EUCTR2007-004223-38-SE进行中（未招募）不适用
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
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 57
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 confirmed relapses within the last 24 months or
- •At least one confirmed relapse within the last 12 months or
- •One confirmed 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
- •Please refer to protocol for full list of exclusion criteria
- •1. Diagnosis of SPMS, PPMS or PRMS or Neuromyelitis optica
- •2. Neurological findings consistent with PML
- •3. Findings on brain MRI scan indicating any other clinically significant brain abnormality other than MS
- •4. Patients unable to undergo MRI scans
- •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 • Anti-CD20 treatments or any monoclonal antibodies
- •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
- •Glucocorticoids or ACTH within one month prior to the screening
- •Receipt of a live vaccine within one month prior to screening
- •Plasmapheresis for treatment of relapses within 2 months prior to randomization
- •Initiation of therapy with Statins or hormone replacement treatment within one month or less prior to screening
- •Patients who have received other disease modifying therapies for MS may be allowed on a case to case basis
- •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
- •10. Significant concurrent, uncontrolled medical condition
- •11. History of severe, clinically significant CNS trauma
- •12. Chronic or ongoing active infectious disease requiring systemic treatment
- •13. Female patients who are pregnant or nursing.
- •14. Use of an investigational drug or other experimental therapy for a condition other than MS within 4 weeks prior to screening. Any prior use of an investigational drug or other experimental therapy for MS at any time should be discussed
- •15. Current participation in any other interventional clinical study
- •16. Serum vitamin B12 below lower limit of normal
- •17. Positive PCR screening for JC Virus as measured by qualitative plasma and/or white blood cell JCV DNA
- •18. Serologic evidence of Hepatitis B (HB) infection based on the results of testing for HBsAg, anti-HBc and anti-HBs antibodies with eligibility based on the results as follows:
- •1. Patients positive for HBsAg are excluded
- •2. Patients negative for HBsAg but positive for both anti-HBc and anti-HBs antibodies (indicating past infection) are eligible
- •3. Patients negative for HBsAg and anti-HBc antibody but positive for anti-HB
- •antibody (indicating past vaccination) are eligible
- •4. Patients negative for HBsAg and anti-HBs antibody but positive for anti-HBc antibody will require clarification o
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