A Study To Investigate Safety And Efficacy Of CP-690,550 For Induction Therapy In Subjects With Moderate To Severe Crohn's Disease

NCT01393626

Last updated date
Study Location
ACRI - Phase 1, LLC
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

- Male or female subjects between the ages of 18 and 75 years at screening (upper age limit will be 64 years in India and 65 years in the Netherlands).

- Subjects with clinical diagnosis of Crohn's disease for at least 6 months prior to screening.

- Subjects with active moderate to severe ileal, ileocolic, or colonic CD defined by a baseline score of Crohn's Disease Activity Index (CDAI) of 220 to 450 at baseline.

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


- Diagnosis of indeterminate colitis, ulcerative colitis (UC), or clinical findings
suggestive of UC.


- Subjects diagnosed with Crohn's disease but without previous exposure to treatment
(i.e., treatment-naïve).


- Subjects receiving the following treatment for Crohn's disease:


- Azathioprine, 6-mercaptopurine or methotrexate within 2 weeks prior to baseline.


- Anti-TNFα therapy within 8 weeks prior to baseline.


- Interferon therapy within 8 weeks prior to baseline.


- Cyclosporine, mycophenolate, or tacrolimus within 4 weeks prior to baseline.


- Intravenous corticosteroids within 2 weeks prior to baseline.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study To Investigate Safety And Efficacy Of CP-690,550 For Induction Therapy In Subjects With Moderate To Severe Crohn's Disease
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 Induction 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. The study hypothesis is that at least one dose of the tested drug is more effective than placebo (inactive drug).
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: May 22, 2015)
280
Original Estimated Enrollment  ICMJE
 (submitted: July 11, 2011)
275
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female subjects between the ages of 18 and 75 years at screening (upper age limit will be 64 years in India and 65 years in the Netherlands).
  • Subjects with clinical diagnosis of Crohn's disease for at least 6 months prior to screening.
  • Subjects with active moderate to severe ileal, ileocolic, or colonic CD defined by a baseline score of Crohn's Disease Activity Index (CDAI) of 220 to 450 at baseline.

Exclusion Criteria:

  • Diagnosis of indeterminate colitis, ulcerative colitis (UC), or clinical findings suggestive of UC.
  • Subjects diagnosed with Crohn's disease but without previous exposure to treatment (i.e., treatment-naïve).
  • Subjects receiving the following treatment for Crohn's disease:
  • Azathioprine, 6-mercaptopurine or methotrexate within 2 weeks prior to baseline.
  • Anti-TNF? therapy within 8 weeks prior to baseline.
  • Interferon therapy within 8 weeks prior to baseline.
  • Cyclosporine, mycophenolate, or tacrolimus within 4 weeks prior to baseline.
  • Intravenous corticosteroids within 2 weeks prior to baseline.
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,   Croatia,   Czech Republic,   France,   Germany,   Greece,   Hungary,   Israel,   Japan,   Korea, Republic of,   Netherlands,   South Africa,   Spain,   Ukraine,   United States
Removed Location Countries India,   Romania,   Sweden
 
Administrative Information
NCT Number  ICMJE NCT01393626
Other Study ID Numbers  ICMJE A3921083
2011-001733-16 ( 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 March 2017

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