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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
28
Intravenous repeating dose
Oral or parenteral repeating dose
Intravenous repeating dose
Change From Baseline in DAS28(ESR) at Week 20
Time frame: Week 20
Percentage of Participants With Clinical Response of 20% According to ACR Criteria
Time frame: Baseline up to 30 months
Percentage of Participants With Clinical Response of 50% According to ACR Criteria
Time frame: Baseline up to 30 months
Percentage of Participants With Clinical Response of 70% According to ACR Criteria
Time frame: Baseline up to 30 months
European League Against Rheumatism (EULAR) Response Rates
Time frame: Baseline up to 30 months
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Time frame: Baseline up to 30 months
Change in Fatigue Visual Analog Scale Score (VAS)
Time frame: Baseline up to 30 months
Percentage of Participants With Adverse Events (AEs)
Time frame: Baseline up to 30 months
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Intravenous repeating dose
Intravenous repeating dose
Rheumatology Associates
Birmingham, Alabama, United States
NEA Baptist Clinic
Jonesboro, Arkansas, United States
Dr. Brigid Freyne, MD
Murrieta, California, United States
Agilence Arthritis and Osteoporosis Medical Center, Inc.
Whittier, California, United States
Arthritis Assoc & Osteoporosis; Ctr of Colorado Springs
Colorado Springs, Colorado, United States
RASF-Clinical Research Center
Boca Raton, Florida, United States
Robert W. Levin MD - PP
Dunedin, Florida, United States
Science and Research Institute, Inc.
Jupiter, Florida, United States
Rheumatology Associates of Central Florida
Orlando, Florida, United States
Lovelace Scientific Resources
Sarasota, Florida, United States
...and 43 more locations