The purpose of this new research study is to gain additional information about how safe and effective R935788 is over a longer period of time.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
624
50 mg PO BID; 100 mg PO BID; 100 mg PO QD; 150 mg tablet PO QD
Percentage of Patients Who Had at Least 1 Treatment Emergent Adverse Event in Any Category
AE = adverse event, bid = twice daily, IP = investigational product, qd = once daily, SAE = serious adverse event
Time frame: Entry in extension to end of study, up to a maximum of 5 years. (Variable by subject - median duration of 3 years)
DAS28-CRP Score
The Disease Activity Score 28 using C-Reactive Protein (DAS28-CRP) is a measure of disease activity in rheumatoid arthritis (RA) and assesses the 28 joints RA commonly affects; the score includes the number of tender and swollen joints (out of 28), CRP level (a measure of inflammation in the blood), and the patient's global assessment of health (ranging from very good to very bad). These measures are then fed into a complex mathematical formula to produce the overall DAS on a scale from 1 to 10, where scores greater than 5.1 are considered to indicate active disease, scores less than 3.2 are considered to indicate with well controlled disease, and scores less than 2.6 are considered to indicate remission. bid = twice daily, CRP = C-reactive protein, DAS28 = Disease Activity Score based on a 28 joint count, n/a = not applicable, qd = once daily
Time frame: 3 years
HAQ-DI Score
Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygeine, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability. A HAQ-DI response is a reduction from baseline in HAQ-DI greater than or equal to the minimally important difference (0.22). BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, QD = once a day.
Time frame: 3 years
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Research Site
La Jolla, California, United States
Research Site
Palm Desert, California, United States
Research Site
Palo Alto, California, United States
Research Site
San Diego, California, United States
Research Site
Santa Maria, California, United States
Research Site
Hamden, Connecticut, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Aventura, Florida, United States
Research Site
Boca Raton, Florida, United States
Research Site
Gainesville, Florida, United States
...and 66 more locations