Study Evaluating Single Doses Of SBI-087 In Japanese Subjects With Rheumatoid Arthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2012-05-31

Brief Summary

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The purpose of this study is to evaluate the safety and tolerability of single doses of SBI-087 in Japanese subjects with rheumatoid arthritis.

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Detailed Description

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Conditions

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Arthritis, Rheumatoid

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SBI-087 0.15 mg IV

Group Type EXPERIMENTAL

SBI-087

Intervention Type DRUG

IV, Single dose

SBI-087 0.5 mg IV

Group Type EXPERIMENTAL

SBI-087

Intervention Type DRUG

IV, Single dose

SBI-087 100 mg SC

Group Type EXPERIMENTAL

SBI-087

Intervention Type DRUG

SC, Single dose

SBI-087 200 mg SC

Group Type EXPERIMENTAL

SBI-087

Intervention Type DRUG

SC, Single dose

Interventions

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SBI-087

IV, Single dose

Intervention Type DRUG

SBI-087

IV, Single dose

Intervention Type DRUG

SBI-087

SC, Single dose

Intervention Type DRUG

SBI-087

SC, Single dose

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No