EUCTR2006-002204-33-ES进行中（未招募）1 期
Double-blind, placebo-controlled, randomized, parallel-group Phase II study in subjects with relapsing forms of multiple sclerosis (MS) to evaluate the safety, tolerability, and effects of two doses of CDP323 over 24 weeks with a rater-blind MRI follow-up over 12 weeks.Estudio de fase II, doble ciego, aleatorizado, controlado con placebo, y de grupos paralelos, en pacientes con esclerosis múltiple (EM) con recaídas, para evaluar la seguridad, la tolerabilidad y los efectos de dos dosis distintas de CDP323 a lo largo de 24 semanas, con seguimiento ciego mediante resonancia magnética (RM) durante 12 semanas.
CB Pharma0 个研究点目标入组 279 人开始时间: 2007年3月5日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 279
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
- •written informed consent;
- •able to understand the nature of the study and its potential risks;
- •willing to comply with the study's safety precautions and with the intended drug-free long-term follow-up over the telephone;
- •diagnosis of MS according to the revised McDonald criteria (Polman et al. Ann Neurol 2005;58:840-6);
- •relapsing form of MS, i.e., RRMS or SPMS (with superimposed relapses) according to Lublin and Reingold (Neurology 1996;46:907-11);
- •screening EDSS score of 0-5.5, inclusive;
- •female and male subjects aged 18-55 years inclusive at time of informed consent;
- •at least one clinical relapse in the 12 months before screening and documented in the subject's medical records;
- •active disease, defined by the presence of either,
- •at least nine lesions on the screening T2 scan or,
- •Gd enhancement on the screening T1 scan or,
- •Gd enhancement on an MRI scan during the past 12 months or,
- •at least two new T2 lesions during the past 12 months;
- •failed prior treatment with beta-interferons due to lack of efficacy or tolerability;
- •female subjects of childbearing potential must agree to practice one of the following contraception method:
- •double-barrier contraception (i.e., using a male or female condom with
- •spermicide, or diaphragm or cervical cap with spermicide) or
- •any contraceptives containing estrogens plus one of the following:
- •diaphragm or cervical cap with spermicide, male or female condom with
- •spermicide or
- •intrauterine devices or
- •contraceptives containing progestins only, e.g., etonogestrel or
- •levonorgestrel or medroxyprogesterone or norethindrone or
- •monogamous relationship with vasectomized partner or,
- •sexual abstinence.
- •Note: Lack of childbearing potential will be considered under these
- •circumstances:
- •post-menopausal for at least two years,
- •bilateral oophorectomy, ovariectomy, salpingectomy, or tubal ligation,
- •hysterectomy;
- •congenital sterility.
- •negative pregnancy tests at screening and at baseline for female subjects of
- •childbearing potential;
- •full immunocompetency: CD4+ lymphocyte count within reference range;
- •JC viral DNA particles undetectable in blood at two separate measurements.
- •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
- •type of MS other than relapsing;
- •any disease other than MS that could better explain the subject's signs and symptoms;
- •any conditions that could interfere with the MRI or any other evaluation in the study;
- •any clinically significant disease state or findings other than MS, in particular
- •neoplastic disease or organ transplantation (in case of doubt, UCB's responsible
- •medical officer will be consulted and a joint documented decision will be made
- •between investigator and UCB's medical officer);
- •any clinically significant deviation from reference ranges in laboratory tests or any
- •abnormal, clinically significant ECG findings, in particular any marked pre-study
- •prolongation of the QTcB interval, i.e., if both, the Screening (V1) and the Baseline
- •(V3) ECG demonstrate a QTcB interval >450 ms (in case of doubt, UCB's responsible
- •medical officer will be consulted and a joint documented decision will be made
- •between investigator and UCB's medical officer);
- •any significant deviation from reference ranges for hepatic function as defined by either SGOT, SGPT, GGT, or AP elevated 3-fold or higher beyond the upper limit of the
- •reference range or total bilirubin elevated 2-fold or higher beyond the upper limit of the reference range;
- •signs of silent infections, including positive tests for HIV1, HIV2, or Hepatitis B or
- •Hepatitis C, or tuberculosis;
- •any condition possibly interfering with drug absorption;
- •known allergy to gadolinium-DTPA, and/or ingredients of the study drug formulation;
- •history of severe AEs to any drug;
- •participation in any clinical drug trial within 30 days prior to screening;
- •concomitant treatment with theophylline or warfarin or the following drugs known for their potential to interfere with cardiac repolarization: amiodarone, arsenic trioxide, bepredil, budipine, cisapride, chinidine (quinidine), chloroquine, chlorpromazine, clarithromycin, disopyramide, dofetilide, domperidone, droperidol, erythromycin, halofantrine, haloperidol, ibutilide, levomethadyl, mesoridazine, methadone, pentamidine, pimozide, procainamide, sotalol, sparfloxacin, thioridazine
- •pre-treatment with the following substances prior to screening within the following
- •time frames:
- •at any time: natalizumab, mitoxantrone or cyclophosphamide; total lymphoid
- •irradiation; anti-lymphocyte monoclonal antibody treatment (e.g., anti-CD4,
- •Campath-1H);
- •up to 30 days prior to screening: any interferons, glatiramer acetate,
- •corticosteroids and ACTH, IvIg, cyclosporine A, human antibodies, any other
- •immunomodulating or immunosuppressive drugs including recombinant
- •cytokines, any other putative or experimental MS treatment;
- •six month prior to screening: azathioprine
- •pregnancy or lactation;
- •history of alcohol or drug abuse within the year before screening;
- •medical, psychiatric or other conditions that compromise the subject's ability to
- •understand the subject information, to give informed consent, to comply with the trial
- •protocol, or to complete the study;
- •any reason why, in the investigator's opinion, the subject should not participate.
- •If a subject suffers a relapse during the screening phase, he/she may not be randomized on the planned SoT visit. He/she may be randomized 30 days ± 3 days after the end of the last relapse.
研究者
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