2023-503226-39-00招募中2 期
Study of immunological activity after personalized immunomodulatory therapy regulating the Th17 pathway in patients with extramembranous glomerulonephritis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Intraindividual variation in anti-PLA2R1 antibody titer (ELISA titer in RU/mL), after 6 months of IFNα (Pegasys®) treatment compared to pre-treatment antibody titer
研究概览
简要总结
To measure the immunological activity of GEM with anti-PLA2R1 antibodies in immunologically relapsed patients with a Th17-like cytokine profile before and after 6 months of personalized IFNα (Pegasys®) therapy.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Subjects 18 years or older
- •GEM with anti-PLA2R1 autoantibody
- •Immunological relapse (defined by an increase in anti-PLA2R1 antibody titre > 14 RU/mL after a negative phase of anti-PLA2R1 antibodies, that is, immunological remission)
- •IL-17A plasma levels > 73 pg/mL after non-specific stimulation of peripheral blood immune cells
- •Symptomatic antiprotein treatment with stable and maximum tolerated dosage
- •Patients with a biological workup at the screening visit with (i) a platelet count≥ 90,000 cells/mm3; (ii) a neutrophil count ≥ 1500 cells/mm3; and (iii) appropriately monitored normal thyroid function (TSH and T4)
排除标准
- •Immunosuppressive treatment for GEM within 6 months prior to the screening visit
- •Cancer under treatment
- •Pre-existing retinopathies
- •Active and severe infections
- •Severe liver failure or cirrhosis
- •Pregnancy or breastfeeding
- •Pre-existing severe heart failure
- •Pre-existing psychiatric disorder or patient likely to be anxious or depressed (HAD score > 11)
- •Patients using substances or abusing substances
- •Hypersensitivity to the active substance or excipients of the study treatment
- •Secondary GEM (associated with cancer, infectious disease, autoimmune or iatrogenic disease)
- •Active nephrotic syndrome defined by KDIGO guidelines as proteinuria > 3.5 g/day (or 3.5 g/g on urine sample) and albumin < 30 g/L
- •Absence of immunological (anti-PLA2R1 antibody < 14 RU/mL in ELISA or negative indirect immunofluorescence) and clinical (partial or complete) remission
- •Patients with a history of thrombosis or on anticoagulant therapy
结局指标
主要结局
Intraindividual variation in anti-PLA2R1 antibody titer (ELISA titer in RU/mL), after 6 months of IFNα (Pegasys®) treatment compared to pre-treatment antibody titer
Intraindividual variation in anti-PLA2R1 antibody titer (ELISA titer in RU/mL), after 6 months of IFNα (Pegasys®) treatment compared to pre-treatment antibody titer
次要结局
- Intraindividual variation in proteinuria and albumin levels under IFNα (Pegasys®) treatment and stable symptomatic treatment
- Intraindividual variation in cytokine profile (assay of 9 cytokines: IL-12p70; IL-17A; IL-4; IL-5; IL-1β; IL-10; IFNα; IL-6 and IFNγ) before and after 6 months of personalized treatment with IFNα (Pegasys®)
- Clinical and Biological Tolerance of IFNα Therapy (Pegasys®)
- Description of an effective IFNα (Pegasys®) regimen (one or two monthly doses) to induce an IL-17A level below 73 pg/ml
研究者
TEISSEYRE Maxime
Scientific
Centre Hospitalier Universitaire De Nice
研究点 (1)
Loading locations...
相似试验
招募中
2 期
Trial assessing fianlimab plus cemiplimab plus chemotherapy or cemiplimab plus chemotherapy in patients with pleural mesotheliomaPleural mesothelioma2024-519208-29-00Intergroupe Francophone De Cancerologie Thoracique126
撤回
1 期
KISIMA-02 vaccine-based immunotherapy for patients with mutated pancreatic cancer2022-501854-12-00Amal Therapeutics S.A.15
招募中
3 期
The Nordic Chronic Migraine Trial of CGRP monoclonal antibody and onabotulinumtoxin A dual therapy – a randomized-controlled double-blind trial (NorMig)2024-517981-40-00Oslo University Hospital HF450
进行中（未招募）
1 期
A Phase I/II, Dose-finding Study to Assess the Safety, Reactogenicity, and Immunogenicity of a Broadly Protective Sarbecovirus Vaccine (GBP511) in Healthy Adults.NCT07280858SK Bioscience Co., Ltd.368
招募中
4 期
REDUCE PMR: Rituximab Effect on Decreasing glUcoCorticoid Exposition in relapsing PolyMyalgia RheumaticaPolymyalgia rheumatica2024-513545-37-00Sint Maartenskliniek Stichting174