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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 November 17, 2019

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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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Descriptive Information
Brief Title  ICMJE Evaluate PF-00547659 On Cerebrospinal Fluid Lymphocytes In Volunteers With Crohn's Disease Or Ulcerative Colitis Who Failed Or Did Not Tolerate Anti-TNFs
Official Title  ICMJE 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)
Brief SummaryStudy is designed to show a lack of effect on white blood cells circulating in the spinal fluid.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Crohn's Disease
  • Ileitis
  • Ileo-colonic and Colonic Crohn's Disease
  • Granulomatous Colitis
  • Regional Enteritis
  • Ulcerative Colitis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications *Stüve O, Cataldi F, Pradhan V, Gorelick KJ. Normal intrathecal leukocyte cell number and composition do not decrease the incidence of post-lumbar puncture headache. J Neuroimmunol. 2017 Sep 15;310:69-71. doi: 10.1016/j.jneuroim.2017.06.011. Epub 2017 Jun 30.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 20, 2016)
49
Original Estimated Enrollment  ICMJE
 (submitted: June 30, 2011)
40
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion DateMarch 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   France,   Germany,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01387594
Other Study ID Numbers  ICMJE A7281008
2011-001443-74 ( EudraCT Number )
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyShire
Study Sponsor  ICMJE Shire
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountShire
Verification DateApril 2017

ICMJE     Data element required by the

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

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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