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

Back to Search
Print
Bookmark Trial

NCT01470599

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Alliance Clinical Research
Oceanside, California, 92056, United States
See other locations
Contact
1-800-718-1021
ClinicalTrials.gov_Inq[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

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).

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

Crohn's DiseaseDemonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 in Patients With Active Crohn's Disease
NCT02096861
  1. Nashville, Tennessee
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Crohn's DiseaseSafety of Celecoxib in Patients With Crohn's Disease
NCT00177866
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Crohn's DiseaseTop-down Infliximab Study in Kids With Crohn's Disease
NCT02517684
  1. Brussels,
  2. Leuven,
  3. Helsinki,
  4. Rotterdam, Zuid-Holland
  5. Amsterdam,
  6. Amsterdam,
  7. Breda,
  8. Enschede,
  9. Leiden,
  10. Nijmegen,
  11. Rotterdam,
  12. Utrecht,
  13. Zwolle,
ALL GENDERS
3 Years+
years
MULTIPLE SITES
Crohn's DiseaseB0151005 Open-Label Extension Study
NCT01345318
  1. Scottsdale, Arizona
  2. Scottsdale, Arizona
  3. Tucson, Arizona
  4. Tuscon, Arizona
  5. Lakewood, Colorado
  6. Littleton, Colorado
  7. Wheat Ridge, Colorado
  8. Wheatridge, Colorado
  9. Hamden, Connecticut
  10. Clearwater, Florida
  11. Clearwater, Florida
  12. Crystal River, Florida
  13. Inverness, Florida
  14. Inverness, Florida
  15. Sanford, Florida
  16. Decatur, Georgia
  17. Decatur, Georgia
  18. Marietta, Georgia
  19. Arlington Heights, Illinois
  20. Chicago, Illinois
  21. Evanston, Illinois
  22. Lexington, Kentucky
  23. Louisville, Kentucky
  24. Louisville, Kentucky
  25. Annapolis, Maryland
  26. Annapolis, Maryland
  27. Grand Rapids, Michigan
  28. Wyoming, Michigan
  29. Wyoming, Michigan
  30. Wyoming, Michigan
  31. Ypsilanti, Michigan
  32. New York, New York
  33. New York, New York
  34. New York, New York
  35. New York, New York
  36. New York, New York
  37. New York, New York
  38. New York, New York
  39. Oklahoma City, Oklahoma
  40. Oklahoma City, Oklahoma
  41. Oklahoma, Oklahoma
  42. Tulsa, Oklahoma
  43. Tulsa, Oklahoma
  44. Pittsburgh, Pennsylvania
  45. Pittsburgh, Pennsylvania
  46. Germantown, Tennessee
  47. Nashville, Tennessee
  48. Nashville, Tennessee
  49. Nashville, Tennessee
  50. Nashville, Tennessee
  51. Austin, Texas
  52. Austin, Texas
  53. Houston, Texas
  54. Houston, Texas
  55. Houston, Texas
  56. Houston, Texas
  57. Southlake, Texas
  58. Tyler, Texas
  59. Tyler, Texas
  60. Salt Lake City, Utah
  61. Richmond, Virginia
  62. Richmond, Virginia
  63. Concord, New South Wales
  64. Brisbane, Queensland
  65. South Brisbane, Queensland
  66. Box Hill, Victoria
  67. Clayton, Victoria
  68. Fitzroy, Victoria
  69. Bruxelles,
  70. Bruxelles,
  71. Leuven,
  72. Roeselare,
  73. Curitiba, PR
  74. Curitiba, PR
  75. Curitiba, PR
  76. Rio de Janeiro, RJ
  77. Rio de Janeiro, RJ
  78. São Paulo, SP
  79. Calgary, Alberta
  80. London, Ontario
  81. Toronto, Ontario
  82. Montreal, Quebec
  83. Hradec Kralove,
  84. Olomouc,
  85. Praha 10,
  86. Praha 4,
  87. Usti nad Labem,
  88. Aarhus C,
  89. Herlev,
  90. Hilleroed,
  91. Hvidovre,
  92. Koebenhavn NV,
  93. Koebenhavn,
  94. Koege,
  95. Paris, Cedex 12
  96. Lille Cedex,
  97. Hannover, Niedersachsen
  98. Hamburg,
  99. Kiel,
  100. Minden,
  101. Budapest,
  102. Debrecen,
  103. Szeged,
  104. Szekszard,
  105. Dublin,
  106. Dublin,
  107. Dublin,
  108. Dublin,
  109. Galway,
  110. Beith Vagan, Jerusalem
  111. Haifa,
  112. Jerusalem,
  113. Kfar Saba,
  114. Petah Tikva,
  115. Tel Aviv,
  116. Rozzano, Milano
  117. Padova,
  118. Roma,
  119. Rome,
  120. Milford, Auckland
  121. Hamilton,
  122. Zuerich,
  123. Cambridge,
  124. Glasgow,
  125. London,
  126. London,
  127. London,
ALL GENDERS
0+
years
MULTIPLE SITES
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