This is a study evaluating a 28-day course followed by a 56-day course of itacitinib in patients with active rheumatoid arthritis (RA). The study will evaluate safety and efficacy parameters of itacitinib.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
106
Unnamed facility
Palm Desert, California, United States
Unnamed facility
Pasadena, California, United States
Unnamed facility
Lake Mary, Florida, United States
Safety and tolerability of itacitinib as assessed by the changes in frequency and severity of adverse events, ECGs, vital signs, physical examinations, and clinical laboratory evaluations.
Time frame: Approximately four months.
Preliminary efficacy as assessed by the percentage of patients achieving ACR20 improvement from baseline on the day 28 and day 84 visits.
Time frame: Approximately 84 days.
Preliminary Pharmacokinetic (PK) collections.
Plasma concentrations of itacitinib will be used to estimate peak plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC).
Time frame: Following 15 days of therapy.
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Unnamed facility
Ocala, Florida, United States
Unnamed facility
Palm Harbor, Florida, United States
Unnamed facility
Tampa, Florida, United States
Unnamed facility
Tavares, Florida, United States
Unnamed facility
Lexington, Kentucky, United States
Unnamed facility
Worcester, Massachusetts, United States
Unnamed facility
Lansing, Michigan, United States
...and 8 more locations