This is a Phase II, randomized, double-blind, placebo-controlled, parallel-group, multicenter study enrolling patients with active rheumatoid arthritis (RA).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
211
Subcutaneous repeating dose
Subcutaneous repeating dose
Stable dose if not on methotrexate
Baseline change in disease activity, assessed as the Disease Activity Score (DAS28) and erythrocyte sedimentation rate, or DAS28-(4)-ESR
Time frame: Day 85
Incidence and severity of adverse events and clinical laboratory abnormalities as a measure of safety and tolerability of MLTA3698A
Time frame: Length of study (through Day 85)
ACR20 response rate (the proportion of patients in each treatment group meeting the American College of Rheumatology 20% responder criteria [ACR20] for their average response )
Time frame: Day 85
ACR50 response rate (the proportion of patients in each treatment group meeting the American College of Rheumatology 50% responder criteria [ACR50] for their average response )
Time frame: Day 85
ACR70 response rate (the proportion of patients in each treatment group meeting the American College of Rheumatology 70% responder criteria [ACR70] for their average response)
Time frame: Day 85
Tender joint count
Time frame: Day 85
Swollen joint count
Time frame: Day 85
Investigator Global Assessment of Disease Activity
Time frame: Day 85
Patient Global Assessment of Pain and Disease Activity
Time frame: Day 85
Health Assessment Questionnaire Disability Index
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Stable dose if not on leflunomide
Subcutaneous repeating dose
Unnamed facility
Anniston, Alabama, United States
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Peoria, Arizona, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Upland, California, United States
Unnamed facility
Ormond Beach, Florida, United States
Unnamed facility
Lexington, Kentucky, United States
Unnamed facility
Kalamazoo, Michigan, United States
Unnamed facility
Flowood, Mississippi, United States
Unnamed facility
Reno, Nevada, United States
...and 57 more locations
Time frame: Day 85
Patient's Global Health or Short Form Health Survey (SF-36)
Time frame: Day 85
European League Against Rheumatism response rate
Time frame: Day 85
Serum C-reactive protein levels
Time frame: Day 85
Erythrocyte sedimentation rate
Time frame: Day 85