EUCTR2007-004223-38-DE进行中（未招募）1 期
A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients - Ofatumumab dose-finding in RRMS patients
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Genmab A/S
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. Patients with definite diagnosis of relapsing-remitting MS according to McDonald criteria
- •2. Patients with:
- •At least two documented relapses within the last 24 months or
- •At least one documented relapse within the last 12 months or
- •One documented relapse between 12 and 24 months prior to screening, and at least one documented T1 Gd-enhancing lesion on an MRI performed within 12 months prior to screening.
- •3. Patients with disability equivalent to Expanded Disability Status Scale (EDSS) score of 0-5.0 (both included) at screening
- •4. Neurologically stable patients with no evidence of relapse for at least 30 days prior to start of Screening and during the Screening Phase
- •5. Age 18-55 years
- •6. Female patients must be either post-menopausal, surgically incapable of bearing children, or practicing an acceptable method of birth control e.g. hormonal contraceptives, intrauterine device, spermicide and barrier as long as they are on trial medication and for a period of 1 year following the last infusion of trial drug. Females of childbearing potential must have a negative pregnancy test at screening visit prior to entry into the treatment period
- •7. Following receipt of verbal and written information about the trial, the patient must provide signed informed consent before any trial related activity is carried out.
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Diagnosis of SPMS, PPMS or PRMS or Neuromyelitis optica
- •2. Neurological findings consistent with PML or confirmed PML
- •3. Findings on brain MRI scan indicating any other clinically significant brain abnormality other than MS
- •4. Patients unable to undergo MRI scans (e.g. due to pacemaker, severe claustrophobia, hypersensitivity to contrast media) or who lack adequate peripheral venous access
- •5. Patients who have had the following treatments:
- •Lymphocyte-depleting therapies (e.g. alemtuzumab (Campath®), anti-CD4, cladribine, total body irradiation, bone marrow transplantation), mitoxantrone or cyclophosphamide at any time
- •Anti-CD20 treatments or any monoclonal antibodies at any time
- •Immunoglobulin, azathioprine, cyclosporine, tacrolimus or other immunosuppressive agents, immunomodulatory agents or plasma exchange within six months prior to randomization in the trial apart from Glatiramer Acetate and IFN-Beta
- •Glatiramer Acetate or IFN-Beta within three months prior to the randomization in the trial
- •Glucocorticoids or ACTH within one month prior to the screening in the trial
- •Receipt of a live vaccine within one month prior to screening in the trial
- •Plasmapheresis for treatment of relapses within 60 days prior to randomization in the trial
- •Initiation of therapy with Statins or hormone replacement treatment within one month or less prior to screening in the trial
- •Patients who have received other disease modifying therapies for MS may be allowed on a case to case basis after discussion with the medical officer at Genmab A/S
- •6. Past or current history of medically significant adverse effects (including allergic reactions) from:
- •Cetirizine
- •Prednisolone
- •Paracetamol/acetaminophen
- •Plasma proteins
- •or a known hypersensitivity to components of the investigational product
- •7. Past or current malignancy, except for
- •Cervical carcinoma Stage 1B or less
- •Non-invasive basal cell and squamous cell skin carcinoma
- •Cancer diagnoses with a complete response of a duration of > 5 years. Patients with a prior history of hematological malignancies are excluded regardless of response
- •8. Clinically significant cardiac disease, including acute myocardial infarction within six months from screening, unstable angina, congestive heart failure, previous venous or arterial thrombosis or arrhythmia requiring therapy
- •9. Electrocardiogram (ECG) showing significant abnormality that the treating investigator determines may jeopardize the subject’s health (i.e. acute ischemia, left bundle branch or bifascicular block)
- •10. Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, immunodeficiency syndrome, pulmonary, cerebral, psychiatric or neurological disease which may impair their reliable participation in the trial or necessitate the use of medication not allowed by this protocol
- •11. History of severe, clinically significant CNS trauma (e.g. cerebral contusion, spinal cord compression) or a history or presence of myelopathy due to spinal cord compression by disk or vertebral disease
- •12. Chronic or ongoing active infectious disease requiring systemic treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active Hep. C. Any previous serious infections should be discussed with the medical officer at Genmab A/S (e.g. opportunistic or atypical infections)
- •13. Female patients who are pregnant
研究者
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