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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 August 9, 2018

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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Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease
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)
Adults 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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Crohn's Disease
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
265
October 9, 2015
February 7, 2014   (Final data collection date for primary outcome measure)

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
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,   Bulgaria,   Canada,   France,   Germany,   Japan,   Korea, Republic of,   Netherlands,   Norway,   Poland,   Serbia,   Slovakia,   South Africa,   Spain,   United States
Croatia,   Portugal,   Sweden
 
NCT01276509
A7281006
2010-023437-30 ( EudraCT Number )
OPERA ( Other Identifier: Alias Study 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

BY EMAIL

Contact

[email protected]



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