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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

Last updated on August 9, 2018

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Study Location
AKH Wien Universitaetsklinik fuer Innere Medizin III Klinische Abteilung fuer Gastroenterologie und
Wien, , 1090 Austria
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Crohn's Disease, Ileitis, Ileo-colonic and Colonic Crohn's Disease, Granulomatous Colitis, Regional Enteritis, Ulcerative Colitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- males and females >=18 and =

- 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 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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)

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

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1-800-718-1021

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