This study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of ACP-196 in subjects with Rheumatoid Arthritis on background Methotrexate.
A multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial. The on-treatment period is 4 weeks with weekly visits to the clinic, followed by a 4-week safety follow-up period after the last dose of ACP-196/placebo. The study was to evaluate the safety, PK, PD, and efficacy of ACP-196 in subjects with Rheumatoid Arthritis on background Methotrexate
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
31
Pinnacle Research Group
Anniston, Alabama, United States
Achieve Clinical Research
Birmingham, Alabama, United States
Disease Activity Score 28-CRP (DAS28-CRP) at Week 4
Disease activity score 28 - C-reactive protein (DAS28-CRP) is a score to measure disease activity in patients with rheumatoid arthritis by aggregating data of 28 joints, and is calculated by the scores on scale using the following variables: The number of swollen and tender joints, CRP level, and patient's global assessment of disease activity. The total score of the DAS28 values may range from 2.0 to 10.0 while higher values mean a higher disease activity.
Time frame: 4 weeks
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Advanced Arthritis Care and Research
Scottsdale, Arizona, United States
TriWest Research Associates, LLC
El Cajon, California, United States
Neuropsychiatric Research Center of Orange County
Orange, California, United States
Pacific Arthritis Center Medical Group
Santa Monica, California, United States
Inland Rheumatology and Osteoporosis Medical Group, Inc
Upland, California, United States
San Marcus Research Clinic, Inc.
Hialeah, Florida, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States
Suncoast Clinical Research
New Port Richey, Florida, United States
...and 7 more locations