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

Last updated on November 20, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Ehime, , Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00815906
Pfizer
Completed
Study Evaluating Single Doses Of SBI-087 In Japanese Subjects With Rheumatoid Arthritis

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Descriptive Information
Brief Title  ICMJE Study Evaluating Single Doses Of SBI-087 In Japanese Subjects With Rheumatoid Arthritis
Official Title  ICMJE An Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of SBI-087 Administered To Japanese Subjects With Rheumatoid Arthritis
Brief SummaryThe purpose of this study is to evaluate the safety and tolerability of single doses of SBI-087 in Japanese subjects with rheumatoid arthritis.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Arthritis, Rheumatoid
Intervention  ICMJE
  • Drug: SBI-087
    IV, Single dose
  • Drug: SBI-087
    SC, Single dose
Study Arms  ICMJE
  • Experimental: SBI-087 0.15 mg IV
    Intervention: Drug: SBI-087
  • Experimental: SBI-087 0.5 mg IV
    Intervention: Drug: SBI-087
  • Experimental: SBI-087 100 mg SC
    Intervention: Drug: SBI-087
  • Experimental: SBI-087 200 mg SC
    Intervention: Drug: SBI-087
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 4, 2010)
20
Original Estimated Enrollment  ICMJE
 (submitted: December 30, 2008)
28
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion DateApril 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00815906
Other Study ID Numbers  ICMJE 3227K1-1001
B2261002
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Emergent Product Development Seattle LLC
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJune 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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