NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Ulcerative Colitis
Date of first enrollment	18/05/2010
Target sample size	12
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : MLN0002 INN of investigational material : Therapeutic category code : 239 Other agents affecting digestive organs Dosage and Administration for Investigational material : MLN0002 (150 mg or 300 mg) will be administered 3 times by intravenous drip infusion.

Outcome(s)

Primary Outcome	Plasma concentration of MLN0002, adverse events, vital signs, weight, electrocardiograph findings, laboratory test results, PML (progressive multifocal leukoencephalopathy) assessment, HAHA (human anti-human antibody) assessment, and neutralizing antibody assessment Summary statistics will be calculated by dose ,etc
Secondary Outcome	Percent of alpha4beta7 receptor saturation, partial Mayo score Summary statistics will be calculated by dose ,etc

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 70age old
Gender	Both
Include criteria	1)Patients with well-defined ulcerative colitis 2)Patients who agree to use routinely adequate contraception 3)Patients weigh at least 40 kg etc
Exclude criteria	1)Patients for whom surgical intervention for their ulcerative colitis is currently required or anticipated 2)Patients with dysplasia or cancer of colon or rectum 3)Patients with symptoms of intestinal stenosis, history of intestinal resection (except for appendectomy) 4)Patients with intestinal diseases other than ulcerative colitis (radiation colitis, ischemic colitis, drug-induced colitis, Crohn's disease, intestinal Behcet disease, lymphoid follicular hyperplasia, etc.) 5)Patients with presence or history of active or latent tuberculosis 6)Female patients who are pregnant or lactating 7)Patients with prior exposure to MLN0002, natalizumab, rituximab, or efalizumab etc