EUCTR2010-022378-15-ES进行中（未招募）不适用
VELVET (Veltuzumab various doses exploratory trial), a randomized, double blind, placebo controlled, multicentre, multinational phase II dose range finding trial in subjects with moderate to severe rheumatoid arthritis insufficiently controlled with either methotrexate alone or methotrexate plus anti-tumour necrosis factor biological treatment, comparing 3 different subcutaneous dosages of anti-CD20 monoclonal antibody veltuzumab to placebo as an add-on therapy to methotrexate. - VELVET
ycomed GmbH0 个研究点目标入组 300 人开始时间: 2011年2月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
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
- •- Written informed consent obtained before any trial-related activities
- •- Outpatient, male or female, at least 18 years of age at Screening
- •- Active rheumatoid arthritis. Diagnosis of RA using the ACR criteria for
- •the classification of RA for at least 6 months prior to trial entry (based
- •on swollen and tender joint count; CRP and/or ESR; RF and/or anti-CCP)
- •- An inadequate response to previous or current treatment with either
- •MTX alone or a combination of MTX plus anti-tumor necrosis factor alpha
- •biologic agents.
- •- Receiving MTX 15-25 mg/week (oral or parenteral) for at least 20
- •weeks, including the last 6 weeks prior to Baseline at a stable dose
- •- Subjects of reproductive potential (females and males) must agree to
- •use effective double-method contraception
- •- Female subjects must not be actively breast-feeding
- •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 210
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •Medical history/concurrent diseases
- •- Subjects who are wheel chair or bed bound
- •- Rheumatic autoimmune disease other than RA, or significant systemic
- •involvement secondary to RA
- •- History of or current inflammatory joint disease other than RA
- •- Septic prosthetic joint within the last 48 weeks prior to Baseline or
- •indefinitely if the prosthesis concerned remains in situ.
- •Infectious diseases
- •- Primary or secondary immunodeficiency, including human
- •immunodeficiency virus (HIV) infection
- •- Evidence of acute or chronic infection with hepatitis B virus (HBV) or
- •hepatitis C virus (HCV)
- •- Evidence and/or history of active tuberculosis (TB), prior to
- •successfully completing an anti-TB treatment. Subjects with latent TB
- •infection (LTBI) can be included
- •- Acute clinical manifestations of herpes zoster virus and history of
- •severe herpes zoster
- •- History of active infection of any kind or any major episode of infection
- •requiring hospitalisation or treatment with iv anti infective agents within
- •6 weeks prior to Baseline or oral anti-infective agents within 2 weeks
- •prior to Baseline
- •- History of deep space/tissue infection within 48 weeks prior to
- •- History of osteomyelitis
- •- History of sepsis of any origin requiring intensive care
- •- History of serious recurrent or chronic infections not specified above.
- •Cardio-pulmonary
- •- Any significant cardiac disease
- •- History of severe chronic obstructive pulmonary disease (COPD)
- •and/or history of severe COPD exacerbation(s) within the last 12
- •months prior to Screening .
- •Immune system/haematology/biochemistry
- •- History of a severe allergic reaction or anaphylactic reaction to a
- •biological agent or history of hypersensitivity to any component of
- •veltuzumab injection solution
- •- Subjects with CD4 cell counts (< 250/?l) at Screening
- •- Hypogammaglobulinemia (IgG < 5.0 g/L, and/or IgM < 0.20 g/L) at
- •- Splenectomy
- •- Subjects with haemoglobin < 9.0 g/dL, white blood cell (WBC) count <
- •3000 cells/?L, absolute neutrophil count (ANC) < 2000 cells/?L,
- •lymphocyte count < 800 cells/?L or platelet count < 100,000/?L at
- •- Aspartate aminotransferase (AST), alanine aminotransferase (ALT),
- •gamma-glutamyl transpeptidase (GGT) or alkaline phosphatase levels >
- •2.0 times the upper limit of normal (ULNR) at Screening
- •- Subjects with a serum creatinine > ULNR (e.g. > 1.2 mg/dL for males
- •and > 1.0 mg/dL for females) at Screening
- •Other medical conditions
- •- Subjects with diabetes mellitus type 1 or unstable type 2
- •- History of solid-organ transplantation
- •- History of cancer within the last 5 years treated with anti-cancer
- •chemotherapy
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研究者
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终止
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