Aún no reclutaNCT07790198Registro de ClinicalTrials.gov

Tezepelumab CRSwNP Real World Study (CREW Study)

Chronic Rhinosinusitis With Nasal Polyps

Pregúntale a WCR sobre este estudio Registro oficial ↗

LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio: Observacional
Fase: No aplica / no indicada
Rango de edad: 18 años - No especificado
Sexo admitido: Todos los sexos
Voluntarios sanos: No aceptados
Participantes: 100 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

The CREW Study is a non-interventional prospective, observational study in patients with CRSwNP that will evaluate patient-reported outcomes and describe the proportion of participants achieving treatment goals.)

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

Participant must be 18 years of age or older, at the time of signing the informed consent
Confirmed diagnosis of CRSwNP for at least 12 months prior to routine care visit 1
Participants who will be enrolled after index date need to have at least SNOT-22 prior (maximum of 4 weeks) to index date
Documented SNOT-22 total score\>=30, collected within the 4 weeks prior to the first tezepelumab dose (index date)
Treated per the Japanese Handbook for the Management of Chronic Rhinosinusitis with Nasal Polyps for at least 30 days prior to routine care visit 1
Physician decision that participant is eligible for treatment with tezepelumab according to local approved CRSwNP label and Optimal Clinical Use Guidelines
Patients must be able and willing to read and comprehend written instructions, to collect PROs and medication intake and to sign the informed consent document

Exclusion Criteria:

Patients who participate in an interventional clinical trial in the last 4 months
Known hypersensitivity to tezepelumab or any of its excipients
Patients who have received any biologic therapy for asthma or CRSwNP
Condition (acute or chronic) that, in the investigator's opinion, would limit the participant´s ability to complete questionnaires or participate in this study
Pregnancy or lactation period or planning pregnancy during the study period

Población del estudio

The study population will consist of male and female participants aged ≥ 18 years with diagnosed severe uncontrolled CRSwNP, for whom a tezepelumab biologic treatment for CRSWNP will be initiated. Eligible participant will be identified in routine care and enrolled prospectively at participating sites.

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación: No informado
Enmascaramiento: No informado

Tezepelumab Treatment Group

Adult patients with severe CRSwNP who are newly initiated on subcutaneous (SC) tezepelumab. Eligible participants are those for whom therapy with systemic corticosteroids and/or surgery does not provide adequate disease control.

Drug: Tezepelumab

Tezepelumab DRUG

Subcutaneous (SC) tezepelumab indicated as add-on therapy for the treatment of participants with severe CRSwNP as part of routine clinical care.

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Mean change from baseline in sinonasal symptoms measured by SNOT-22 total score

Plazo: at 24 weeks from initiation of tezepelumab treatment.

To describe the changes in participant-reported sinonasal symptoms as evaluated by sinonasal outcome test, 22 item (SNOT-22) total score.

Medidas secundarias

Mean change from baseline in sinonasal symptoms measured by SNOT-22 total score

Plazo: at 4, 12, and 52 weeks from initiation of tezepelumab treatment

To describe the changes in participant-reported sinonasal symptoms as SNOT-22 total score following initiation of tezepelumab treatment.

Proportion of tezepelumab SNOT-22 responders

Plazo: up to 52 weeks

Proportion of responders in sinonasal symptoms as evaluated by SNOT-22 total score, defined as patients achieving the MCID (≥ 8.9-point decrease from baseline) at each collected timepoint.

Odds to achieve tezepelumab SNOT-22 response

Plazo: up to 52 weeks

Odds to achieve tezepelumab SNOT-22 response meeting or exceeding the MCID (≥ 8.9-point decrease from baseline) at each collected timepoint.

Median time to first MCID-defined responder in sinonasal symptoms

Plazo: up to 52 weeks

To describe time to response in sinonasal symptoms as evaluated by SNOT-22 total score (time from baseline to the first occurrence of ≥ 8.9-point decrease).

Mean change from baseline in nasal blockage (NB) measured by VAS-NB

Plazo: up to 52 weeks

To describe changes in nasal blockage (NB) as evaluated by a visual analogue scale (VAS-NB) at each collected timepoint.

Proportion of NB responders

Plazo: up to 52 weeks

To describe proportion of NB responders, defined as patients achieving the MCID (≥ 3.0-point decrease from baseline; in participants with VAS-NB ≥ 7 at baseline) at each collected timepoint.

Median time to meeting or exceeding the MCID for VAS-NB

Plazo: up to 52 weeks

Median time from baseline to the first occurrence of a ≥3.0-point decrease by each collected timepoint in participants with VAS-NB ≥ 7 at baseline.

Mean change from baseline in sense of smell score by VAS-smell

Plazo: up to 52 weeks

To describe changes in sense of smell as evaluated by VAS-Smell

Proportion of VAS-Smell responders

Plazo: up to 52 weeks

Proportion of VAS-Smell responders, defined as patients achieving the MCID (≥ 3.0-point decrease from baseline) in participants with VAS-Smell ≥ 7 at baseline at each collected timepoint.

Median time to meeting or exceeding the MCID for VAS-Smell

Plazo: up to 52 weeks

Median time from baseline to the first occurrence of a ≥3.0-point decrease by each collected timepoint in participants with VAS-Smell ≥ 7 at baseline.

Mean change from baseline in NP severity as measured by VAS-NP symptoms

Plazo: up to 52 weeks

To describe changes in NP severity (VAS-NP) at each collected timepoint.

Proportion of VAS-NP symptom responders

Plazo: up to 52 weeks

To describe responders proportion of VAS-NP symptom responders, defined as patients achieving the MCID (≥ 2.5-point decrease from baseline) at each collected timepoint.

Median time to meeting or exceeding the MCID for VAS-NP symptom

Plazo: up to 52 weeks

Median time from baseline to the first occurrence of a ≥2.5-point decrease by each collected timepoint.

Mean change from baseline in total NPS evaluated by nasal endoscopy

Plazo: up to 52 weeks

To describe changes in nasal polyp score (NPS) at each collected timepoint.

Proportion of NPS responders

Plazo: up to 52 weeks

To describe proportion of NPS responders, defined as patients achieving the MCID (≥ 1.0-point decrease from baseline).

Median time to meeting or exceeding the MCID for NPS

Plazo: up to 52 weeks

To describe median time to meeting or exceeding the MCID for NPS by each collected timepoint.

Proportion of participants who respond as 'well controlled' or 'completely controlled' NP symptoms to the NP control question

Plazo: up to 52 weeks

To describe responder proportion for NP control.

Median time to first attainment of NP well control or NP complete control

Plazo: up to 52 weeks

To describe median time to first attainment of NP well control or NP complete control by each collected timepoint.

Average SCS daily dose after initiating tezepelumab

Plazo: From baseline up to 24 weeks and from baseline up to 52 weeks

To describe overall systemic steroid use in participants, measured as average SCS daily dose (e.g., prednisone-equivalent milligrams).

Proportion of participants with CRSwNP-related, asthma-related and other-disease-related SCS use

Plazo: From baseline up to 24 weeks and from baseline up to 52 weeks

To describe proportion of participants with CRSwNP-related, asthma-related and other-disease-related SCS use.

Number of patients with ≥ 100, 200 and 400 mg cumulative SCS

Plazo: From baseline up to 24 weeks and from baseline up to 52 weeks

Number of patients with ≥ 100, 200 and 400 mg cumulative SCS (e.g., prednisone-equivalent milligrams).

Time-to-first disease-related SCS use

Plazo: From baseline up to 24 weeks and from baseline up to 52 weeks

Time-to-first disease-related SCS use, with cumulative incidence CRSwNP-related SCS use, asthma-related SCS use, other indications related SCS use and unknown indication-related SCS use.

Proportion of participants with AEs, SAEs, DAEs, and AESIs

Plazo: Up to 52 weeks

To describe the occurrence of adverse events in CRSwNP patients treated with tezepelumab.

Individual goal attainment