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

NCT01393899

Last updated date
Study Location
ACMG Endoscopy Center
Anaheim, California, 92801, United States
Contact
1-800-718-1021

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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 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
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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE The Safety And Efficacy Of Maintenance Therapy With CP-690,550
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease
Intervention  ICMJE
  • Drug: Placebo
    oral tablets twice daily
  • Drug: CP-690,550
    oral tablets twice daily
Study Arms  ICMJE
  • Placebo Comparator: Placebo BID
    Intervention: Drug: Placebo
  • Experimental: 5mg BID
    Intervention: Drug: CP-690,550
  • Experimental: 10mg BID
    Intervention: Drug: CP-690,550
Publications * Panés J, Sandborn WJ, Schreiber S, Sands BE, Vermeire S, D'Haens G, Panaccione R, Higgins PDR, Colombel JF, Feagan BG, Chan G, Moscariello M, Wang W, Niezychowski W, Marren A, Healey P, Maller E. Tofacitinib for induction and maintenance therapy of Crohn's disease: results of two phase IIb randomised placebo-controlled trials. Gut. 2017 Jun;66(6):1049-1059. doi: 10.1136/gutjnl-2016-312735. Epub 2017 Feb 16.

*   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: November 10, 2016)
180
Original Estimated Enrollment  ICMJE
 (submitted: July 12, 2011)
90
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
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,   Austria,   Bulgaria,   Canada,   Czech Republic,   France,   Germany,   Greece,   Hungary,   Israel,   Japan,   Korea, Republic of,   Netherlands,   South Africa,   Spain,   Ukraine,   United States
Removed Location Countries Croatia,   India
 
Administrative Information
NCT Number  ICMJE NCT01393899
Other Study ID Numbers  ICMJE A3921084
2011-001754-28 ( EudraCT 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 November 2016

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