A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy

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NCT01287897

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Study Location
UAB Hospital
Birmingham, Alabama, 35249, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Crohn's Disease
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

- Subjects must have failed or are intolerant to anti TNFs

- hsCRP greater or equal to 5.0 mg/L

- Ulcerations demonstrated by colonoscopy as defined by SES CD assessment performed within 8 weeks of study entry (screening) and able to retrospectively complete the SES-CD or colonoscopy performed during screening

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


- Pregnant or breastfeeding women


- Crohn's Disease with active fistulae or abscess


- History of diverticulitis or symptomatic diverticulosis


- Abnormality in hematology or chemistry profiles at screening

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy
Official Title  ICMJE A Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Crohn's Disease Who Are Anti-tnf Inadequate Responders (Andante)
Brief Summary This is a proof of concept study to determine the efficacy and safety of a monoclonal antibody with three doses versus placebo. Subjects will be randomized to a treatment and the dose will be delivered subcutaneously twice, 4 weeks apart. All subjects will have moderate to severe refractory Crohn's Disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease
Intervention  ICMJE
  • Drug: PF-04236921 SC injection
    Placebo delivered SC, 2 doses separated by 4 weeks
  • Drug: PF-04236921 SC injection
    Drug dose level 1 delivered SC, 2 doses separated by 4 weeks
  • Drug: PF-04236921 SC injection
    Drug dose level 2 delivered SC, 2 doses separated by 4 weeks
Study Arms  ICMJE
  • Placebo Comparator: Placebo- SC injection
    Intervention: Drug: PF-04236921 SC injection
  • Experimental: Drug Dose level 1 - SC injection
    Intervention: Drug: PF-04236921 SC injection
  • Experimental: Drug Dose level 2 - SC injection
    Intervention: Drug: PF-04236921 SC injection
Publications *

*   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: February 12, 2015)		250
Original Estimated Enrollment  ICMJE
 (submitted: January 31, 2011)		240
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects must have failed or are intolerant to anti TNFs
  • hsCRP greater or equal to 5.0 mg/L
  • Ulcerations demonstrated by colonoscopy as defined by SES CD assessment performed within 8 weeks of study entry (screening) and able to retrospectively complete the SES-CD or colonoscopy performed during screening

Exclusion Criteria:

  • Pregnant or breastfeeding women
  • Crohn's Disease with active fistulae or abscess
  • History of diverticulitis or symptomatic diverticulosis
  • Abnormality in hematology or chemistry profiles at screening
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 Australia,   Belgium,   Brazil,   Canada,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Hungary,   Ireland,   Israel,   Italy,   New Zealand,   Romania,   Switzerland,   United Kingdom,   United States
Removed Location Countries Sweden
 
Administrative Information
NCT Number  ICMJE NCT01287897
Other Study ID Numbers  ICMJE B0151003
2010-023034-23 ( EudraCT Number )
ANDANTE ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP