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Trial record 1 of 1 for:    NCT00815906
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Study Evaluating Single Doses Of SBI-087 In Japanese Subjects With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT00815906
Recruitment Status : Completed
First Posted : December 31, 2008
Last Update Posted : June 18, 2012
Sponsor:
Collaborator:
Emergent Product Development Seattle LLC
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE December 18, 2008
First Posted Date  ICMJE December 31, 2008
Last Update Posted Date June 18, 2012
Study Start Date  ICMJE December 2008
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 30, 2008)
Safety and tolerability as determined by the number and severity of adverse events at the different dose levels [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2010)
  • To describe the single-dose PK and PD profiles (B-cell count) after a SBI-087 administration in subjects with RA [ Time Frame: 12 months ]
  • To evaluate the effect of a pretreatment regimen on the occurrence of systemic reactions following SC administration of 100 mg or 200 mg SBI-087 [ Time Frame: 12 month ]
  • To investigate if changes in biomarkers (eg, complement activation markers, B-cells, CRP, IgE and tryptase levels) are related to the occurrence of systemic reactions on the day of infusion or injection of SBI-087 [ Time Frame: 12 month ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 30, 2008)
Pharmacokinetics as evaluated by the levels of the drug in the blood [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating Single Doses Of SBI-087 In Japanese Subjects With Rheumatoid Arthritis
Official Title  ICMJE An Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of SBI-087 Administered To Japanese Subjects With Rheumatoid Arthritis
Brief Summary The purpose of this study is to evaluate the safety and tolerability of single doses of SBI-087 in Japanese subjects with rheumatoid arthritis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Arthritis, Rheumatoid
Intervention  ICMJE
  • Drug: SBI-087
    IV, Single dose
  • Drug: SBI-087
    SC, Single dose
Study Arms  ICMJE
  • Experimental: SBI-087 0.15 mg IV
    Intervention: Drug: SBI-087
  • Experimental: SBI-087 0.5 mg IV
    Intervention: Drug: SBI-087
  • Experimental: SBI-087 100 mg SC
    Intervention: Drug: SBI-087
  • Experimental: SBI-087 200 mg SC
    Intervention: Drug: SBI-087
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: October 4, 2010)
20
Original Estimated Enrollment  ICMJE
 (submitted: December 30, 2008)
28
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Must meet American College of Rheumatology criteria for rheumatoid arthritis with functional class I to III.
  • Rheumatoid arthritis disease onset at >16 years of age and duration of disease at least 6 months.
  • Men or women of nonchildbearing potential (WONCBP), aged 20 to 70 years, inclusive at the screening visit.

Exclusion Criteria:

  • Any significant health problems other than rheumatoid arthritis.
  • Treatment of greater than 10 mg of prednisone per day.
  • Therapy with immunosuppressants within 6 months before study day 1
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 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 Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00815906
Other Study ID Numbers  ICMJE 3227K1-1001
B2261002
Has Data Monitoring Committee No
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 Center Pfizer
PRS Account Pfizer
Verification Date June 2012

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