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

Last updated on October 4, 2018

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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Study Evaluating Single Doses Of SBI-087 In Japanese Subjects With Rheumatoid Arthritis
An Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of SBI-087 Administered To Japanese Subjects With Rheumatoid Arthritis
The purpose of this study is to evaluate the safety and tolerability of single doses of SBI-087 in Japanese subjects with rheumatoid arthritis.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Arthritis, Rheumatoid
  • Drug: SBI-087
    IV, Single dose
  • Drug: SBI-087
    SC, Single dose
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
May 2012
April 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00815906
3227K1-1001
B2261002
No
Not Provided
Not Provided
Pfizer
Pfizer
Emergent Product Development Seattle LLC
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 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 thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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