A Open-Label Study Of CP-690,550 As Long-Term Therapy (48 Weeks) In Subjects With Crohn's Disease

NCT01470599

Last updated date
Study Location
Alliance Clinical Research
Oceanside, California, 92056, United States
Contact
1-800-718-1021

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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
18-76 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects who complete 26-week maintenance treatment of the A3921084 study or subjects who withdraw early due to A3921084 study treatment failure (see Appendix 5).

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

- Sexually active females of childbearing potential are required to use adequate contraceptive methods during the study period and until completion of the follow-up procedures. No specific contraceptive measures are required in male subjects during study participation.

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


- Subjects who have been discontinued due to protocol violation(s) (as determined by the
Sponsor) in the A3921084 study.


- Subjects who were discontinued from the A3921084 study due to an adverse event.


- Subjects likely to require any non-elective surgery or surgery requiring overnight
stay (with the exception of minor same day outpatient procedures that will not
interfere with study drug dosing).

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Open-Label Study Of CP-690,550 As Long-Term Therapy (48 Weeks) In Subjects With Crohn's Disease
Official Title  ICMJE A Open-Label Extension Study Of CP-690,550 As Maintenance Therapy In Patients With Crohn's Disease
Brief Summary The study hypothesis is to establish the safety and tolerability of long-term open-label (OL) CP-690,550 therapy in subjects with Crohn's disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease
Intervention  ICMJE
  • Drug: CP-690,550
    ORAL TABLET, TWICE DAILY
  • Drug: CP-690,550
    ORAL TABLETS, TWICE DAILY
Study Arms  ICMJE
  • Experimental: 5mg BID
    Intervention: Drug: CP-690,550
  • Experimental: 10mg BID
    Intervention: Drug: CP-690,550
Publications * Panés J, D'Haens GR, Higgins PDR, Mele L, Moscariello M, Chan G, Wang W, Niezychowski W, Su C, Maller E. Long-term safety and tolerability of oral tofacitinib in patients with Crohn's disease: results from a phase 2, open-label, 48-week extension study. Aliment Pharmacol Ther. 2019 Feb;49(3):265-276. doi: 10.1111/apt.15072.

*   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: February 22, 2017)
150
Original Estimated Enrollment  ICMJE
 (submitted: November 9, 2011)
90
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects who complete 26-week maintenance treatment of the A3921084 study or subjects who withdraw early due to A3921084 study treatment failure (see Appendix 5).
  • Women of childbearing potential must test negative for pregnancy prior to study enrolment.
  • Sexually active females of childbearing potential are required to use adequate contraceptive methods during the study period and until completion of the follow-up procedures. No specific contraceptive measures are required in male subjects during study participation.

Exclusion Criteria:

  • Subjects who have been discontinued due to protocol violation(s) (as determined by the Sponsor) in the A3921084 study.
  • Subjects who were discontinued from the A3921084 study due to an adverse event.
  • Subjects likely to require any non-elective surgery or surgery requiring overnight stay (with the exception of minor same day outpatient procedures that will not interfere with study drug dosing).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 76 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,   Czechia,   France,   Germany,   Greece,   Hungary,   Israel,   Japan,   Korea, Republic of,   Netherlands,   South Africa,   Spain,   Ukraine,   United States
Removed Location Countries Croatia,   Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01470599
Other Study ID Numbers  ICMJE A3921086
2011-003622-27 ( 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 September 2017

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