Evaluate PF-00547659 On Cerebrospinal Fluid Lymphocytes In Volunteers With Crohn's Disease Or Ulcerative Colitis Who Failed Or Did Not Tolerate Anti-TNFs

• Status: Completed
• Trial end date: 2015-11-26
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Shire
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

• males and females >=18 and =<75 years

• For CD subjects: hsCRP > 5 mg/L and Harvey-Bradshaw Index > 8 OR when HBI cannot be determined (ie if stoma is present) or hsCRP < 5mg/L then: active lesions on colonoscopy or flexible sigmoidoscopy or active Crohn's disease on CT or MR enterography

• For UC subjects: diagnosis of UC > 3 months; must have endoscopy to confirm active disease during screening; total mayo score of 6 to 12 points and moderate to severe disease on endoscopy

Exclusion Criteria:

• Pregnancy or breastfeeding

• TB or active enteric infections

• Entero vesicular fistulae

• Prior use of natalizumab or vedolizumab

• Right or left heart failure including symptomatic diastolic dysfunction or unexplained elevation of troponin I (>0.05 ng/mL)