Study Of Human Monoclonal Antibody To Il-12 For Treatmen

本研究的目的是确定抗il -12抗体治疗活动性克罗恩病的安全性和有效性。在这一年中，我们在该方案中筛选了11名受试者并入组了8名受试者。所有患者均成功完成治疗阶段，目前正在随访中。两名受试者在最后一剂研究药物12周后病情加重，并转入标准治疗。这项研究采用安慰剂对照、双盲设计，但80%的受试者服用了活性化合物。假设大多数受试者接受了活性化合物，我们观察到疾病的临床症状显著改善，疾病的内窥镜外观改善，并有证据表明，在服用研究药物后，结肠粘膜炎症效应细胞凋亡。这项研究刚刚完成，正处于分析阶段。该方案唯一的重大变化是最终排除了有生育能力的妇女，因为可能对胎儿生殖器官发育产生影响。我们在美国国立卫生研究院招募了9名受试者。我们计划在下一次持续审查之前终止该协议。

The purpose of this study is to determine the safety and efficacy of anti-IL-12 antibody therapy in active Crohn's disease. During this year we screened 11 and enrolled 8 subjects in this protocol. All successfully completed the treatment phase, and are now in follow-up. Two subjects had exacerbations of their disease 12 weeks after the last dose of study drug, and were transferred to standard therapy. This study uses a placebo-controlled, double-blind design, but 80% of enrolled subjects get the active compound. Assuming a majority of subjects received the active compound, we have observed significant improvement in clinical symptoms of disease, improvement of the endoscopic appearance of disease, and evidence of colonic mucosal inflammatory effector cell apoptosis following administration of the study drug. This study has just been completed and is in the analysis phase. The only significant change to the protocol was the eventual exclusion of women of child-bearing potential due to potential effects on fetal reproductive organ development. We enrolled 9 subjects at the NIH. We plan to terminate this protocol prior to the next continuing review.