A Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Fingolimod 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Mitsubishi Tanabe Pharma Corporation, Novartis Pharma K.K.0 个研究点目标入组 156 人开始时间: 2012年9月12日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1. Written informed consent must be obtained before any assessment is performed.
•2. The diagnosis of CIDP will use the definition of the EFNS/PNS Task Force First Revision. Patients must either have a clinical diagnosis of CIDP fulfilling the clinical inclusion criteria for typical CIDP or one of the following atypical forms of CIDP:
•*pure motor, or
•*asymmetrical (MADSAM [Lewis-Sumner syndrome]), or
•*IgA or IgG (not IgM) MGUS paraprotein associated.
•3. Disability defined by an INCAT Disability Scale score of 1-9 or, if INCAT score is 0, a documented history of disability sufficient to require treatment within the past 2 years following reduction or interruption of CIDP treatment.
•4. Receiving IVIg treatment (minimal dose equivalent to 0.4 g/kg every 4 weeks for a minimum of 12 weeks) or corticosteroids (minimal dose equivalent to prednisone 10 mg/day) treatment prior to the screening visit.
•5. History of documented clinically meaningful deterioration confirmed by clinical examination, during therapy or upon interruption or reduction of therapy within 1 year prior to Screening.
•6. Stable CIDP symptoms without significant change in treatment regimen for the 2 months before randomization.
•7. Male or female aged 18 years or older at Screening.

•1. Other chronic demyelinating neuropathies, including:
•-Distal Acquired Demyelinating Symmetric neuropathy (DADS),
•-Multifocal Motor Neuropathy (MMN),
•-pure sensory CIDP,
•-hematopoietic malignancy except for MGUS IgG or IgA.
•2. Conditions in which the pathogenesis of the neuropathy may be different from CIDP such as: Lyme disease, POEMS syndrome, osteosclerotic myeloma, Castleman's disease.
•3. Treatment with:
•-plasma exchange within 2 months of randomization.
•-immunosuppressive/chemotherapeutic medications:
•-azathioprine, cyclophosphamide, cyclosporine, mycophenolate, etanercept, methotrexate, tacrolimus or other immunosuppressive drugs within 6 months of randomization;
•-rituximab in the 2 years prior to randomization;
•-other cytotoxic immunosuppressive medications with sustained effects (including mitoxantrone, alemtuzumab, cladribine) at any time;
•-hematopoietic stem cell transplantation at any time.
•4. Patients with an active chronic disease (or stable but treated with immune therapy) of the immune system other than MS (e.g., rheumatoid arthritis, scleroderma, Sjogren's syndrome, Crohn's disease, or ulcerative colitis) or with a known immunodeficiency syndrome (human immunodeficiency virus [HIV]-antibody positive, AIDS, hereditary immune deficiency, or drug-induced immune deficiency).

发起方

Mitsubishi Tanabe Pharma Corporation, Novartis Pharma K.K.