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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-03

Study Completion Date

2015-11-26

Brief Summary

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

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Cohort 1

Interventions prior to treatment. Control arm

Group Type EXPERIMENTAL

lumbar puncture

Intervention Type PROCEDURE

2 lumbar punctures prior to treatment; study drug 225mg SC once a month X 3 doses.

Cohort 2

Interventions prior to and after 3 monthly injections

Group Type EXPERIMENTAL

lumbar puncture

Intervention Type DRUG

1 lumbar puncture before and after 3 doses; study drug 225mg SC once a month X 3 doses.

Interventions

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lumbar puncture

2 lumbar punctures prior to treatment; study drug 225mg SC once a month X 3 doses.

Intervention Type PROCEDURE

lumbar puncture

1 lumbar puncture before and after 3 doses; study drug 225mg SC once a month X 3 doses.

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No