EUCTR2007-001161-14-FR进行中（未招募）1 期
A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Scleroris. - CARE MS-I
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 525
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
- •Signed, informed consent form
- •Age 18 to 50 years old (inclusive) as of signing informed consent form (ICF)
- •Diagnosis of MS per update of McDonald criteria, and cranial MRI scan demonstrating white matter lesions attributable to MS within 5 years prior to screening
- •Onset of MS symptoms (as determined by a neurologist) within 5 years prior to screening
- •EDSS score 0.0 to 3.0 (inclusive)
- •>/= 2 MS attacks (first episode or relapse) occurring in the 24 months prior to screening, with >/= 1 attack prior to screening, with objective neurological signs confirmed by a physician
- •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
- •Received prior therapy for MS other than corticosteroids, eg, interferons, IV immunoglobulin, glatiramer acetate, natalizumab, and mitoxantrone
- •Exposure to azathioprine, cladiribine, cyclophosphamide, cyclosporine A, methotrexate, or any other immunosuppressive agent other than systemic corticosteroid treatment
- •Received treatment with a monoclonal antibody for any reason
- •Has any progressive form of MS
- •History of malignancy (except for basal cell skin carcinoma if disease-free for >/=5 years)
- •Any disability acquired from trauma or another illness that, in the opinion of the Investigator, could interfere with evaluation of disability due to MS
- •Previous hypersensitivity reaction to other immunoglobulin product
- •Known allergy or intolerance to interferon beta, human albumin, or mannitol
- •Intolerance of pulsed corticosteroids, especially a history of steroid psychosis
- •Inability to self-administer SC injections or receive SC injections from caregiver
- •Inability to undergo MRI with gadolinium administration
- •Documented CD4+ cell count <490/mm3 within the past year
- •Documented CD8+ cell count <200/mm3 within the past year
- •Seropositivity for human immunodeficiency virus (HIV)
- •Significant autoimmune disease (eg, immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders; vasculitis; inflammatory bowel disease; severe psoriasis)
- •Presence of anti-thyroid stimulating hormone (TSH) receptor (TSHR) antibodies
- •Active infection, eg, deep-tissue infection, that the Investigator considers sufficiently serious to preclude study participation
- •Latent tuberculosis unless effective anti-tuberculosis therapy has been completed, or active tuberculosis
- •Infection with hepatitis B virus or hepatitis C virus
- •Of childbearing potential with a positive serum pregnancy test
- •Unwilling to agree to use a reliable and acceptable contraceptive method throughout the study period (fertile patients only); reliable and effective contraceptive method(s) include: condoms (male or female) with or without a spermicidal agent, diaphragm with spermicide or cervical cap, intrauterine device [IUD], or hormonal-based contraception
- •Major psychiatric disorder that is not adequately controlled by treatment
- •Epileptic seizures that are not adequately controlled by treatment
- •Major systemic disease or other illness that would, in the opinion of the Investigator, compromise patient safety or interfere with the interpretation of study results
- •Current participation in another clinical study
- •Medical, psychiatric, cognitive, or other conditions that, in the Investigator’s opinion, compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study
- •Confirmed platelet count < the lower limit of normal (LLN) of the evaluating laboratory at Screening or documented at <100,000/µL within the past year on a sample without clumping
- •Prior history of invasive fungal infections
- •History of untreated cervical dysplasia or intraepithelial neoplasia (CIN)
- •Seropositive for Trypanosoma cruzi of Human T-lymphotropic virus type I or type II (HTLV-I/II) (testing in endemic regions only)
- •Any other illness or infection (latent or active) that, in the Investigator's opinion, could be execerbated by alemtuzumab treatment
- •Any hepatic or renal function value grade 2 or higher at Screening with the exception of hyperbilirubin
研究者
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