The objective of this study is to investigate if low doses of prednisone MR formulation, given at night and, with active drug release at 2 am, are more effective in controlling joint stiffness, and other disease symptoms of rheumatoid arthritis than standard IR prednisone given in the morning.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
288
Participants will receive tablets containing MR prednisone (to achieve the appropriate dose of 3-10 milligrams \[mg\] prednisone per day) at bed time.
Participants will receive tablets containing IR prednisone (to achieve the appropriate dose of 3-10 mg prednisone per day) in the morning.
Participants will receive placebo matching to MR prednisone tablet at bed time.
Research Site
Aachen, Germany
Research Site
Bad Kreuznach, Germany
Relative Change From Baseline in Duration of Morning Stiffness at Week 12
Duration of morning stiffness was defined as the time elapsed (in minutes) between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. Relative (percent) change = (\[value at Week 12 minus value at Baseline\] divided by \[value at baseline\]) multiplied by 100.
Time frame: Baseline, Week 12
Relative Change From Baseline in 28-Joint Disease Activity Score (DAS28) at Week 12
DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). Total DAS28 score range from 0 to approximately 10. DAS28 less than or equal to (≤) 3.2 = low disease activity, DAS28 greater than (\>) 3.2 to 5.1 = moderate to high disease activity, and DAS28 \>5.1 = severe disease activity. Relative (percent) change = (\[value at Week 12 minus value at Baseline\] divided by \[value at baseline\]) multiplied by 100.
Time frame: Baseline, Week 12
Percentage of Participants With Recurrence of Joint Stiffness at Week 12
Participants recorded the status of recurrence of joint stiffness (Yes/No) in diary data. Percentage of participants who selected Yes for recurrence of joint stiffness, are reported.
Time frame: Week 12
Relative Change From Baseline in Pain Intensity at Week 12
Participants assessed pain intensity on a 100 millimeter (mm) visual analog scale (VAS), where 0 mm = no pain, 100 mm = worst pain. Relative (percent) change = (\[value at Week 12 minus value at Baseline\] divided by \[value at baseline\]) multiplied by 100.
Time frame: Baseline, Week 12
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Participants will receive placebo matching to IR prednisone tablet in the morning.
Research Site
Berlin, Germany
Research Site
Cologne, Germany
Research Site
Dresden, Germany
Research Site
Düsseldorf, Germany
Research Site
Erlangen, Germany
Research Site
Frankfurt am Main, Germany
Research Site
Hamburg, Germany
Research Site
Hanover, Germany
...and 14 more locations
Relative Change From Baseline in Quality of Sleep at Week 12
Participants assessed quality of sleep on a 100 mm VAS, where 0 mm = very good, 100 mm = very bad. Relative (percent) change = (\[value at Week 12 minus value at Baseline\] divided by \[value at baseline\]) multiplied by 100.
Time frame: Baseline, Week 12
Relative Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. Relative (percent) change = (\[value at Week 12 minus value at Baseline\] divided by \[value at baseline\]) multiplied by 100.
Time frame: Baseline, Week 12
Relative Change From Baseline in Short-Form 36 (SF36) Mental Component Score (MCS) at Week 12
SF-36 is a standardized survey evaluating 8 domains of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0-100 (100=highest level of mental functioning). Relative (percent) change = (\[value at Week 12 minus value at Baseline\] divided by \[value at baseline\]) multiplied by 100.
Time frame: Baseline, Week 12
Relative Change From Baseline in SF36 Physical Component Score (PCS) at Week 12
SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning). Relative (percent) change = (\[value at Week 12 minus value at Baseline\] divided by \[value at baseline\]) multiplied by 100.
Time frame: Baseline, Week 12