2025-521591-64-00招募中3 期
RUBY study « Randomized controlled trial testing the efficacy of corticosteroid therapy versus placebo in fibrotic hypersensitivity pneumonitis.»
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 27
- 主要终点
- Absolute change in FVC (% pred) from baseline (inclusion visit, M0) to 6 months (M6) will be compared between the placebo arm and the prednisolone arm.
研究概览
简要总结
To assess the efficacy of first-line treatment with prednisolone against placebo, on the 6-month change in FVC in percent of predicted value (% pred).
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patient aged above 18 years and under 90 years old
- •Diagnosis of fibrotic HP (“definite” or “high confidence”) after MDD according to the criteria proposed by guidelines
- •Fibrosis extent ≥ 10% on chest HRCT
- •Mild to moderate functional impairment defined by FVC ≥ 50% pred and DLco ≥ 30% pred
- •Written informed consent for participation in study
- •Patient affiliated to a social security scheme or CMU beneficiary
- •Effective contraception for men and woman of childbearing age
排除标准
- •Uncertain diagnosis of fibrotic HP (“low confidence” or “unlikely”) after MDD according to the criteria proposed by guidelines
- •Severe functional impairment defined by FVC < 50% pred and DLco < 30% pred.
- •Patient previously treated or currently being treated for fibrotic HP (with corticosteroids, any immunosuppressive agent, or anti-fibrotic therapies).
- •Pregnant or breast-feeding woman.
- •Adults subject to a legal measure protection (guardianship, curatorship and safeguard of justice)
- •Contraindication to corticosteroid therapy (hypersensitivity to the active substances or to one of the excipients, severe infections, psychotic states not controlled by treatment, recent live vaccines administration, uncontrolled diabetes mellitus and uncontrolled arterial hypertension.) or to auxiliary medicinal products
- •Patient deprived of liberty under judicial or administrative decision
- •Patient participating in another clinical trial with an investigational medicinal product. The patient may participate in another clinical trial after the 6 months of treatment in this study
- •Patient receiving AME (state medical assistance)
结局指标
主要结局
Absolute change in FVC (% pred) from baseline (inclusion visit, M0) to 6 months (M6) will be compared between the placebo arm and the prednisolone arm.
Absolute change in FVC (% pred) from baseline (inclusion visit, M0) to 6 months (M6) will be compared between the placebo arm and the prednisolone arm.
次要结局
- The presence of a causal antigen will be assessed and reported by the investigator. Absolute change in FVC (% pred) from baseline (M0 or inclusion visit) to M6 according to the presence of a causal antigen.
- PFTs (spirometry and DLco) will be measured at M0, M3, M6 and M12. Absolute and relative changes in FVC (mL and %pred) between M0 and M12 will be compared between the placebo arm and the prednisolone arm. Absolute and relative changes in DLco (mmol/min/kPa and %pred) between M0, M6, and M12, will be compared between the placebo arm and the prednisolone arm.
- 6MWT will be carried out at M0, M6 and M12 by technicians and/or nurses trained in performing the test. Changes in distance walked during 6MWT (m and %pred) from M0 to M6 and M12 will be compared between the placebo arm and the prednisolone arm.
- Respiratory QoL will be measured at M0, M6 and M12 using the Saint Georges Hospital Respiratory Questionnaire (SGRQ) and King’s Brief ILD
- The proportion of patients who develop a phenotype of PPF within 12 months, as defined according to the ATS/ERS/JRS/ALAT guidelines, will be compared between the placebo arm and the prednisolone arm.
- The proportion of patients who receive a second-line treatment with corticosteroids, immunosuppressive or antifibrotic therapies within 12 months will be compared between the placebo arm and the prednisolone arm.
- The proportion of patients who require unplanned hospitalisation and/or develop an AE, as defined by Collard et al., within 12 months will be compared between the placebo arm and the prednisolone arm.
- PFS, defined by the first occurrence of one of the following events: relative decline in FVC ≥10 in % pred, first AE, lung transplant or death.
- Adverse events: the Common Terminology Criteria for Adverse Events will be used. The side-effects of corticosteroid therapy will be recorded at M3, M6 and M12. They will be assessed by looking for weight gain compared to M0, measuring blood pressure, collecting
研究者
Lucile SESE
Scientific
Assistance Publique Hopitaux De Paris
研究点 (27)
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