A four-week, randomized, controlled, open-label trial of DR prednisone in which patients receive in period 1 one of three-night time doses of treatment (4mg, 7mg or 10mg) for two weeks followed in period 2 by treatment with 15mg IR prednisone in the morning for two weeks. Period 1 is randomized and open-label and period 2 is open label. Before enrollment and randomization patient diagnosis and responsiveness to 15mg IR prednisone in the morning is established. 45 patients will be randomized, 15 patients in each treatment arm.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
delayed release prednisone
standard prednisone
Clinical Research Site
Miami, Florida, United States
Clinical Research Site
Mineola, New York, United States
Clinical Research Site
Duncansville, Pennsylvania, United States
Clinical Research Site 2
Wyomissing, Pennsylvania, United States
Change of the severity of morning stiffness from baseline to end of study (28days)
To determine the relative reduction in the severity of morning stiffness of three night time doses (4mg, 7mg, and 10mg) of DR prednisone after 2 weeks compared to the reduction after treatment with IR prednisone15mg in the morning for 2 weeks in newly diagnosed PMR patients (with no evidence of other systemic inflammatory diseases such as RA) who are known to be responsive to standard treatment with IR prednisone15mg in the morning. This will be assessed using a 10cm Visual Analog Scale (VAS).
Time frame: Assessed daily from screening through End of Study visit, 28 days total
Relative reduction in the duration of morning stiffness (minutes)
This will be assessed via a questionnaire.
Time frame: Assessed daily from screening through End of Study visit, an average of 2 months
Relative IL-6 treatment response.
Time frame: Assessed at Baseline, Day 14, and Day 28
Changes in plasma IL-6 compared with changes in the severity of morning stiffness
Time frame: Through study completion, a total of 3 assessments over 28days
Patient reported outcomes in accordance with the OMERACT PMR objectives
Time frame: Through study completion, an average of 2 months.
Performance characteristics of additional clinical measures of disease outcome.
Additional characteristics such as pain and fatigue will be assessed using a 10cm Visual Analog Scale (VAS).
Time frame: Through study completion, an average of 2 months
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Clinical Research Site
Wyomissing, Pennsylvania, United States
Clinical Research Site
Spokane, Washington, United States