NCT00741910已完成2 期
Extension Study of CNI-1493 for Treatment of Moderate to Severe Crohn's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 8
- 主要终点
- Crohn's Disease Activity Index (CDAI)
研究概览
简要总结
Study CNI-1493-CD06 is an open, single-arm extension studies to CD03 and CD05. CDAI is the only efficacy measure assessed in this study. The safety of multiple courses of semapimod is to be determined by the incidence of clinical and laboratory adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study was open to patients who had satisfactorily completed either study CNI-1493-CD-03 or CNI-1493-CD-
- •Initial entry criteria were:
- •Patients who satisfactorily completed either study CNI-1493-CD-03 or CD-05 were eligible for participation in this study. Satisfactory completion was defined as follows:
- •The patient completed 5 treatment courses in the previous trial.
- •The patient had responded to treatment, as defined by a decrease in CDAI of at least 70 points from original baseline (prior to treatment on study CD-02 or CD-04) at the last assessment for study CD-03 or CD-05, respectively. The decrease had to be attributable to semapimod treatment. Thus, patients whose response was attributable to other anti-Crohn's disease therapy are not to be included.
- •The patient had no adverse event >grade 2 felt to be probably or definitely related to study medication.
- •The patient did not meet any discontinuation criterion in previous trial.
- •Patients had to sign informed consent specifically for this study, in addition to the consents for the previous studies, CNI-1493-CD-02 or CD-03, and CNI-1493-CD-04 or CD-
- •Patients could not take any other investigational therapies during the course of this study.
- •Men and women of childbearing potential had to be using a barrier method (diaphragm or condom) of contraception and continue doing so for at least 3 months after last study medication. It was strongly recommended that two forms be used.
- •Patients had to be able to adhere to the study visit schedule and/or protocol requirements.
排除标准
- •Could not have met any of the exclusion criteria for the CD02, 03, 04 or 05 studies.
研究组 & 干预措施
1
Experimental
Semapimod 60 mg IV q 6 - 10 weeks
干预措施: Semapimod (Drug)
结局指标
主要结局
Crohn's Disease Activity Index (CDAI)
时间窗: Every 6 - 10 weeks
次要结局
- Safety(Every 6 - 10 weeks)
研究者
研究点 (8)
Loading locations...
相似试验
已完成
2 期
Long-term Study of Semapimod (CNI-1493) for Treatment of Crohn's DiseaseCrohn's DiseaseNCT00740103Ferring Pharmaceuticals119
已完成
2 期
An Extension Study of the Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing Multiple SclerosisMultiple SclerosisNCT00670449Novartis143
已完成
4 期
Extension Study of Zemaira® i.v. Administration in Subjects With Emphysema Due to alpha1-proteinase Inhibitor Deficiency.Alpha 1-proteinase Inhibitor DeficiencyEmphysemaNCT00670007CSL Behring140
已完成
3 期
6-Month Extension Trial of Asenapine With Olanzapine in Negative Symptoms Patients Who Completed the First 6- Month Trial (A7501014)(COMPLETED)(P05772)SchizophreniaNCT00174265Organon and Co196
已完成
3 期
Long-term Extension to Study AC-058B301 to Investigate Safety, Tolerability and Disease Control of Ponesimod 20 mg in Patients With Relapsing Multiple SclerosisMultiple SclerosisNCT03232073Actelion877