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NCT00815906 Clinical Trial

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

Arthritis, Rheumatoid Clinical Trial

Official title:
An Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of SBI-087 Administered To Japanese Subjects With Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00815906
Other study ID # 3227K1-1001
Secondary ID B2261002
Status Completed
Phase Phase 1
First received December 18, 2008
Last updated June 15, 2012
Start date December 2008
Est. completion date May 2012

Study information
Verified date June 2012
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Japan: Pharmaceuticals and Medical Devices Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date May 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 70 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• SBI-087
IV, Single dose
• SBI-087
IV, Single dose
• SBI-087
SC, Single dose
• SBI-087
SC, Single dose

Locations
Country Name City State
Japan Pfizer Investigational Site Ehime
Japan Pfizer Investigational Site Fukui
Japan Pfizer Investigational Site Kanagawa
Japan Pfizer Investigational Site Miyagi
Japan Pfizer Investigational Site Oita
Japan Pfizer Investigational Site Shizuoka
Japan Pfizer Investigational Site Tokyo

Sponsors (2)
Lead Sponsor Collaborator
Pfizer Emergent Product Development Seattle LLC

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and tolerability as determined by the number and severity of adverse events at the different dose levels 12 months No
Secondary To describe the single-dose PK and PD profiles (B-cell count) after a SBI-087 administration in subjects with RA 12 months No
Secondary 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 No
Secondary 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 No
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