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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

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
UAB Hospital
Birmingham, Alabama, 35249 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

NCT01287897
Pfizer
Completed
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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A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy
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)
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Crohn's Disease
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
February 2015
September 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Brazil,   Canada,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Hungary,   Ireland,   Israel,   Italy,   New Zealand,   Romania,   Switzerland,   United Kingdom,   United States
Sweden
 
NCT01287897
B0151003
2010-023034-23 ( EudraCT Number )
ANDANTE ( Other Identifier: Alias Study Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2015

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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[email protected]



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