EUCTR2008-000972-25-AT进行中（未招募）1 期
A 24-week with possible extension, prospective, multicentre, randomized,double blind, placebo-controlled, 2-parallel group with a randomization1:1, Phase 3 study to compare efficacy and safety of masitinib at 6mg/kg/day to placebo in treatment of patients with Smouldering Systemic,Indolent Systemic or Cutaneous Mastocytosis with handicap.
AB Science0 个研究点目标入组 223 人开始时间: 2010年9月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 223
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patient with one of the following documented mastocytosis as per WHO classification:
- •Smouldering Systemic Mastocytosis
- •Indolent Systemic Mastocytosis
- •2. Patient with documented mastocytosis and evaluable disease based upon histological criteria: typical
- •infiltrates of mast cells in a multifocal or diffuse pattern in skin and/or bone marrow biopsy
- •3. Patient with documented treatment failure of his/her handicap(s) with at least one of the following therapy
- •used at optimized dose (refer to table 2):
- •Proton pump inhibitor
- •Osteoclast inhibitor
- •Cromoglycate Sodium
- •Antileukotriene
- •4. Handicapped status defined as at least two of the following handicaps, including at least one among pruritus,
- •flushes, depression and fatigue:
- •Pruritus score = 9
- •Number of flushes per week = 8
- •Hamilton rating scale for depression(HAMD-17) score = 19
- •Number of stools per day = 4
- •Number of micturition per day = 8
- •Fatigue Impact Scale total score (asthenia) = 75
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 75
排除标准
- •1. Patient with one of the following mastocytosis:
- •Cutaneous Mastocytosis
- •Not documented Smouldering Systemic Mastocytosis or Indolent Systemic Mastocytosis
- •Systemic Mastocytosis with an Associated clonal Hematologic Non Mast cell lineage Disease (SMAHNMD)
- •Mast cell leukaemia (MCL)
- •Aggressive systemic mastocytosis (ASM)
- •2. Previous treatment with any Tyrosine Kinase Inhibitor
研究者
相似试验
进行中（未招募）
不适用
Comparison of efficacy of masitinib versus methotrexate in the treatment of rheumatoid arthritisMedDRA version: 17.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersRheumatoid ArthritisEUCTR2010-020992-21-DEAB Science140
进行中（未招募）
1 期
A 24-week with possible extension, prospective, multicentre, randomized, double blind, placebo-controlled, 2-parallel group with a randomization 1:1, Phase III study to compare efficacy and safety of masitinib at 6 mg/kg/day to placebo in treatment of patients with Smouldering Systemic, Indolent Systemic or Cutaneous Mastocytosis with handicapSmouldering Systemic, Indolent Systemic or Cutaneous Mastocytosis with handicapsMedDRA version: 9.1 Level: LLT Classification code 10026891 Term: MastocytosisEUCTR2008-000972-25-FRAB SCIENCE200
进行中（未招募）
1 期
A 24-week with possible extension study to compare efficacy and safety of masitinib to placebo in treatment of patients with Smouldering or Indolent Severe Systemic mastocytosisSmouldering or Indolent Severe Systemic mastocytosisEUCTR2016-001447-39-FRAB SCIENCE140
进行中（未招募）
1 期
A 24-week with possible extension, prospective, multicentre, randomized, double blind, placebo-controlled, 2-parallel group with a randomization 1:1, Phase III study to compare efficacy and safety of masitinib at 6 mg/kg/day to placebo in treatment of patients with Smouldering Systemic, Indolent Systemic or Cutaneous Mastocytosis with handicapSmouldering Systemic, Indolent Systemic or Cutaneous Mastocytosis with handicapsMedDRA version: 9.1Level: LLTClassification code 10026891Term: MastocytosisEUCTR2008-000972-25-BGAB SCIENCE223
进行中（未招募）
1 期
Study to compare efficacy and safety of masitinib at 6 mg/kg/day toplacebo in treatment of patients with Systemic mastocytosis with severe handicapSmouldering Systemic or Indolent Systemic Mastocytosis with handicap.MedDRA version: 17.0Level: PTClassification code 10026891Term: MastocytosisSystem Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2008-000972-25-GRAB Science150