NCT07399665
招募中
不适用
Open-label Single-arm, Non-interventional, Multi-centre Study for Evaluation of Clinical and Patient Reported Outcomes in Adult Patients With CRSwNP on Tezepelumab
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 110
- 试验地点
- 11
- 主要终点
- 1. Change in endoscopic status of CRSwNP based on NPS
概览
简要总结
ARES is a multi-centre, retrospective-prospective, non-comparative and non-interventional (observational) cohort study involving primary and secondary data collection within real-world settings of participants who have initiated tezepelumab (no more than 4 weeks before inclusion) for treatment of CRSwNP (with or without comorbid asthma).
详细描述
ARES is a multi-centre, retrospective-prospective, non-comparative and non-interventional (observational) cohort study involving primary and secondary data collection within real-world settings of participants who have initiated tezepelumab (no more than 4 weeks before inclusion) for treatment of CRSwNP (with or without comorbid asthma) to capture real-world data on the effectiveness and use patterns of tezepelumab outside the controlled conditions of a randomized clinical trial.
The study will be conducted in real-world setting at approximately 10 sites in the Russian Federation. A total of 110 eligible adult participants (aged ≥18 years) of both sexes who will be treated with tezepelumab as prescribed by their treating physicians will be enrolled.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants aged 18 years or older at the time of signing the ICF.
- •Diagnosis of CRSwNP established for at least 52 weeks prior to tezepelumab initiation.
- •Availability of participants' medical records for at least 52 weeks prior to tezepelumab initiation, including history of sCS use / nasal polyps surgery (or information about contraindications / intolerance to).
- •Prescribed and initiated treatment with tezepelumab according to SmPC and local market reimbursement criteria. A period between treatment initiation and enrolment should be no more than 4 weeks.
- •The severity of CRSwNP consistent with need for surgery as defined by total NPS ≥ 5 (at least 2 for each nostril) at the enrollment.
- •Nasal Blockage score as part of SNOT-22 (NBS-SNOT-22) ≥ 3 at the enrollment.
- •SNOT-22 total score ≥ 30 at enrollment or up to 12 weeks before enrollment.
- •Currently receive care from specialist physicians (e.g., otolaryngologist) at the Investigator's or sub-Investigator's site.
- •Provision of signed and dated written informed consent.
- •Participants are able to read, understand and complete the questionnaires required by the protocol.
排除标准
- •Any contraindication to tezepelumab as per the approved product SmPC in Russia or in the opinion of the Investigator.
- •Administration of concurrent biologic drug for CRSwNP / asthma since the index date, except for stable allergen immunotherapy (defined as a stable dose and regimen at the time of enrolment). Enrolment of patients who were switched from other biologic(s) to tezepelumab is allowed, and an acceptable timeframe since the last prior biologic drug is ≥ 60 days. The number of participants with prior biologic treatment (switching to tezepelumab) should be targeted at 20% or less.
- •Participation in an observational study that might, in the Investigator's opinion, influence the assessment for the current study, or participation in an interventional clinical trial in the last 3 months.
- •Pregnancy or lactation period.
结局指标
主要结局
1. Change in endoscopic status of CRSwNP based on NPS
时间窗: time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation
Change in NPS score from baseline
2. Change in a nasal congestion status based on Nasal Blockage score as part of SNOT-22 (NBS-SNOT-22)
时间窗: time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation
Change in Nasal blockage score as part of SNOT-22 (NBS-SNOT-22) from baseline
3. Change in endoscopic status of CRSwNP based on NPS
时间窗: time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation
Proportion of patients with at least a 1-point improvement in NPS score from baseline
4. Change in a nasal congestion status based on Nasal Blockage score as part of SNOT-22 (NBS-SNOT-22)
时间窗: time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation
Proportion of patients with at least a 1-point improvement in Nasal blockage score as part of SNOT-22 (NBS-SNOT-22) from baseline
次要结局
- 7. Proportion of participants with ACQ-5 response (reduction of ≥ 0.5 in score from baseline)(time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation)
- 1. Change in SNOT-22 total score from baseline(time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation)
- 18. Proportion of participants with 0, 1, 2, ≥3 CRSwNP exacerbations(time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation)
- 2. Proportion of participants with clinically meaningful change (reduction in SNOT-22 score by ≥ 8.9) from baseline(To describe the participant-reported evaluation of the symptoms of CRSwNP using the Sinonasal Outcome Test-22 (SNOT-22) at baseline* and up to 52 weeks following tezepelumab initiation.)
- 3. Change in loss of smell (as a part of SNOT-22) from baseline(time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation)
- 4. Proportion of patients with at least a 1-point change in loss of smell (as a part of SNOT-22) from baseline(time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation)
- 5. Change in Lund-Mackay score from baseline(time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation)
- 6. Change in ACQ-5 score from baseline(time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation)
- 8. Number (proportion) of participants with CRSwNP-related healthcare resource utilisation (by each type)(time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation)
- 9. Annualised rates of CRSwNP-related hospitalisation, emergency calls (or emergency department visits), and unscheduled out-patient visits to a physician(time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation)
- 10. Annualised rates of CRSwNP-related scheduled physician visits or healthcare calls for CRSwNP(time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation)
- 11. Median overall duration (days) of CRSwNP-related hospitalisations(time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation)
- 12. Number (proportion) of participants with asthma-related healthcare resource utilisation (by each type)(time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation)
- 13. Annualised rates of asthma-related hospitalisation, emergency calls (or emergency department visits), and unscheduled out-patient visits to a physician(time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation)
- 14. Annualised rates of asthma-related scheduled physician visits or healthcare calls for asthma(time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation)
- 15. • Median overall duration (days) of asthma-related hospitalisations(time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation)
- 16. Annualised rate of CRSwNP exacerbations(time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation)
- 17. Change in annualised rate of CRSwNP exacerbations from the baseline period to the follow-up period after tezepelumab initiation(time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation)
- 19. Cumulative days of CRSwNP exacerbations (calculated in participants who had CRSwNP exacerbations at baseline)(time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation)
- 20. Annualised rate of severe* asthma exacerbations(time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation)
- 21. Change in annualised rate of severe* asthma exacerbations from the baseline period to the follow-up period after tezepelumab initiation(time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation)
- 22. Proportion of participants with 0, 1, 2, ≥3 severe* asthma exacerbations(time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation)
- 23. Cumulative days of severe* asthma exacerbations (calculated in participants who had asthma exacerbations at baseline)(time points to measure: during 52 weeks before tezepelumab initiation and up to 52 weeks following tezepelumab initiation)
- 24. Median duration (days) of treatment with tezepelumab (to be calculated in all enrolled participants)(time points to measure: Week 52/End of Study)
- 25. Proportion of participants with tezepelumab discontinuation overall and by reason(time points to measure: Week 52/End of Study)
- 26. • Median time (days) to tezepelumab discontinuation (to be calculated in participants who discontinued tezepelumab earlier than Week 52 by any reason)(time points to measure: Week 52/End of Study)
- 27. Proportion of participants discontinued tezepelumab and switched to other biologic drug for CRSwNP / asthma treatment and reason(s)(time points to measure: Week 52/End of Study)
- 28. Change in blood eosinophils level (cells/μL) from baseline(time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation)
- 29. Change in total IgE level (IU/mL) from baseline(time points to measure: baseline and at Weeks 4, 24 and 52 following tezepelumab initiation)
- 30. Mean duration (days) of treatment with tezepelumab (to be calculated in all enrolled participants)(time points to measure: Week 52/End of Study)
- 31. Proportion of participants discontinued tezepelumab and switched to other biologic drug for CRSwNP / asthma treatment and reason(s)(time points to measure: Week 52/End of Study)
研究者
研究点 (11)
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