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

Shire

Status and phase: Completed; Phase 1

Conditions: Ileo-colonic and Colonic Crohn's Disease; Ulcerative Colitis; Granulomatous Colitis; Crohn's Disease; Regional Enteritis; Ileitis

Treatments: Drug: lumbar puncture

Study type: Interventional

Funder types: Industry

Identifiers

NCT01387594

A7281008

2011-001443-74 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 49 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Cohort 1

Experimental group

Description:

Interventions prior to treatment. Control arm

Cohort 2

Experimental group

Description:

Interventions prior to and after 3 monthly injections

Treatment:

Drug: lumbar puncture

Drug: lumbar puncture