Clinical trial NCT00634933: Study Evaluating 2 Dosing Regimens Of TRU-015 In Rheumatoid Arthritis
Official title: A Randomized, Parallel, Double-Blind, Placebo-Controlled Dose Regimen Finding Study To Evaluate The Safety And Efficacy Of TRU-015 In Subjects With Active Seropositive Rheumatoid Arthritis On A Stable Background Of Methotrexate
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Arthritis, Rheumatoid
Keywords: active
rheumatoid
arthritis
anti CD20
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Trubion Pharmaceuticals/Emergent BioSolutions Inc.
First posted: 2008-03-13
Enrollment: 222
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 will evaluate the efficacy and safety of two dosing regimens of a compound known as TRU-015 in combination with methotrexate (MTX) in patients with active rheumatoid arthritis.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of active seropositive rheumatoid arthritis on a stable dose of methotrexate (7.5-25 mg weekly) for at least 12 weeks with or without a history of anti-TNF use.

Exclusion Criteria:

* Any prior use of rituximab or other B cell depleting agents.
* Any significant health problem other than rheumatoid arthritis
* Clinically significant laboratory abnormalities

Primary outcomes:
measure: Percentage of Participants With an American College of Rheumatology 50% (ACR 50) Response at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
timeFrame: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
measure: Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response
timeFrame: Week 2, 4, 8, 12, 16, 20, 28, 32, 36, 40, 44, 48, 52
measure: Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response
timeFrame: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
measure: Number of Tender Joints
timeFrame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
measure: Number of Swollen Joints
timeFrame: Baseline. Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
measure: Duration of Morning Stiffness
timeFrame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
measure: Visual Analogue Scale for Pain (VAS-pain)
timeFrame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
measure: Physician Global Assessment (PGA) of Disease Activity
timeFrame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
measure: Patient Global Assessment (PtGA) of Disease Activity
timeFrame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
measure: General Health Visual Analog Scale (VAS)
timeFrame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
measure: Health Assessment Questionnaire Disability Index (HAQ-DI)
timeFrame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
measure: Disease Activity Score Based on 28-joints Count (DAS28)
timeFrame: Baseline, Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
measure: 36-Item Short-Form Health Survey (SF-36)
timeFrame: Baseline, Week 12, 24, 36, 52
measure: Euro Quality of Life (EQ-5D)- Health State Profile Utility Score
timeFrame: Baseline, Week 12, 24, 36, 52
measure: Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)
timeFrame: Baseline, Week 12, 24, 36, 52
measure: Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score
timeFrame: Baseline, Week 12, 24, 36, 52
measure: Work Productivity and Activity Impairment Questionnaire: Rheumatoid Arthritis (WPAI-RA) Score
timeFrame: Baseline, Week 12, 24, 36, 52
measure: Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28
timeFrame: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Paradise Valley
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Santa Maria
country: United States
facility: Pfizer Investigational Site
state: California
city: Santa Monica
country: United States
facility: Pfizer Investigational Site
state: California
city: Daytona Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ocala
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Palm Harbor
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Worcester
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Worcester
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Grande Rapids
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Flowood
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Syracuse
country: United States
facility: Pfizer Investigational Site
state: New York
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Minot
country: United States
facility: Pfizer Investigational Site
state: North Dakota
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Mayfield Village
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Danville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: State College
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Wexford
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Wilkes Barre
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Clarksburg
country: United States
facility: Pfizer Investigational Site
state: West Virginia
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Liege
country: Belgium
facility: Pfizer Investigational Site
city: Kelowna
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Kelowna
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Sydney
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Kitchener
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Trois-Rivieres
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Saskatoon
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
city: Montpellier
country: France
facility: Pfizer Investigational Site
city: PARIS Cedex 14
country: France
facility: Pfizer Investigational Site
city: Toulouse
country: France
facility: Pfizer Investigational Site
city: Vogelsang
country: Germany
facility: Pfizer Investigational Site
state: Gommern
city: Essen
country: Germany
facility: Pfizer Investigational Site
city: Koeln
country: Germany
facility: Pfizer Investigational Site
city: Wuerzburg
country: Germany
facility: Pfizer Investigational Site
city: Wuerzburg
country: Germany
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Debrecen
country: Hungary
facility: Pfizer Investigational Site
city: Nyiregyhaza
country: Hungary
facility: Pfizer Investigational Site
city: Mexicali
country: Mexico
facility: Pfizer Investigational Site
state: Baja California/Mexico
city: Guadalajara
country: Mexico
facility: Pfizer Investigational Site
state: Jalisco
city: Guadalajara
country: Mexico
facility: Pfizer Investigational Site
state: Jalisco
city: Guadalajara
country: Mexico
facility: Pfizer Investigational Site
state: Jalisco
city: Guadalajara
country: Mexico
facility: Pfizer Investigational Site
state: Jalisco
city: Morelia
country: Mexico
facility: Pfizer Investigational Site
state: Michoacan
city: Culiacan
country: Mexico
facility: Pfizer Investigational Site
state: Sinaloa/Mexico
city: Mexico City
country: Mexico
facility: Pfizer Investigational Site
city: Leiden
country: Netherlands
facility: Pfizer Investigational Site
city: Bucuresti
country: Romania
facility: Pfizer Investigational Site
city: Bucuresti
country: Romania
facility: Pfizer Investigational Site
city: Cluj-Napoca
country: Romania
facility: Pfizer Investigational Site
city: Iasi
country: Romania
facility: Pfizer Investigational Site
city: Belgrade
country: Serbia
facility: Pfizer Investigational Site
city: Niska Banja
country: Serbia
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: