Subcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus Erythematosus

NCT01405196

Last updated date
Study Location
Anniston Medical Clinic, PC
Anniston, Alabama, 36207, United States
Contact
1-800-718-1021

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By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Systemic Lupus Erythematosus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female subjects between ages of 18 and 75 years old at time of signing consent.

- Have a clinical diagnosis of SLE according to 1997 update on the revised 1982 American College of Rheumatology (ACR) criteria.

- Have a unequivocally positive anti-nuclear antibody (ANA) test result.

- Active disease at screening defined by both: SLEDAI-2K score greater than or equal to 6 and BILAG Level A disease in more than or equal to 1 organ system (except renal or central nervous system) or BILAG B disease in more than or equal to 2 organ systems if no level A disease in present.

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


- Any prior history of treatment with PF-04236921, or anti-IL-6 agent;


- Have received any of the following within 364 days of day 1: a biologic
investigational agent other than B cell targeted therapy; required 3 or more courses
of systemic corticosteroids for concomitant conditions; history of previously
untreated or current evidence of active or untreated latent infection with
Tuberculosis (TB), evidence of prior untreated or currently active TB by chest
radiography, residing with or frequent close contact with an individual with active
TB.

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Systemic Lupus ErythematosusSubcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus Erythematosus
NCT01405196
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  3. Birmingham, Alabama
  4. Fair Oaks, California
  5. Lakewood, California
  6. Long Beach, California
  7. Long Beach, California
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  17. Gainesville, Florida
  18. Gainesville, Florida
  19. Gainesville, Florida
  20. Gainesville, Florida
  21. Miami, Florida
  22. Orlando, Florida
  23. Ormond Beach, Florida
  24. Palm Harbor, Florida
  25. Pinellas Park, Florida
  26. Tampa, Florida
  27. Atlanta, Georgia
  28. Atlanta, Georgia
  29. Meridian, Idaho
  30. Chicago, Illinois
  31. Granger, Indiana
  32. Indianapolis, Indiana
  33. Indianapolis, Indiana
  34. Baltimore, Maryland
  35. Baltimore, Maryland
  36. Baltimore, Maryland
  37. Boston, Massachusetts
  38. Ann Arbor, Michigan
  39. Ann Arbor, Michigan
  40. Ann Arbor, Michigan
  41. Detroit, Michigan
  42. Saint Clair Shores, Michigan
  43. Las Vegas, Nevada
  44. Albuquerque, New Mexico
  45. Brooklyn, New York
  46. Manhasset, New York
  47. New York, New York
  48. Rochester, New York
  49. Chapel Hill, North Carolina
  50. Chapel Hill, North Carolina
  51. Chapel Hill, North Carolina
  52. Charlotte, North Carolina
  53. Charlotte, North Carolina
  54. Cleveland, Ohio
  55. Middleburg Heights, Ohio
  56. Oklahoma City, Oklahoma
  57. Wyomissing, Pennsylvania
  58. Charleston, South Carolina
  59. Jackson, Tennessee
  60. Jackson, Tennessee
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  62. Dallas, Texas
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  64. Houston, Texas
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  66. Seattle, Washington
  67. Tacoma, Washington
  68. Clarksburg, West Virginia
  69. La Plata, Buenos Aires
  70. Rosario, Santa FE
  71. San Miguel de Tucuman, Tucuman
  72. C.a.b.a,
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  76. Santiago, RM
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  82. Barranquilla, Atlantico
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  86. Bucaramanga, Santander
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  90. Erlangen,
  91. Frankfurt/Main,
  92. Koeln,
  93. Leipzig,
  94. Budapest,
  95. Debrecen,
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  98. Chisinau, Md-2025
  99. San Isidro, Lima
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  24. Tamarac, Florida
  25. Tampa, Florida
  26. Tampa, Florida
  27. Tampa, Florida
  28. Decatur, Georgia
  29. Marietta, Georgia
  30. Idaho Falls, Idaho
  31. Kansas City, Kansas
  32. Kansas City, Kansas
  33. Kansas City, Kansas
  34. Baton Rouge, Louisiana
  35. Brighton, Michigan
  36. Las Vegas, Nevada
  37. Brooklyn, New York
  38. Canton, New York
  39. Manhasset, New York
  40. New York, New York
  41. New York, New York
  42. Potsdam, New York
  43. Syracuse, New York
  44. Syracuse, New York
  45. Syracuse, New York
  46. Charlotte, North Carolina
  47. Oklahoma City, Oklahoma
  48. Bethlehem, Pennsylvania
  49. Jackson, Tennessee
  50. Memphis, Tennessee
  51. Austin, Texas
  52. Baytown, Texas
  53. Houston, Texas
  54. Spokane, Washington
  55. Kogarah, New South Wales
  56. Camberwell, Victoria
  57. Leuven,
  58. Plovdiv,
  59. Ruse,
  60. Sofia,
  61. Sofia,
  62. Rimouski, Quebec
  63. Trois-Rivieres, Quebec
  64. Medellin, Antioquia
  65. Barranquilla, Atlantico
  66. Bogotá, Cundinamarca
  67. Bucaramanga, Santander
  68. Praha 2,
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  70. Paris,
  71. Paris,
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  73. Strasbourg,
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  78. Athens,
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  80. Budapest,
  81. Debrecen,
  82. Gyula,
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  84. Asahikawa, Hokkaido
  85. Sapporo, Hokkaido
  86. Sendai, Miyagi
  87. Sasebo, Nagasaki
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  89. Shinjuku-ku, Tokyo
  90. Chiba,
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  92. Hiroshima,
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  116. Iasi, Jud. Iasi
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Advanced Information
Descriptive Information
Brief Title  ICMJE Subcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus Erythematosus
Official Title  ICMJE A Double-blind, Randomized, Placebo-controlled, Multicenter Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Systemic Lupus Erythematosus (Sle)
Brief Summary The objective of this study is to evaluate and compare efficacy of 3 dose levels of PF-04236921 to placebo in subjects with generalized lupus using a measure called the Systemic Lupus Erythematosus (SLE) Responder Index. The study will evaluate secondary and exploratory measures as well.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Lupus Erythematosus, Systemic
Intervention  ICMJE
  • Biological: PF-04236921
    subcutaneous injection; administered at day 1, weeks 8, 16.
  • Biological: PF-04236921
    subcutaneous injection; administered at day 1, weeks 8, 16
Study Arms  ICMJE
  • 10 mg of PF-04236921
    Intervention: Biological: PF-04236921
  • 50 mg of PF-04236921
    Intervention: Biological: PF-04236921
  • 200 mg of PF-04236921
    Intervention: Biological: PF-04236921
  • Placebo
    Intervention: Biological: PF-04236921
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: April 11, 2014)
183
Original Estimated Enrollment  ICMJE
 (submitted: July 27, 2011)
180
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female subjects between ages of 18 and 75 years old at time of signing consent.
  • Have a clinical diagnosis of SLE according to 1997 update on the revised 1982 American College of Rheumatology (ACR) criteria.
  • Have a unequivocally positive anti-nuclear antibody (ANA) test result.
  • Active disease at screening defined by both: SLEDAI-2K score greater than or equal to 6 and BILAG Level A disease in more than or equal to 1 organ system (except renal or central nervous system) or BILAG B disease in more than or equal to 2 organ systems if no level A disease in present.

Exclusion Criteria:

  • Any prior history of treatment with PF-04236921, or anti-IL-6 agent;
  • Have received any of the following within 364 days of day 1: a biologic investigational agent other than B cell targeted therapy; required 3 or more courses of systemic corticosteroids for concomitant conditions; history of previously untreated or current evidence of active or untreated latent infection with Tuberculosis (TB), evidence of prior untreated or currently active TB by chest radiography, residing with or frequent close contact with an individual with active TB.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 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 Argentina,   Chile,   Colombia,   Germany,   Hungary,   Korea, Republic of,   Moldova, Republic of,   Peru,   Poland,   Puerto Rico,   Romania,   Taiwan,   United States
Removed Location Countries Mexico
 
Administrative Information
NCT Number  ICMJE NCT01405196
Other Study ID Numbers  ICMJE B0151006
2011-000420-15 ( EudraCT Number )
BUTTERFLY ( 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 December 2017

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