Study Evaluating Single Doses Of SBI-087 In Japanese Subjects With Rheumatoid Arthritis
An Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of SBI-087 Administered To Japanese Subjects With Rheumatoid Arthritis
2 other identifiers
interventional
20
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Dec 2008
Typical duration for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 18, 2008
CompletedFirst Posted
Study publicly available on registry
December 31, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedAugust 14, 2024
August 1, 2024
3.3 years
December 18, 2008
August 12, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and tolerability as determined by the number and severity of adverse events at the different dose levels
12 months
Secondary Outcomes (3)
To describe the single-dose PK and PD profiles (B-cell count) after a SBI-087 administration in subjects with RA
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
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
12 month
Study Arms (4)
SBI-087 0.15 mg IV
EXPERIMENTALSBI-087 0.5 mg IV
EXPERIMENTALSBI-087 100 mg SC
EXPERIMENTALSBI-087 200 mg SC
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Emergent Product Development Seattle LLCcollaborator
Study Sites (7)
Pfizer Investigational Site
Ehime, Japan
Pfizer Investigational Site
Fukui, Japan
Pfizer Investigational Site
Kanagawa, Japan
Pfizer Investigational Site
Miyagi, Japan
Pfizer Investigational Site
Ōita, Japan
Pfizer Investigational Site
Shizuoka, Japan
Pfizer Investigational Site
Tokyo, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2008
First Posted
December 31, 2008
Study Start
December 1, 2008
Primary Completion
April 1, 2012
Study Completion
May 1, 2012
Last Updated
August 14, 2024
Record last verified: 2024-08