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Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease

Last updated on December 5, 2019

FOR MORE INFORMATION
Study Location
Clopton Clinic
Jonesboro, Arkansas, 72401 United States
Contact
1-800-718-1021
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 and/or immunosuppressants
(AZA, 6-MP, and/or MTX).

- hsCRP greater than 3mg/L

- Ulcerations demonstrated by colonoscopy performed during screening or 8 weeks prior
to screening

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

- Pregnant or breast feeding

- Short bowel syndrome due to multiple small bowel resections

- Presence of a stoma

NCT01276509
Pfizer
Completed
Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease

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Descriptive Information
Brief Title  ICMJE Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease
Official Title  ICMJE A Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-00547659 In Subjects With Crohn's Disease (Opera)
Brief SummaryAdults with Crohn's disease that is clinically active despite conventional treatment will be eligible for this study. Patients may receive one of three doses of PF-00547659 (experimental drug) or placebo (inactive drug). Disease activity will be measured every two weeks.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease
Intervention  ICMJE
  • Drug: PF-00547659 SC injection
    Placebo delivered SC, 3 doses separated by 4 weeks
  • Drug: PF-00547659 SC injection
    Drug dose level 1 delivered SC, 3 doses separated by 4 weeks
  • Drug: PF-00547659 SC injection
    Drug dose level 2 delivered SC, 3 doses separated by 4 weeks
  • Drug: PF-00547659 SC injection
    Drug dose level 3 delivered SC, 3 doses separated by 4 weeks
Study Arms  ICMJE
  • Placebo Comparator: Placebo-SC Injection
    Placebo delivered SC, 3 doses separated by 4 weeks.
    Intervention: Drug: PF-00547659 SC injection
  • Experimental: Drug Dose level 1- SC injection
    Drug dose level 1 delivered SC, 3 doses separated by 4 weeks.
    Intervention: Drug: PF-00547659 SC injection
  • Experimental: Drug Dose level 2-SC injection
    Drug dose level 2 delievered SC, 3 doses separated by 4 weeks.
    Intervention: Drug: PF-00547659 SC injection
  • Experimental: Drug Dose level 3- SC injection
    Drug dose level 3 delivered SC, 3 doses separated by 4 weeks.
    Intervention: Drug: PF-00547659 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: December 7, 2015)
265
Original Estimated Enrollment  ICMJE
 (submitted: January 12, 2011)
240
Actual Study Completion Date  ICMJE October 9, 2015
Actual Primary Completion DateFebruary 7, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects must have failed or are intolerant to anti-TNFs and/or immunosuppressants (AZA, 6-MP, and/or MTX).
  • hsCRP greater than 3mg/L
  • Ulcerations demonstrated by colonoscopy performed during screening or 8 weeks prior to screening

Exclusion Criteria:

  • Pregnant or breast feeding
  • Short bowel syndrome due to multiple small bowel resections
  • Presence of a stoma
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,   Bulgaria,   Canada,   France,   Germany,   Japan,   Korea, Republic of,   Netherlands,   Norway,   Poland,   Serbia,   Slovakia,   South Africa,   Spain,   United States
Removed Location CountriesCroatia,   Portugal,   Sweden
 
Administrative Information
NCT Number  ICMJE NCT01276509
Other Study ID Numbers  ICMJE A7281006
2010-023437-30 ( EudraCT Number )
OPERA ( Other Identifier: Alias Study 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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Pfizer Clinical Trials Contact Center

1-800-718-1021

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