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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

FOR MORE INFORMATION
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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Evaluate PF-00547659 On Cerebrospinal Fluid Lymphocytes In Volunteers With Crohn's Disease Or Ulcerative Colitis Who Failed Or Did Not Tolerate Anti-TNFs
A Multi-Center, Phase 1, Open-Label Evaluation Of The Effect Of PF-00547659 (Anti Madcam Monoclonal Antibody) On Cerebrospinal Fluid (CSF) Lymphocytes In Volunteers With Crohns Disease Or Ulcerative Colitis Who Are Anti-TNFInadequate Responders (TOSCA)
Study is designed to show a lack of effect on white blood cells circulating in the spinal fluid.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
  • Crohn's Disease
  • Ileitis
  • Ileo-colonic and Colonic Crohn's Disease
  • Granulomatous Colitis
  • Regional Enteritis
  • Ulcerative Colitis
  • 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.
  • Experimental: Cohort 1
    Interventions prior to treatment. Control arm
    Intervention: Procedure: lumbar puncture
  • Experimental: Cohort 2
    Interventions prior to and after 3 monthly injections
    Intervention: Drug: lumbar puncture
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
November 2015
March 2014   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   France,   Germany,   Netherlands
 
 
NCT01387594
A7281008
2011-001443-74 ( EudraCT Number )
Yes
Not Provided
Not Provided
Shire
Shire
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Shire
April 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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