Study Evaluating Single Doses Of SBI-087 In Japanese Subjects With Rheumatoid Arthritis
Primary Purpose
Arthritis, Rheumatoid
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
SBI-087
SBI-087
SBI-087
SBI-087
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis, Rheumatoid
Eligibility Criteria
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
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
SBI-087 0.15 mg IV
SBI-087 0.5 mg IV
SBI-087 100 mg SC
SBI-087 200 mg SC
Arm Description
Outcomes
Primary Outcome Measures
Safety and tolerability as determined by the number and severity of adverse events at the different dose levels
Secondary Outcome Measures
To describe the single-dose PK and PD profiles (B-cell count) after a SBI-087 administration in subjects with RA
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
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
Full Information
NCT ID
NCT00815906
First Posted
December 18, 2008
Last Updated
June 15, 2012
Sponsor
Pfizer
Collaborators
Emergent Product Development Seattle LLC
1. Study Identification
Unique Protocol Identification Number
NCT00815906
Brief Title
Study Evaluating Single Doses Of SBI-087 In Japanese Subjects With Rheumatoid Arthritis
Official Title
An Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of SBI-087 Administered To Japanese Subjects With Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
Collaborators
Emergent Product Development Seattle LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SBI-087 0.15 mg IV
Arm Type
Experimental
Arm Title
SBI-087 0.5 mg IV
Arm Type
Experimental
Arm Title
SBI-087 100 mg SC
Arm Type
Experimental
Arm Title
SBI-087 200 mg SC
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SBI-087
Intervention Description
IV, Single dose
Intervention Type
Drug
Intervention Name(s)
SBI-087
Intervention Description
IV, Single dose
Intervention Type
Drug
Intervention Name(s)
SBI-087
Intervention Description
SC, Single dose
Intervention Type
Drug
Intervention Name(s)
SBI-087
Intervention Description
SC, Single dose
Primary Outcome Measure Information:
Title
Safety and tolerability as determined by the number and severity of adverse events at the different dose levels
Time Frame
12 months
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Ehime
Country
Japan
Facility Name
Pfizer Investigational Site
City
Fukui
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kanagawa
Country
Japan
Facility Name
Pfizer Investigational Site
City
Miyagi
Country
Japan
Facility Name
Pfizer Investigational Site
City
Oita
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shizuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3227K1-1001&StudyName=Study%20Evaluating%20Single%20Doses%20Of%20SBI-087%20In%20Japanese%20Subjects%20With%20Rheumatoid%20Arthritis
Description
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Study Evaluating Single Doses Of SBI-087 In Japanese Subjects With Rheumatoid Arthritis
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