A Randomized Controlled Study of the Efficacy and Safety of Lenalidomide in the Treatment of Active IgG4-related Disease

Официальное название

A Randomized Controlled Study of the Efficacy and Safety of Lenalidomide in the Treatment of Active IgG4-RD

Обзор

For patients with active proliferative IgG4-RD, we plan to conduct a 52-week prospective randomized controlled trial to compare the efficacy and safety of 5mg lenalidomide plus prednisone, 10mg lenalidomide plus prednisone, and prednisone alone, so as to find new treatment measures for patients with proliferative IgG4-RD.

Вмешательства

• Препарат 5mg lenalidomide
  Lenalidomide 5mg/d combined with prednisone, prednisone at an initial dose of 0.6-0.8mg/kg/d for 2-4 weeks, then reduced by 5mg every 1-2 weeks until discontinued (within 24 weeks)
• Препарат 10mg lenalidomide
  Lenalidomide 10mg/ day combined with prednisone, prednisone at an initial dose of 0.6-0.8mg/kg/ day for 2-4 weeks, then reduced by 5mg every 1-2 weeks until discontinued (within 24 weeks)
• Препарат Prednisone monotherapy
  The initial dose of prednisone was 0.6-0.8mg/kg/ day for 2-4 weeks, followed by 5mg every 1-2 weeks until withdrawal (within 24 weeks).

Первичные конечные точки

• Recurrence rate at 52 weeks [Срок оценки: "From enrollment to the end of treatment at 52 weeks]

Вторичные конечные точки (6)

• Treatment response rate [Срок оценки: At 4, 12, 24, 36, 52 weeks]
• IgG4 - RD RI change [Срок оценки: At 4, 12, 24, 36, 52 weeks]
• Change of IgG4-RD damage index (DI) [Срок оценки: At 4, 12, 24, 36, 52 weeks]
• physician's overall assessment of disease activity [Срок оценки: At 4, 12, 24, 36, 52 weeks]
• Changes of serum IgG4 levels [Срок оценки: At 4, 12, 24, 36, 52 weeks]
• security [Срок оценки: At 4, 12, 24, 36, 52 weeks]

Критерии участия

Критерии включения

• Patients aged between 18 and 75 years who meet the 2019 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for IgG4-RD；
• Patients with active disease: For patients with initial treatment or relapse after drug withdrawal, active disease is defined as having an IgG4-RD Response Index (RI) of at least 2 points in at least one organ at the time of screening; for those experiencing relapse while on treatment, active disease is defined as having an IgG4-RD RI of at least 3 points in at least one organ at the time of screening；
• Patients with the clinical subtype of proliferative IgG4-RD；
• Patients who have no plans for pregnancy within the next 18 months and who agree to use reliable contraceptive measures during the study period；

Критерии исключения

• IgG4-RD patients with only fibrotic features;
• Absolute neutrophil count <1.5×10\^9 /L or platelet count <100×10\^9/L;
• Creatinine clearance less than 60 ml/ min;
• Liver function Child-Pugh grade B or above;
• Chronic active infection requiring systemic treatment;
• Diagnosed with malignant tumor in the past five years;
• Patients with a history of thrombosis;
• Using biological agents within six months;
• Known to be allergic to lenalidomide or thalidomide;
• Pregnant or lactating women;
• Patients with any other medical conditions or for specific reasons judged by the investigator to be ineligible to participate in the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking Union Medical College Hospital, Beijing, Beijing 100050 — Пекин

Идентификаторы

NCT: NCT07068165 · I-25PJ0175

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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