EUCTR2017-001003-74-HU进行中（未招募）1 期
A Multicenter, Open-Label, Follow-Up Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects with Psoriatic Arthritis
CB Biopharma SPR0 个研究点目标入组 200 人开始时间: 2017年8月29日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
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
- •- In the opinion of the Investigator, the subject is expected to benefit from participation in an Open Label Extension (OLE) study
- •- Subject completed PA0008 without meeting any withdrawal criteria
- •- Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception - Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active
- •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 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •- Female subjects who plan to become pregnant during the study or within 20 weeks following the last dose of IMP. Male subjects who are planning a partner pregnancy during the study or within 20 weeks following the last dose
- •- Subjects with any current sign or symptom that may indicate a medically significant active infection (except for the common cold) or has had an infection requiring systemic antibiotics within 2 weeks of study entry
- •- Subjects who meet any withdrawal criteria in PA0008. For any subject with an ongoing Serious Adverse Event, or a history of serious infections (including hospitalizations) in the lead-in study, the Medical Monitor must be consulted prior to the subject’s entry into PA0009
研究者
相似试验
进行中（未招募）
1 期
A Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects with Psoriatic ArthritisPsoriatic ArthritisEUCTR2017-001003-74-CZCB Biopharma SPR200
进行中（未招募）
1 期
A Study to Evaluate the Long-Term Safety and Efficacy of Bimekizumab in Subjects with Psoriatic ArthritisMedDRA version: 21.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859Psoriatic ArthritisEUCTR2017-001003-74-DECB Biopharma SR200
进行中（未招募）
不适用
Effectiveness and safety of BGG492 as add-on treatment in patients with partial onset seizuresEpilepsy Partial onset seizuresMedDRA version: 13.1Level: PTClassification code 10061334Term: Partial seizuresSystem Organ Class: 10029205 - Nervous system disordersEUCTR2010-021448-17-DEovartis Pharma Services AG62
进行中（未招募）
不适用
A multicenter, open-label, follow-up study to evaluate the long-term safety and tolerability of BGG492 TID as adjunctive therapy in patients with partial onset seizures completing double-blind, placebo-controlled study CBGG492A2207 or CBGG492A2211. - not availableEpilepsy Partial onset seizuresMedDRA version: 12.1Level: LLTClassification code 10065336Term: Partial epilepsyEUCTR2010-021448-17-HUovartis Pharma Services AG
进行中（未招募）
不适用
A multicenter, open-label, follow-up study to evaluate the long-term safety and tolerability of BGG492 TID as adjunctive therapy in patients with partial onset seizures completing double-blind, placebo-controlled study CBGG492A2207 or CBGG492A2211. - not availableEUCTR2010-021448-17-SKovartis Pharma Services AG62