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The Safety And Efficacy Of Maintenance Therapy With CP-690,550

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NCT01393899

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
ACMG Endoscopy Center
Anaheim, California, 92801 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 who met study entry criteria, and who completed Week 8 visit of Induction
Study A3921083.

- Subjects who achieve clinical response-100 (reduction in CDAI by 100 points) and/or
clinical remission (CDAI

- Women of childbearing potential must test negative for pregnancy prior to study
enrolment.

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

- Subjects who had major protocol violation (as determined by the Sponsor) in the
A3921083 study.

- Subjects likely to require any type of surgery during the study period.

- Fecal culture/toxin assay indicating presence of pathogenic infection.

NCT01393899
Pfizer
Completed
The Safety And Efficacy Of Maintenance Therapy With CP-690,550

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The Safety And Efficacy Of Maintenance Therapy With CP-690,550
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Centre Study To Investigate The Safety And Efficacy Of CP-690,550 For Maintenance Therapy In Subjects With Moderate To Severe Crohn's Disease
This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease who completed the double-blind induction treatment in Study A3921083 and achieved clinical response-100 and/or clinical remission (CDAI<150) at Week 8.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Crohn's Disease
  • Drug: Placebo
    oral tablets twice daily
  • Drug: CP-690,550
    oral tablets twice daily
  • Placebo Comparator: Placebo BID
    Intervention: Drug: Placebo
  • Experimental: 5mg BID
    Intervention: Drug: CP-690,550
  • Experimental: 10mg BID
    Intervention: Drug: CP-690,550
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
July 2015
July 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who met study entry criteria, and who completed Week 8 visit of Induction Study A3921083.
  • Subjects who achieve clinical response-100 (reduction in CDAI by 100 points) and/or clinical remission (CDAI<150) in Study A3921083.
  • Women of childbearing potential must test negative for pregnancy prior to study enrolment.

Exclusion Criteria:

  • Subjects who had major protocol violation (as determined by the Sponsor) in the A3921083 study.
  • Subjects likely to require any type of surgery during the study period.
  • Fecal culture/toxin assay indicating presence of pathogenic infection.
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,   Austria,   Bulgaria,   Canada,   Czech Republic,   France,   Germany,   Greece,   Hungary,   Israel,   Japan,   Korea, Republic of,   Netherlands,   South Africa,   Spain,   Ukraine,   United States
Croatia,   India
 
NCT01393899
A3921084
2011-001754-28 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2016

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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1-800-718-1021

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