Conditions: Crohn's Disease Ileitis Ileo-colonic and Colonic Crohn's Disease Granulomatous Colitis Regional Enteritis Ulcerative Colitis
Keywords: Crohn's disease lumbar puncture anti-MAdCAM monoclonal antibody PF-00547659 Ulcerative Colitis
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 49
Healthy volunteers: no

Brief summary:
Study is designed to show a lack of effect on white blood cells circulating in the spinal fluid.

Detailed description:

Arms:
arm 1: Interventions prior to treatment. Control arm arm 2: Interventions prior to and after 3 monthly injections

Interventions: intervention 1: lumbar puncture intervention 2: lumbar puncture
Intervention descriptions: intervention 1: 2 lumbar punctures prior to treatment; study drug 225mg SC once a month X 3 doses. intervention 2: 1 lumbar puncture before and after 3 doses; study drug 225mg SC once a month X 3 doses.

Protocol document: