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

NCT01387594 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2021-06-03

Study results available
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Summary

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

Conditions

Interventions

PROCEDURE

lumbar puncture

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

DRUG

lumbar puncture

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

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-03
Primary Completion
2014-03-31
Completion
2015-11-26

Countries

  • Austria
  • Belgium
  • France
  • Germany
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01387594 on ClinicalTrials.gov