Clinical trial NCT00808210: A Study to Evaluate Ocrelizumab in Combination With Methotrexate Compared With Infliximab Plus Methotrexate in Patients With Active Rheumatoid Arthritis Currently Responding Inadequately to Etanercept or Adalimumab
Official title: A PHASE II RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRELIZUMAB IN COMBINATION WITH METHOTREXATE, COMPARED TO INFLIXIMAB PLUS METHOTREXATE IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS CURRENTLY RESPONDING INADEQUATELY TO ETANERCEPT OR ADALIMUMAB
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: RA
Arthritis
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2008-12-15
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase II, randomized, active-controlled, double-blind, double-dummy, parallel-group, multicenter study in the United States enrolling patients with active RA. The study will enroll approximately 290 patients at approximately 130 sites.


Eligibility criteria: Inclusion Criteria:

* Age \>= 18 years
* Current treatment for RA on an outpatient basis
* Active disease
* Currently receiving 50 mg etanercept subcutaneously (SC) every week or 40 mg adalimumab SC every other week.
* Considered by Investigator to be a primary non-responder to their first anti-TNFÎ± treatment for efficacy reasons

Exclusion Criteria:

* Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA
* History of, or current, inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or other systemic autoimmune disorder (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease or other overlap syndrome)
* Previous treatment with a any biologic therapy for RA (including investigational products with the exception of etanercept or adalimumab
* Treatment with more than one prior anti-TNFÎ± therapy

Primary outcomes:
measure: Change From Baseline in DAS28(ESR) at Week 20
timeFrame: Week 20
Secondary outcomes:
measure: Percentage of Participants With Clinical Response of 20% According to ACR Criteria
timeFrame: Baseline up to 30 months
measure: Percentage of Participants With Clinical Response of 50% According to ACR Criteria
timeFrame: Baseline up to 30 months
measure: Percentage of Participants With Clinical Response of 70% According to ACR Criteria
timeFrame: Baseline up to 30 months
measure: European League Against Rheumatism (EULAR) Response Rates
timeFrame: Baseline up to 30 months
measure: Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
timeFrame: Baseline up to 30 months
measure: Change in Fatigue Visual Analog Scale Score (VAS)
timeFrame: Baseline up to 30 months
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Baseline up to 30 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Rheumatology Associates
state: Alabama
city: Jonesboro
country: United States
facility: NEA Baptist Clinic
state: Arkansas
city: Murrieta
country: United States
facility: Dr. Brigid Freyne, MD
state: California
city: Whittier
country: United States
facility: Agilence Arthritis and Osteoporosis Medical Center, Inc.
state: California
city: Colorado Springs
country: United States
facility: Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs
state: Colorado
city: Boca Raton
country: United States
facility: RASF-Clinical Research Center
state: Florida
city: Dunedin
country: United States
facility: Robert W. Levin MD - PP
state: Florida
city: Jupiter
country: United States
facility: Science and Research Institute, Inc.
state: Florida
city: Orlando
country: United States
facility: Rheumatology Associates of Central Florida
state: Florida
city: Sarasota
country: United States
facility: Lovelace Scientific Resources
state: Florida
city: Macon
country: United States
facility: Arthritis Res & Treatment
state: Georgia
city: Rome
country: United States
facility: Harbin Clinic
state: Georgia
city: Idaho Falls
country: United States
facility: Institute of Arthritis Research
state: Idaho
city: Morton Grove
country: United States
facility: Illinois Bone & Joint Inst.
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Bowling Green
country: United States
facility: Graves Gilbert Clinic
state: Kentucky
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Flint
country: United States
facility: Hurley Medical Center
state: Michigan
city: Kalamazoo
country: United States
facility: Rheumatology, P.C.; Medical Arts Building
state: Michigan
city: Lansing
country: United States
facility: Fiechtner Research Inc
state: Michigan
city: Saint Clair Shores
country: United States
facility: Shores Rheumatology
state: Michigan
city: Flowood
country: United States
facility: Jackson Arthritis Clinic
state: Mississippi
city: Jackson
country: United States
facility: Arthritis Associates of Mississippi
state: Mississippi
city: Florissant
country: United States
facility: Private Practice - Rosenberg
state: Missouri
city: Saint Louis
country: United States
facility: Clayton Medical Research
state: Missouri
city: Billings
country: United States
facility: Billings Clinic; Research Center
state: Montana
city: Billings
country: United States
facility: Billings Clinic
state: Montana
city: Omaha
country: United States
facility: Westroads Medical Group
state: Nebraska
city: Reno
country: United States
facility: Arthritis Center of Reno
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center, Rheumatology 5C
state: New Hampshire
city: Binghamton
country: United States
facility: Regional Clinical Research
state: New York
city: Brooklyn
country: United States
facility: Arthritis & Osteoporosis Center
state: New York
city: Olean
country: United States
facility: Southern Tier Arthritis & Rheumatism
state: New York
city: Orchard Park
country: United States
facility: Buffalo Rheumatology Associates
state: New York
city: Durham
country: United States
facility: Barada,Harrell,Toohey&Bellhorn
state: North Carolina
city: Greenville
country: United States
facility: Physicians East Pa
state: North Carolina
city: Columbus
country: United States
facility: Ohio State Univ Med Center
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Medical Research Foundation
state: Oklahoma
city: Tulsa
country: United States
facility: Healthcare Research Consultants
state: Oklahoma
city: Portland
country: United States
facility: Providence Arthritis Center
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Physicians Group
state: Pennsylvania
city: Erie
country: United States
facility: Arthritis Associates
state: Pennsylvania
city: Columbia
country: United States
facility: Columbia Arthritis Center (Partnership Practice)
state: South Carolina
city: Greenville
country: United States
facility: Piedmont Arthritis Clinic
state: South Carolina
city: Myrtle Beach
country: United States
facility: South Carolina Research Center
state: South Carolina
city: Hixson
country: United States
facility: Arthritis Associates
state: Tennessee
city: Memphis
country: United States
facility: Ramesh Gupta - PP
state: Tennessee
city: Nashville
country: United States
facility: Ctr for Inflammatory Disease
state: Tennessee
city: Amarillo
country: United States
facility: Amarillo Center For Clinical Research
state: Texas
city: Houston
country: United States
facility: Phillip A Waller MD, PA
state: Texas
city: Mesquite
country: United States
facility: Southwest Rheumatology
state: Texas
city: San Antonio
country: United States
facility: Texas Arthritis Research Center
state: Texas
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: