ACTRN12613001027707已完成未知
Developing systems to minimise the risk of multiple sclerosis (MS) treatment with alemtuzumab
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.Willing to provide informed consent to both treatment with alemtuzumab and inclusion in the PRIME clinical decision support system monitoring procedures
- •2.Age 18 or older as of the date the consent is signed
- •3.Definite relapsing remitting MS by McDonald 2010 criteria
- •4.Cranial MRI scan demonstrating white matter lesions attributable to MS within 1 year of Screening
- •5.Active MS as signified by at least 2 relapses in the last 2 years and at least 1 relapse in the last 1 year
- •a.Failure of first line disease-modifying treatment as determined by: at least 1 relapse of MS despite treatment with a TGA-approved treatment for MS (interferons, glatiramer, teriflunomide, fingolimod or natalizumab), or at least 1 relapse in a patient unable to be treated with TGA-approved MS treatments due to intolerance or unacceptable risks of these treatments
- •b.Previously untreated MS that is associated with at least one gadolinium enhancing lesion on MRI in the last 1 year.
- •7.Diagnosed disease duration <= 10years
- •8.Baseline EDSS 0 – 4.0
排除标准
- •a.As per CAMMS03409 amendment 2:
- •i.Does not wish to receive alemtuzumab
- •ii.Ongoing participation in any other investigational study
- •iii.Has received alemtuzumab off-label
- •iv.Known bleeding disorder (eg, dysfibrinogenemia, factor IX deficiency, hemophilia, Von Willebrand's disease, Disseminated Intravascular Coagulation [DIC], fibrinogen deficiency, or other clotting factor deficiency) or therapeutic anticoagulation
- •v.Diagnosis of immune thrombocytopenic purpura (ITP), or other autoimmune hematologic abnormality.
- •vi.History of malignancy, except basal cell skin carcinoma
- •vii.Intolerance of pulsed corticosteroids, especially a history of steroid psychosis
- •viii.Significant non-MS autoimmune disease including but not limited to: immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders, vasculitis, inflammatory bowel disease, severe psoriasis, or anti-glomerular basement membrane disease (anti-GBM disease, also known as Goodpasture’s disease)
- •ix.Major psychiatric disorder or epileptic seizures not adequately controlled by treatment
- •x.Known infection with hepatitis B or C virus, seropositivity for human immunodeficiency virus (HIV).
- •xi.History of invasive fungal infections
- •xii.Unwilling to agree to use a reliable and acceptable contraceptive method for at least 6 months following each alemtuzumab treatment cycle (fertile patients only). Reliable and effective contraceptive method(s) include: intrauterine device (IUD), hormonal-based contraception, surgical sterilization, abstinence or double-barrier contraception (condom and occlusive cap [diaphragm or cervical cap with spermicide])
- •b.Plus (local exclusion criteria)
- •i.Not resident in NSW
- •ii.Not able to access Douglass Hanly Moir pathology services
- •iii.Not able or likely to fulfil the requirements of the study for any other reason
- •iv.Not able to access electronic reminders and alerts (patient must have both a mobile (cell) phone and a valid regularly checked email address, the patient’s designate person must have at least one of these two methods of contact, prefer both)
- •v.Allergic or intolerant of any agent required for the completion of this study (i.e alemtuzumab, gadolinium contrast)
- •vi.No history of primary infection or vaccination with varicella zoster virus, until vaccinated
- •vii.Other significant active or latent infection until treated
- •viii.Any other reason that an investigator regards as a contraindication to entering or ability to complete the study
- •c.The following are not exclusion criteria but caution should be exercised in including patients with these criteria noting that these were exclusion criteria for the alemtuzumab RCTs
- •i.Prior exposure to natalizumab, fingolimod, mitoxantrone, azathioprine, cladribine, cyclophosphamide, cyclosporine A, methotrexate, or any other immunosuppressive agent
- •ii.Patients > 50 years of age
- •iii.Disease duration 5-10 years after diagnosis
- •iv.EDSS 3.5-4
- •v.Patients with known thyroid autoimmunity or thyroid antibodies. Such patients are highly likely to develop clinical thyroid autoimmunity and this should be discussed with the patient.
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