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

PHASE1CompletedINTERVENTIONAL
Enrollment

49

Participants

Timeline

Start Date

May 3, 2012

Primary Completion Date

March 31, 2014

Study Completion Date

November 26, 2015

Conditions
Crohn's DiseaseIleitisIleo-colonic and Colonic Crohn's DiseaseGranulomatous ColitisRegional EnteritisUlcerative Colitis
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.

Trial Locations (9)

1090

AKH Wien Universitaetsklinik fuer Innere Medizin III Klinische Abteilung fuer Gastroenterologie und, Vienna

13353

Charité, Universitaetsmedizin Berlin, Campus Virchow Klinikum,, Berlin

59037

Hopital Cardiologique, Lille

Hopital Huriez, CHRU de Lille, Lille

75010

Hopital Saint-Louis - CIC, Paris

Hopital Saint-Louis, Paris

B-1000

Hopital Erasme, Brussels

B-3000

UZ Gasthuisberg, Leuven

1105 AZ

Academic Medical Center - University of Amsterdam, Dept. of Gastroenterology, Amsterdam

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY

NCT01387594 - Evaluate PF-00547659 On Cerebrospinal Fluid Lymphocytes In Volunteers With Crohn's Disease Or Ulcerative Colitis Who Failed Or Did Not Tolerate Anti-TNFs | Biotech Hunter | Biotech Hunter