CClinicalTrials.gg
Sign In
CompletedNCT00815906Updated Aug 14, 2024

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

A Phase 1 interventional study of SBI-087 and SBI-087 in Arthritis, Rheumatoid, sponsored by Pfizer. Completed at 7 sites in Japan. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-08-14.

Sponsored by Pfizer · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
20 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Arthritis, Rheumatoid
03

In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 20 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    SBI-087 0.15 mg IV

    Drug: SBI-087

  • Experimental
    SBI-087 0.5 mg IV

    Drug: SBI-087

  • Experimental
    SBI-087 100 mg SC

    Drug: SBI-087

  • Experimental
    SBI-087 200 mg SC

    Drug: SBI-087

Interventions

  • DrugSBI-087

    IV, Single dose

  • DrugSBI-087

    IV, Single dose

  • DrugSBI-087

    SC, Single dose

  • DrugSBI-087

    SC, Single dose

06

What researchers measure

Primary outcomes

  1. Safety and tolerability as determined by the number and severity of adverse events at the different dose levels

    Time frame: 12 months

Secondary outcomes

  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

07

Study locations

7 sites
  • 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
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00815906
Lead sponsor
Pfizer
Collaborators
Emergent Product Development Seattle LLC
Responsible party
Sponsor
First posted
Dec 31, 2008
Start date
Dec 2008
Primary completion
Apr 2012
Completion
May 2012
Last update
Aug 14, 2024

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Arthritis→

Other studies from this sponsor

Pfizer

Start the discussion