Study of CP-690,550 Versus Placebo In Rheumatoid Arthritis Patients On Background Methotrexate With Inadequate Response To Tumor Necrosis Factor (TNF) Inhibitors

Back to Search
Print
Bookmark Trial

NCT00960440

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35294, United States
See other locations
Contact
1-800-718-1021
[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.
Arthritis, Rheumatoid
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Adults with moderate to severe rheumatoid arthritis on a stable dose of methotrexate who have inadequate response to Tumor Necrosis Factor (TNF) inhibitors.

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


- Pregnancy, severe acute or chronic medical conditions, including serious infections or
clinically significant laboratory abnormalities.

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

Arthritis, RheumatoidStudy of CE-224,535 A Twice Daily Pill To Control Rheumatoid Arthritis In Patients Who Have Not Totally Improved With Methotrexate NCT00628095
  1. Mesa, Arizona
  2. Debary, Florida
  3. Lake Mary, Florida
  4. Tampa, Florida
  5. Avon, Indiana
  6. New Orleans, Louisiana
  7. Frederick, Maryland
  8. Columbia, Missouri
  9. Columbia, Missouri
  10. Reno, Nevada
  11. Cincinnati, Ohio
  12. Spokane, Washington
  13. Providencia, Santiago, RM
  14. Ceska Lipa,
  15. Praha 2,
  16. Praha 4,
  17. Incheon,
  18. Pusan,
  19. Mexico, D.f.
  20. Krakow,
  21. Poznan,
  22. Poznan,
  23. Santiago de Compostela, A Coruña
  24. A Coruña,
  25. Madrid,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Arthritis, RheumatoidEtanercept (Enbrel) Special Investigation (Regulatory Post Marketing Commitment Plan) NCT01230177
  1. Sendai, Miyagi
ALL GENDERS
16 Years+
years
MULTIPLE SITES
Arthritis, RheumatoidStudy of CP-690,550 Versus Placebo In Rheumatoid Arthritis Patients On Background Methotrexate With Inadequate Response To Tumor Necrosis Factor (TNF) Inhibitors NCT00960440
  1. Birmingham, Alabama
  2. Los Angeles, California
  3. Los Angeles, California
  4. San Diego, California
  5. Farmington, Connecticut
  6. Trumbull, Connecticut
  7. Aventura, Florida
  8. Tampa, Florida
  9. Atlanta, Georgia
  10. Boise, Idaho
  11. Idaho Falls, Idaho
  12. Springfield, Illinois
  13. Indianapolis, Indiana
  14. New Orleans, Louisiana
  15. Portland, Maine
  16. Cumberland, Maryland
  17. Worcester, Massachusetts
  18. Flowood, Mississippi
  19. Tupelo, Mississippi
  20. Lebanon, New Hampshire
  21. Voorhees, New Jersey
  22. Rocky Mount, North Carolina
  23. Bethlehem, Pennsylvania
  24. Willow Grove, Pennsylvania
  25. Wyomissing, Pennsylvania
  26. Hixson, Tennessee
  27. Knoxville, Tennessee
  28. Nashville, Tennessee
  29. Dallas, Texas
  30. Dallas, Texas
  31. Fort Worth, Texas
  32. Houston, Texas
  33. Lubbock, Texas
  34. Vancouver, Washington
  35. Vancouver, Washington
  36. Vancouver, Washington
  37. Kogarah, New South Wales
  38. Daw Park, South Australia
  39. Heidelberg, Victoria
  40. Wien,
  41. Wien,
  42. Wien,
  43. Wien,
  44. Genk,
  45. Hasselt,
  46. Kortrijk,
  47. Liège,
  48. Goiania, GO
  49. Curitiba, PR
  50. Porto Alegre, RS
  51. Sao Paulo, SP
  52. Winnipeg, Manitoba
  53. Hamilton, Ontario
  54. Hamilton, Ontario
  55. Ottawa, Ontario
  56. Montreal, Quebec
  57. Pointe Claire, Quebec
  58. Amiens,
  59. Lyon,
  60. Orleans Cedex 1,
  61. Orleans,
  62. Paris,
  63. Paris,
  64. Berlin,
  65. Berlin,
  66. Erlangen,
  67. Frankfurt am Main,
  68. Halle,
  69. Hamburg,
  70. Koeln,
  71. Leipzig,
  72. Rheine,
  73. Wuerzburg,
  74. Croom, Co. Limerick
  75. Dublin,
  76. Firenze,
  77. Jesi,
  78. Busan,
  79. Daegu,
  80. Seoul,
  81. San Juan,
  82. Santiago de Compostela, A Coruña
  83. Merida, Badajoz
  84. Bilbao, Bizkaia
  85. Santander, Cantabria
  86. Baracaldo, Vizcaya
  87. Madrid,
  88. Valencia,
  89. Niao Sung Hsiang, Kaohsiung County
  90. Kweishan, Taoyuan County
  91. Changhua,
  92. Kaohsiung,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Arthritis, RheumatoidA 2-Year Phase 3 Study Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate NCT00847613
  1. Huntsville, Alabama
  2. Tucson, Arizona
  3. San Diego, California
  4. Santa Maria, California
  5. Colorado Springs, Colorado
  6. Gainesville, Florida
  7. Jacksonville, Florida
  8. Sarasota, Florida
  9. Tampa, Florida
  10. Zephyrhills, Florida
  11. Morton Grove, Illinois
  12. Dubuque, Iowa
  13. Lexington, Kentucky
  14. Baltimore, Maryland
  15. Wheaton, Maryland
  16. Worcester, Massachusetts
  17. Bingham Farms, Michigan
  18. Kalamazoo, Michigan
  19. Edina, Minnesota
  20. Columbia, Missouri
  21. Columbia, Missouri
  22. Lee's Summit, Missouri
  23. Omaha, Nebraska
  24. Omaha, Nebraska
  25. Albany, New York
  26. Binghamton, New York
  27. Syracuse, New York
  28. Dayton, Ohio
  29. Pittsburgh, Pennsylvania
  30. Wyomissing, Pennsylvania
  31. Greenville, South Carolina
  32. Knoxville, Tennessee
  33. Dallas, Texas
  34. Houston, Texas
  35. San Antonio, Texas
  36. Clarksburg, West Virginia
  37. Franklin, Wisconsin
  38. Maroochydore, Queensland
  39. Woodville, South Australia
  40. Malvern East, Victoria
  41. Goiania, GO
  42. Curitiba, PR
  43. Porto Alegre, Rio Grande do Sul
  44. Rio de Janeiro, RJ
  45. Porto Alegre, RS
  46. Porto Alegre, RS
  47. Sao Paulo, SP
  48. Sao Paulo, SP
  49. Plovdiv,
  50. Plovdiv,
  51. Sofia,
  52. Sofia,
  53. Edmonton, Alberta
  54. Victoria, British Columbia
  55. St. John's, Newfoundland and Labrador
  56. Hamilton, Ontario
  57. Newmarket, Ontario
  58. Toronto, Ontario
  59. Montreal, Quebec
  60. Quebec,
  61. Medellin, Antioquia
  62. Barranquilla, Atlantico
  63. Bogota, Cundinamarca
  64. Bucaramanga, Santander
  65. Brno - Zidenice,
  66. Brno,
  67. Hostivice,
  68. Pardubice,
  69. Praha 11 - Chodov,
  70. Praha 1,
  71. Praha 2,
  72. Zlin,
  73. Thessaloniki,
  74. Hyderabad, Andhra Pradesh
  75. Secunderabad, Andhra Pradesh
  76. Hyderabad, Andra Pradesh
  77. Bangalore, Karnataka
  78. Bangalore, Karnataka
  79. Mangalore, Karnataka
  80. Pune, Maharashtra
  81. Kitakyusyu, Fukuoka
  82. Higashihiroshima, Hiroshima
  83. Hitachi-shi, Ibaraki
  84. Sagamihara, Kanagawa
  85. Koushi, Kumamoto
  86. Sendai, Miyagi
  87. Ohmura, Nagasaki
  88. Sasebo, Nagasaki
  89. Ureshino-shi, Saga
  90. Kawagoe-shi, Saitama
  91. Hamamatsu, Shizuoka
  92. Bunkyo-ku, Tokyo
  93. Shinjuku-ku, Tokyo
  94. Shinjuku-ku, Tokyo,
  95. Daejeon,
  96. Incheon,
  97. Seoul,
  98. Seoul,
  99. Seoul,
  100. Seoul,
  101. Seoul,
  102. Seoul,
  103. Mexico, DF
  104. Morelia, Michoacan
  105. Warszawa,
  106. Wroclaw,
  107. Kaohsiung,
  108. Kweishan, Taoyuan County,
  109. Taichung,
  110. Tainan,
  111. Taipei,
  112. Taipei,
  113. Simferopol, Crimea
  114. Kharkiv,
  115. Kyiv,
  116. Lviv,
  117. Vinnitsa,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study of CP-690,550 Versus Placebo In Rheumatoid Arthritis Patients On Background Methotrexate With Inadequate Response To Tumor Necrosis Factor (TNF) Inhibitors
Official Title  ICMJE Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Safety And Efficacy Of 2 Doses Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate With Inadequate Response To TNF Inhibitors
Brief Summary This study will test if CP-690,550 is safe and effective in rheumatoid arthritis patients taking methotrexate who have an inadequate response to tumor necrosis factor inhibitor treatment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Arthritis, Rheumatoid
Intervention  ICMJE
  • Drug: CP-690,550
    Oral tablets administered at 5 mg BID daily for 6 months during the double-blind, placebo-controlled period.
  • Drug: CP-690,550
    Oral tablets administered at 10 mg BID daily for 6 months during the double-blind, placebo-controlled period.
  • Drug: Placebo
    Oral placebo tablets administered BID daily during the first 3 months of the double-blind, study period.
    Other Name: double-blind, placebo-controlled phase
  • Drug: CP-690,550
    Oral tablets administered at 5 mg BID daily during the second 3 months of the double-blind, study period.
    Other Name: double-blind, extension phase
  • Drug: Placebo
    Oral placebo tablets administered BID daily during the first 3 months of the double-blind, placebo-controlled period.
    Other Name: double-blind, placebo-controlled phase
  • Drug: CP-690,550
    Oral tablets administered at 10 mg BID daily during the second 3 months of the double-blind, study period.
    Other Name: double-blind, extension phase
Study Arms  ICMJE
  • Experimental: Sequence 1
    Intervention: Drug: CP-690,550
  • Experimental: Sequence 2
    Intervention: Drug: CP-690,550
  • Placebo Comparator: Sequence 3
    Interventions:
    • Drug: Placebo
    • Drug: CP-690,550
  • Placebo Comparator: Sequence 4
    Interventions:
    • Drug: Placebo
    • Drug: CP-690,550
Publications *

*   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: November 5, 2012)		399
Original Estimated Enrollment  ICMJE
 (submitted: August 14, 2009)		400
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults with moderate to severe rheumatoid arthritis on a stable dose of methotrexate who have inadequate response to Tumor Necrosis Factor (TNF) inhibitors.

Exclusion Criteria:

  • Pregnancy, severe acute or chronic medical conditions, including serious infections or clinically significant laboratory abnormalities.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (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,   Belgium,   Brazil,   Canada,   France,   Germany,   Ireland,   Italy,   Korea, Republic of,   Puerto Rico,   Spain,   Taiwan,   United States
Removed Location Countries United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT00960440
Other Study ID Numbers  ICMJE A3921032
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 November 2018

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