B0151005 Open-Label Extension Study

NCT01345318

Last updated date
Study Location
Simon Medical Imaging
Scottsdale, Arizona, 85258, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

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

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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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
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects previously enrolled in study B0151003 and completed the blinded 84 day (12 week) induction period.

- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

- Women of childbearing potential, who have sexual intercourse with a non surgically sterilized male partner, must agree and commit to the use highly effective methods of birth control from signing of the ICD through 26 weeks after the Final Study Evaluation or for 62 weeks from the last dose of investigational product for any subject who terminates early from this study.

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


- Subjects that have completed Day 84 (Week 12) of study B0151003, and experienced
serious event(s) related to the investigational product, an unstable medical
condition, or any other reason, in the opinion of the investigator, would preclude
entry or inclusion in this study.


- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the subject
inappropriate entry into this study.


- Received any prohibited treatment during study B0151003 that, in the opinion of the
investigator, compromised the safety or efficacy of this study.

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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,
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Advanced Information
Descriptive Information
Brief Title  ICMJE B0151005 Open-Label Extension Study
Official Title  ICMJE A Multicenter Open-label Extension Study For Subjects Who Participated In Study B0151003 (Andante Ii)
Brief Summary This is a multi-center Phase 2, open label, safety extension study in subjects with moderate to severe CD who are anti-TNF inadequate responders. Subjects eligible for this study will have completed the 12-week induction period of study B0151003 and will be enrolled as either responders or non responders.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease
Intervention  ICMJE
  • Biological: PF-04236921
    Subjects entering this study will be given a 50 mg SC dose at baseline and then every 8 weeks through Week 40.
  • Biological: PF-04236921
    Dose escalation to 100 mg SC every 8 weeks will be allowed for subjects who have either not responded at Week 8 or have relapsed during the study.
Study Arms  ICMJE Experimental: Open-label Treatment
Interventions:
  • Biological: PF-04236921
  • Biological: PF-04236921
Publications * Danese S, Vermeire S, Hellstern P, Panaccione R, Rogler G, Fraser G, Kohn A, Desreumaux P, Leong RW, Comer GM, Cataldi F, Banerjee A, Maguire MK, Li C, Rath N, Beebe J, Schreiber S. Randomised trial and open-label extension study of an anti-interleukin-6 antibody in Crohn's disease (ANDANTE I and II). Gut. 2019 Jan;68(1):40-48. doi: 10.1136/gutjnl-2017-314562. Epub 2017 Dec 15.

*   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: April 25, 2016)
191
Original Estimated Enrollment  ICMJE
 (submitted: April 28, 2011)
180
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects previously enrolled in study B0151003 and completed the blinded 84 day (12 week) induction period.
  • Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  • Women of childbearing potential, who have sexual intercourse with a non surgically sterilized male partner, must agree and commit to the use highly effective methods of birth control from signing of the ICD through 26 weeks after the Final Study Evaluation or for 62 weeks from the last dose of investigational product for any subject who terminates early from this study.

Exclusion Criteria:

  • Subjects that have completed Day 84 (Week 12) of study B0151003, and experienced serious event(s) related to the investigational product, an unstable medical condition, or any other reason, in the opinion of the investigator, would preclude entry or inclusion in this study.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate entry into this study.
  • Received any prohibited treatment during study B0151003 that, in the opinion of the investigator, compromised the safety or efficacy of this study.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE Child, 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,   Belgium,   Brazil,   Canada,   Czech Republic,   Denmark,   France,   Germany,   Hungary,   Ireland,   Israel,   Italy,   New Zealand,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01345318
Other Study ID Numbers  ICMJE B0151005
2011-000722-30 ( EudraCT Number )
ANDANTE II ( Other Identifier: Alias Study 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 January 2017

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