs), defined as AEs that started or worsened on or after the first dose of trial medication and prior to the last date of trial medication during Extension phase treatment period + 10 weeks (70 days) inclusive.
The Extension phase treatment period started on the first PFS administration date (Day 57 visit) and ended on Day 351 visit date (included).
Thus If a TEAE occurred from the first PFS administration and after the 10 weeks of the last dose during the extension phase, it was to be accounted for in the Extension phase treatment period.
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up to Week 60
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 1297.11
- 2015-003030-27 (Número EudraCT)
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