Study Evaluating The Efficacy And Safety Of SBI-087 In Seropositive Subjects With Active Rheumatoid Arthritis

NCT01008852

Last updated date
Study Location
Pfizer Investigational Site
Paradise Valley, Arizona, 85253, United States
Contact
1-800-718-1021

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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Active Rheumatoid Arthritis
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

- Meets the American College of Rheumatology (ACR) 1987 revised criteria for classification of Rheumatoid Arthritis (RA) for at least 6 months prior to screening

- Active RA as defined by >= 5 swollen and >= 5 tender joints (28-joint count) and at least 1 of the following: C-reactive protein >= 10 mg/L or Erythrocyte Sedimentation Rate >= 28 mm/h

- Must be seropositive as defined by a documented history of rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti-CCP) positivity

- Must be receiving a stable route and dose of methotrexate (up to 25 mg weekly)

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


- Any significant health problem other than rheumatoid arthritis


- Any clinically significant laboratory abnormalities


- Any prior use of B cell-depleting therapy

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  2. Palm Desert, California
  3. Santa Monica, California
  4. Westlake Village, California
  5. Newark, Delaware
  6. Miami, Florida
  7. Palm Harbor, Florida
  8. Springfield, Illinois
  9. Worcester, Massachusetts
  10. Grand Rapids, Michigan
  11. Albuquerque, New Mexico
  12. Syracuse, New York
  13. Minot, North Dakota
  14. Dayton, Ohio
  15. Toledo, Ohio
  16. Tulsa, Oklahoma
  17. Charleston, South Carolina
  18. Jackson, Tennessee
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  20. Clarksburg, West Virginia
  21. Buenos Aires, C.a.b.a.
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  25. Toronto, Ontario
  26. Toronto, Ontario
  27. Pointe-Claire, Quebec
  28. Providencia, Santiago
  29. Budapest,
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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating The Efficacy And Safety Of SBI-087 In Seropositive Subjects With Active Rheumatoid Arthritis
Official Title  ICMJE Randomized, Parallel, Double-Blind, Placebo-Controlled Trial To Evaluate The Efficacy And Safety Of SBI-087 In Seropositive Subjects With Active Rheumatoid Arthritis On A Stable Background Of Methotrexate
Brief Summary This study is designed to evaluate the safety and efficacy of a dose and dosage regimen of SBI-087 in seropositive patients with active Rheumatoid Arthritis, who are on a stable dose of methotrexate.
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 Active Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: SBI-087
    200 mg SC Day 1, Placebo Day 15, Placebo Day 84 + Methotrexate
  • Drug: SBI-087
    200 mg SC Day 1, 200 mg SC Day 15, Placebo Day 84 + Methotrexate
  • Drug: SBI-087
    200 mg SC Day 1, Placebo Day 15, 200 mg SC Day 84 + Methotrexate
  • Drug: SBI-087
    200 mg SC Day 1, 200 mg SC Day 15, 200 mg SC Day 84 + Methotrexate
  • Drug: Placebo
    Placebo Day 1, Placebo Day 15, Placebo Day 84 + Methotrexate
Study Arms  ICMJE
  • Experimental: Treatment Group 1
    Intervention: Drug: SBI-087
  • Experimental: Treatment Group 2
    Intervention: Drug: SBI-087
  • Experimental: Treatment Group 3
    Intervention: Drug: SBI-087
  • Experimental: Treatment Group 4
    Intervention: Drug: SBI-087
  • Placebo Comparator: Treatment Group 5
    Intervention: Drug: Placebo
Publications * Not Provided

*   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: August 27, 2013)
210
Original Estimated Enrollment  ICMJE
 (submitted: November 5, 2009)
200
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Meets the American College of Rheumatology (ACR) 1987 revised criteria for classification of Rheumatoid Arthritis (RA) for at least 6 months prior to screening
  • Active RA as defined by >= 5 swollen and >= 5 tender joints (28-joint count) and at least 1 of the following: C-reactive protein >= 10 mg/L or Erythrocyte Sedimentation Rate >= 28 mm/h
  • Must be seropositive as defined by a documented history of rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti-CCP) positivity
  • Must be receiving a stable route and dose of methotrexate (up to 25 mg weekly)

Exclusion Criteria:

  • Any significant health problem other than rheumatoid arthritis
  • Any clinically significant laboratory abnormalities
  • Any prior use of B cell-depleting therapy
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 Argentina,   Canada,   Chile,   Hungary,   Japan,   Mexico,   Poland,   Serbia,   Spain,   United States
Removed Location Countries Greece,   Turkey
 
Administrative Information
NCT Number  ICMJE NCT01008852
Other Study ID Numbers  ICMJE 3227K1-2000
B2261003
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 Emergent Product Development Seattle LLC
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2013

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