EUCTR2004-002567-24-HU进行中（未招募）不适用
A Phase 2a Magnetic Resonance Imaging Study of the Safety and Efficacy of MLN1202 in patients with Multiple Sclerosis - Not applicable
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 160
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
- •Each patient must meet all of the following inclusion criteria to be enrolled in the pre-treatment phase of the study:
- •Be 18 years of age or older
- •Have a diagnosis of RRMS
- •Have had at least 1 documented relapse of MS within 18 months prior to study entry
- •Have an Expanded Disability Status Score (EDSS) of 0 to 5.5, inclusive (see Study Manual for calculation details)
- •Be willing and able to comply with the protocol for the duration of the study period
- •Be willing to use adequate double-barrier” contraceptive methods for the duration of the study period
- •If female, must be neither pregnant nor breast-feeding. Confirmation that the patient is not pregnant must be established by a negative serum hCG pregnancy test within 7 days of study entry and again within 7 days prior to the first administration of study drug.
- •Have given written informed consent prior to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care
- •Each patient must meet the following inclusion criteria to be enrolled in the treatment phase of the study:
- •Have a total of at least 2 new Gd-enhancing lesions seen over the series of 3 pre-treatment MRIs. (Note: If a patient experiences a flare of disease during the pre-treatment period requiring the use of corticosteriods according to the exclusion criteria below, MRIs will not be performed for 2 months after completion of corticosteroids, at which time pre-screening monthly MRIs will then continue until the patient has completed 3 scans. The patient’s schedule of visits will be adjusted accordingly. The use of corticosteroids during the pre-treatment period will be limited to a 3 to 5 day course of IV methylprednisolone without subsequent oral corticosteroids.)
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
- •Have a diagnosis of PPMS or SPMS
- •Have received any investigational drug or experimental procedure within 3 months prior to Study Day 0
- •If the patient has received disease-modifying cyclophosphamide (Cytoxan®) or mitoxantrone [Novantrone®] for MS, that treatment must have discontinued 6 months prior to study Day 0.
- •If the patient has received the following prior disease modifying treatments: (interferons [Avonex®, Rebif®, Betaseron/®Betaferon®], glatiramer acetate [Copaxone®], azathioprine [Imuran®]) for MS, that treatment must have discontinued at least 12 weeks prior to study Day 0.
- •If the patient has received disease-modifying methotrexate, IV immunoglobulin, cyclosporin, or plasma exchange for MS, that treatment must have discontinued at least 8 weeks prior to study Day 0.
- •If the patient has received prior treatment with corticosteroids for MS, the patient must have discontinued that treatment at least 8 weeks prior to Study Day 0.
- •If the patient has ever been exposed to Tysabri® (natalizumab) or any other VLA-4 (a4b1) antagonist.
- •Have an active infection or be considered to be at high risk for developing an infection, including reactivation of latent tuberculosis, in the opinion of the investigator.
- •Have a history of hepatitis B, C, or human immunodeficiency virus (HIV)
- •Have a chest X-ray within 6 months of Study Day 0 with clinically significant findings or abnormalities, in the opinion of the investigator
- •Have inadequate renal (serum creatinine >1.5 times the upper limit of normal [ULN]) or hepatic function (aspartate transaminase [AST] or alanine transaminase [ALT] >2 times the ULN)
- •Have a known history of cancer, except for distant history (>10 years) of carcinoma in situ of the cervix or adequately treated basal cell carcinoma of the skin
- •Received any live, attenuated vaccinations within 30 days prior to Study Day 0
- •Have a history of illicit drug or alcohol abuse within 5 years of Study Day 0
- •Have a history of hypersensitivity to prior mAb treatment
- •Have a history of allergy or sensitivity to Gd
- •Have a history that would preclude serial MRI scans (eg, known implanted devices, claustrophobia, chronic low back pain, involuntary movements, poor venous access)
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