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

This study has been completed.
Sponsor:
Collaborator:
Emergent Product Development Seattle LLC
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00815906
First received: December 18, 2008
Last updated: June 15, 2012
Last verified: June 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Arthritis, Rheumatoid
 Drug: SBI-087
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of SBI-087 Administered To Japanese Subjects With Rheumatoid Arthritis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety and tolerability as determined by the number and severity of adverse events at the different dose levels [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: December 2008
Study Completion Date: May 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SBI-087 0.15 mg IV Drug: SBI-087
IV, Single dose
Experimental: SBI-087 0.5 mg IV Drug: SBI-087
IV, Single dose
Experimental: SBI-087 100 mg SC Drug: SBI-087
SC, Single dose
Experimental: SBI-087 200 mg SC Drug: SBI-087
SC, Single dose

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00815906

Locations
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, Japan
Sponsors and Collaborators
Pfizer
Emergent Product Development Seattle LLC
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00815906     History of Changes
Other Study ID Numbers: 3227K1-1001, B2261002
Study First Received: December 18, 2008
Last Updated: June 15, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013