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

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ClinicalTrials.gov Identifier: NCT00815906
Recruitment Status : Completed
First Posted : December 31, 2008
Last Update Posted : June 18, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Drug: SBI-087 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2008
Primary Completion Date : April 2012
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Safety and tolerability as determined by the number and severity of adverse events at the different dose levels [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00815906     History of Changes
Other Study ID Numbers: 3227K1-1001
B2261002
First Posted: December 31, 2008    Key Record Dates
Last Update Posted: June 18, 2012
Last Verified: June 2012

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