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Study Evaluating Single Doses Of SBI-087 in 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:
NCT00641225
First received: March 18, 2008
Last updated: February 21, 2013
Last verified: February 2013
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: 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 Subjects With Rheumatoid Arthritis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of ascending single doses of SBI-087 in subjects with rheumatoid arthritis. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To provide the initial pharmacokinetics and pharmacodynamic profile of SBI-087 in subjects with rheumatoid arthritis. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: March 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
SBI-087
 Drug: SBI-087
Single IV doses of SBI-087 from 0.015 mg/kg to 2 mg/kg and Single SC doses of SBI-087 from 50 mg to 300 mg.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Man or nonlactating and nonpregnant woman, aged 18 to 70 years, inclusive, at the screening visit.
  • Must meet criteria for rheumatoid arthritis with functional class I to III.
  • Diagnosis of rheumatoid arthritis more than 6 months before study day 1 and rheumatoid arthritis onset after 16 years of age

Exclusion Criteria:

  • Any significant health problems other than rheumatoid arthritis.
  • Treatment of greater than 10 mg of prednisone per day.
  • Treatment with cyclophosphamide.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00641225

Locations
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33143
United States, North Carolina
Pfizer Investigational Site
Durham, North Carolina, United States, 27710
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75231
Canada, Alberta
Pfizer Investigational Site
Edmonton, Alberta, Canada, T6G 2B7
Canada, Ontario
Pfizer Investigational Site
Toronto, Ontario, Canada, M9L 3A2
Canada, Quebec
Pfizer Investigational Site
Montreal, Quebec, Canada, H3P 3P1
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: NCT00641225     History of Changes
Other Study ID Numbers: 3227K1-1000, B2261001
Study First Received: March 18, 2008
Last Updated: February 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Ascending Single Dose
Safety
Pharmacokinetics
Open-label

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 21, 2013