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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
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
December 18, 2008
Last Updated
June 15, 2012
Sponsor
Pfizer
Collaborators
Emergent Product Development Seattle LLC
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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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