Clinical trial NCT01008852: Study Evaluating The Efficacy And Safety Of SBI-087 In Seropositive Subjects With Active Rheumatoid Arthritis
Official title: Randomized, Parallel, Double-Blind, Placebo-Controlled Trial To Evaluate The Efficacy And Safety Of SBI-087 In Seropositive Subjects With Active Rheumatoid Arthritis On A Stable Background Of Methotrexate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Active Rheumatoid Arthritis
Keywords: rheumatoid arthritis
seropositive
methotrexate
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Emergent Product Development Seattle LLC
First posted: 2009-11-06
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the safety and efficacy of a dose and dosage regimen of SBI-087 in seropositive patients with active Rheumatoid Arthritis, who are on a stable dose of methotrexate.


Eligibility criteria: Inclusion Criteria:

* Meets the American College of Rheumatology (ACR) 1987 revised criteria for classification of Rheumatoid Arthritis (RA) for at least 6 months prior to screening
* Active RA as defined by \>= 5 swollen and \>= 5 tender joints (28-joint count) and at least 1 of the following: C-reactive protein \>= 10 mg/L or Erythrocyte Sedimentation Rate \>= 28 mm/h
* Must be seropositive as defined by a documented history of rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti-CCP) positivity
* Must be receiving a stable route and dose of methotrexate (up to 25 mg weekly)

Exclusion Criteria:

* Any significant health problem other than rheumatoid arthritis
* Any clinically significant laboratory abnormalities
* Any prior use of B cell-depleting therapy

Primary outcomes:
measure: Response as measured by American College of Rheumatology criteria (ACR 20 response)
timeFrame: 16 weeks
Secondary outcomes:
measure: ACR Responses, 28 Joint Assessment, Pain Visual Analog Scale (VAS), General Health VAS, Physician and Patient Global Assessments, Morning Stiffness Duration, FACIT-Fatigue, SF-36, HAQ-DI, Hybrid Measure of ACR, ACR-N, DAS-28 and EULAR response
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Paradise Valley
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Palm Desert
country: United States
facility: Pfizer Investigational Site
state: California
city: Santa Monica
country: United States
facility: Pfizer Investigational Site
state: California
city: Westlake Village
country: United States
facility: Pfizer Investigational Site
state: California
city: Newark
country: United States
facility: Pfizer Investigational Site
state: Delaware
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Palm Harbor
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Worcester
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Grand Rapids
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Albuquerque
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: Syracuse
country: United States
facility: Pfizer Investigational Site
state: New York
city: Minot
country: United States
facility: Pfizer Investigational Site
state: North Dakota
city: Dayton
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Toledo
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Jackson
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Spokane
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Clarksburg
country: United States
facility: Pfizer Investigational Site
state: West Virginia
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
state: C.a.b.a.
city: C.a.b.a
country: Argentina
facility: Pfizer Investigational Site
city: C.a.b.a
country: Argentina
facility: Pfizer Investigational Site
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Pointe-Claire
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Providencia
country: Chile
facility: Pfizer Investigational Site
state: Santiago
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Gyula
country: Hungary
facility: Pfizer Investigational Site
city: Miskolc
country: Hungary
facility: Pfizer Investigational Site
city: Szolnok
country: Hungary
facility: Pfizer Investigational Site
city: Aichi
country: Japan
facility: Pfizer Investigational Site
city: Fukui
country: Japan
facility: Pfizer Investigational Site
city: Fukuoka
country: Japan
facility: Pfizer Investigational Site
city: Hokkaido
country: Japan
facility: Pfizer Investigational Site
city: Hyogo
country: Japan
facility: Pfizer Investigational Site
city: Kanagawa
country: Japan
facility: Pfizer Investigational Site
city: Miyagi
country: Japan
facility: Pfizer Investigational Site
city: Saitama
country: Japan
facility: Pfizer Investigational Site
city: Shizuoka
country: Japan
facility: Pfizer Investigational Site
city: Tokyo
country: Japan
facility: Pfizer Investigational Site
city: Coahulia
country: Mexico
facility: Pfizer Investigational Site
state: Torreon
city: Dzialdowo
country: Poland
facility: Pfizer Investigational Site
city: Elblag
country: Poland
facility: Pfizer Investigational Site
city: Sopot
country: Poland
facility: Pfizer Investigational Site
city: Warsawa
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Belgrade
country: Serbia
facility: Pfizer Investigational Site
city: Niska Banja
country: Serbia
facility: Pfizer Investigational Site
city: Novi Sad
country: Serbia
facility: Pfizer Investigational Site
city: A Coruña
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: