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

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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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[email protected]

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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
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  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,
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  89. Herlev,
  90. Hilleroed,
  91. Hvidovre,
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  96. Lille Cedex,
  97. Hannover, Niedersachsen
  98. Hamburg,
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  100. Minden,
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  102. Debrecen,
  103. Szeged,
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  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,
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  3. Anaheim, California
  4. Cypress, California
  5. Oceanside, California
  6. Lafayette, Colorado
  7. Clearwater, Florida
  8. Clearwater, Florida
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  10. Gainesville, Florida
  11. Gainesville, Florida
  12. Gainesville, Florida
  13. Gainsville, Florida
  14. Naples, Florida
  15. Naples, Florida
  16. Orange Park, Florida
  17. Orlando, Florida
  18. Macon, Georgia
  19. Topeka, Kansas
  20. Chevy Chase, Maryland
  21. Chevy Chase, Maryland
  22. Ann Arbor, Michigan
  23. Ann Arbor, Michigan
  24. Troy, Michigan
  25. Troy, Michigan
  26. Great Neck, New York
  27. Poughkeepsie, New York
  28. Cleveland, Ohio
  29. Cleveland, Ohio
  30. Cleveland, Ohio
  31. Mentor, Ohio
  32. Tyler, Texas
  33. Tyler, Texas
  34. Salt Lake City, Utah
  35. Norfolk, Virginia
  36. Norfolk, Virginia
  37. Washington DC, Virginia
  38. Milwaukee, Wisconsin
  39. Milwaukee, Wisconsin
  40. Wauwatosa, Wisconsin
  41. Wauwatosa, Wisconsin
  42. Kingswood, New South Wales
  43. Clayton, Victoria
  44. Melbourne,
  45. Wien,
  46. Sofia,
  47. Sofia,
  48. Victoria, British Columbia
  49. Victoria, British Columbia
  50. Victoria, British Columbia
  51. London, Ontario
  52. Montreal, Quebec
  53. Hradec Kralove,
  54. Hradec Kralove,
  55. Hradec Králové,
  56. Lille Cedex,
  57. Pessac Cedex,
  58. Berlin,
  59. Berlin,
  60. Berlin,
  61. Kiel,
  62. Ulm,
  63. Kolonaki Athens,
  64. Budapest,
  65. Budapest,
  66. Budapest,
  67. Budapest,
  68. Gyongyos,
  69. Kaposvár,
  70. Szekszard,
  71. Jerusalem,
  72. Kfar Saba,
  73. Tel -Aviv,
  74. Nishinomiya, Hyogo
  75. Sendai, Miyagi
  76. Chiba,
  77. Hokkaido,
  78. Osaka,
  79. Seoul,
  80. Seoul,
  81. Seoul,
  82. Amsterdam,
  83. Amsterdam,
  84. Cape Town, Western Cape
  85. Durban,
  86. Barcelona,
  87. Barcelona,
  88. Madrid,
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  90. Odesa,
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  5. Clearwater, Florida
  6. Gainesville, Florida
  7. Gainesville, Florida
  8. Gainesville, Florida
  9. Gainesville, Florida
  10. Naples, Florida
  11. Naples, Florida
  12. Orange Park, Florida
  13. Orlando, Florida
  14. Macon, Georgia
  15. Ann Arbor, Michigan
  16. Ann Arbor, Michigan
  17. Troy, Michigan
  18. Troy, Michigan
  19. Great Neck, New York
  20. Great Neck, New York
  21. Cleveland, Ohio
  22. Mentor, Ohio
  23. Mentor, Ohio
  24. Willoughby, Ohio
  25. Tyler, Texas
  26. Tyler, Texas
  27. Tyler, Texas
  28. Salt Lake City, Utah
  29. Norfolk, Virginia
  30. Milwaukee, Wisconsin
  31. Wauwatosa, Wisconsin
  32. Wauwatosa, Wisconsin
  33. Kingswood, New South Wales
  34. Clayton, Victoria
  35. Parkville, Victoria
  36. Wien,
  37. Sofia,
  38. Sofia,
  39. Victoria, British Columbia
  40. Victoria, British Columbia
  41. Victoria, British Columbia
  42. London, Ontario
  43. Montreal, Quebec
  44. Hradec Kralove,
  45. Hradec Kralove,
  46. Hradec Králové,
  47. Lille Cedex,
  48. Pessac Cedex,
  49. Berlin,
  50. Kiel,
  51. Ulm,
  52. Kolonaki Athens,
  53. Budapest,
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  55. Budapest,
  56. Gyongyos,
  57. Szekszard,
  58. Jerusalem,
  59. Kfar Saba,
  60. Tel Aviv,
  61. Sapporo, Hokkaido
  62. Nishinomiya, Hyogo
  63. Sendai, Miyagi
  64. Chiba,
  65. Osaka,
  66. Seoul,
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  68. Amsterdam,
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  70. Durban,
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  2. Anaheim, California
  3. Anaheim, California
  4. Oceanside, California
  5. Poway, California
  6. San Diego, California
  7. San Diego, California
  8. Lafayette, Colorado
  9. Longmont, Colorado
  10. Guilford, Connecticut
  11. Hamden, Connecticut
  12. Hamden, Connecticut
  13. Hamden, Connecticut
  14. Washington, District of Columbia
  15. Clearwater, Florida
  16. Clearwater, Florida
  17. Clearwater, Florida
  18. Crystal River, Florida
  19. Gainesville, Florida
  20. Gainesville, Florida
  21. Gainesville, Florida
  22. Gainesville, Florida
  23. Inverness, Florida
  24. Inverness, Florida
  25. Miramar, Florida
  26. Naples, Florida
  27. Naples, Florida
  28. Orange Park, Florida
  29. Orlando, Florida
  30. Zephyrhills, Florida
  31. Macon, Georgia
  32. Oak Lawn, Illinois
  33. Clive, Iowa
  34. Clive, Iowa
  35. Clive, Iowa
  36. Clive, Iowa
  37. Topeka, Kansas
  38. Topeka, Kansas
  39. Topeka, Kansas
  40. Lexington, Kentucky
  41. Chevy Chase, Maryland
  42. Chevy Chase, Maryland
  43. Ann Arbor, Michigan
  44. Ann Arbor, Michigan
  45. Chesterfield, Michigan
  46. Troy, Michigan
  47. Lebanon, New Hampshire
  48. Great Neck, New York
  49. Great Neck, New York
  50. Poughkeepsie, New York
  51. Charlotte, North Carolina
  52. Charlotte, North Carolina
  53. Beachwood, Ohio
  54. Cleveland, Ohio
  55. Cleveland, Ohio
  56. Dayton, Ohio
  57. Mentor, Ohio
  58. Mentor, Ohio
  59. Westlake, Ohio
  60. Willoughby, Ohio
  61. Lancaster, Pennsylvania
  62. Houston, Texas
  63. Tyler, Texas
  64. Salt Lake City, Utah
  65. Norfolk, Virginia
  66. Norfolk, Virginia
  67. Virginia Beach, Virginia
  68. Milwaukee, Wisconsin
  69. Milwaukee, Wisconsin
  70. Milwaukee, Wisconsin
  71. Milwaukee, Wisconsin
  72. Wauwatosa, Wisconsin
  73. Wauwatosa, Wisconsin
  74. Kingswood, New South Wales
  75. Clayton, Victoria
  76. Parkville, Victoria
  77. Wien,
  78. Sofia,
  79. Sofia,
  80. Sofia,
  81. Sofia,
  82. Calgary, Alberta
  83. Victoria, British Columbia
  84. Victoria, British Columbia
  85. Victoria, British Columbia
  86. London, Ontario
  87. Toronto, Ontario
  88. Montreal, Quebec
  89. Montreal, Quebec
  90. Montreal, Quebec
  91. Rijeka,
  92. Zagreb,
  93. Hradec Kralove,
  94. Hradec Kralove,
  95. Hradec Králové,
  96. Lille Cedex,
  97. Pessac,
  98. Reims cedex,
  99. Berlin,
  100. Berlin,
  101. Kiel,
  102. Minden,
  103. Ulm,
  104. Kolonaki Athens,
  105. Budapest,
  106. Budapest,
  107. Budapest,
  108. Budapest,
  109. Budapest,
  110. Gyongyos,
  111. Kaposvar,
  112. Szekszard,
  113. Jerusalem,
  114. Kfar-Saba,
  115. Petach Tikva,
  116. Tel Aviv,
  117. Chikushino, Fukuoka
  118. Sapporo, Hokkaido
  119. Nishinomiya, Hyogo
  120. Sendai, Miyagi
  121. Bunkyo-ku, Tokyo
  122. Shinjuku-ku, Tokyo
  123. Chiba,
  124. Osaka,
  125. Seoul,
  126. Seoul,
  127. Seoul,
  128. Amsterdam,
  129. Amsterdam,
  130. Cape Town, Western Cape
  131. Durban,
  132. Majadahonda, Madrid
  133. Barcelona,
  134. Madrid,
  135. Dnipropetrovsk,
  136. Donetsk,
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  140. Vinnitsa,
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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