EUCTR2006-001729-24-ES进行中（未招募）不适用
Ensayo clínico abierto a largo plazo para evaluar la eficacia y seguridad del tratamiento crónico con certolizumab pegol, un fragmento Fab pegilado del anticuerpo humanizado dirigido al factor de necrosis tumoral alfa (TNF), en pacientes afectados por la enfermedad de Crohn que hayan terminado el estudio C87042.Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, A PEGylated Fab fragment of humanized antibofy to tumour necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study.
CB S.A.0 个研究点目标入组 250 人开始时间: 2007年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
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
- •Crohn's disease diagnosis:
- •Patients (previously treated with infliximab) having completed the maintenance phase of study C87042 and being in response. Patient remaining able to understand the information provided to them and to give written informed consent for C87046. Female patient either postmenopausal for at least, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (oral or parenteral hormonal contraceptives; intrauterine device; barrier and spermicide. Abstinence is not an acceptable method).
- •Patients must agree to continue to use adequate contraception during the study and for 12 weeks after the last dose of CDP870.
- •Concomitant medications: Same medications as in C87042 study will be allowed (5-ASA, azathioprine and 6-mercaptopurine or methotrexate).
- •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
- •Subjects must not be included if they meet any of the following criteria: Subject withdrawn prematurely from C87042 study. Subject who received treatment other than certolizumab pegol and other than medications permitted in C87042 study. Subjects from countries where certolizumab pegol is authorised in Crohn’s disease treatment.
研究者
相似试验
进行中（未招募）
不适用
Estudio abierto de tratamiento a largo plazo para evaluar la seguridad, la tolerabilidad y la eficacia a largo plazo de neramexano en pacientes con acúfenos subjetivosAn Open-Label, Long-Term Treatment Study to assess the Long-Term Safety and Tolerability and Efficacy of Neramexane in Patients with Subjective TinnitusAcúfenos subjetivosLong-term safety, tolerability and efficacy of Neramexane in Patients with subjective Tinnitus.MedDRA version: 9.1Level: LLTClassification code 10042398Term: Subjective tinnitusEUCTR2008-001432-13-ESMerz Pharmaceuticals GmbH840
进行中（未招募）
1 期
Studio nel quale tutti i pazienti prendono lo stesso farmaco sperimentale con lo scopo di valutare a lungo termine la sicurezza, la tollerabilità e l'efficacia del GIVINOSTAT in pazienti affetti da distrofia muscolare di Duchenne che sono stati precedentemente trattati in uno studio con GIVINOSTAT.EUCTR2017-000397-10-ITITALFARMACO S.p.A.100
进行中（未招募）
2 期
A 5-year study to test BI 655130 in patients with Generalized Pustular Psoriasis who took part in previous studies with BI 655130Generalized Pustular Psoriasis (GPP)JPRN-jRCT2041210087Taguchi Aya131
进行中（未招募）
1 期
A 5-year study to test BI 655130 in patients with GeneralizedPustular Psoriasis who took part in previous studies with BI655130Generalized Pustular PsoriasisMedDRA version: 21.0Level: LLTClassification code 10037159Term: Psoriasis pustularSystem Organ Class: 100000004858EUCTR2018-003080-56-ESBoehringer Ingelheim España S.A.150
进行中（未招募）
1 期
A 5-year study to test BI 655130 in patients with Generalized Pustular Psoriasis who took part in previous studies with BI 655130EUCTR2018-003080-56-FRBoehringer Ingelheim France101