This study is multicenter, Ph IV, single arm, interventional study to assess relative reduction of morning stiffness of Lodotra® in Rheumatoid Arthritis patients.Study medication will start after study visit at baseline (week 0, visit 1) and follow-up visit will be after 2, 6 and 12 weeks after treatment (visit 2,3,4).
Test Treatment, Dose, and Mode of Administration: Starting dose is 10mg, and depending on the clinical symptoms and the patient's response, the initial dose can quickly be reduced to a lower maintenance dose. When changing over from the standard regimen (glucocorticoid administration in the morning) to Lodotra® administered at bedtime (at about 10 pm), the same dose (in mg prednisone equivalent) should be maintained, if the subject has taken stable dose within 30 days. Lodotra® dose cannot exceed more than 10mg. Lodotra® should be taken at bedtime (at about 10 pm), with or after the evening meal and be swallowed whole with sufficient liquid. If more than 2 - 3 hours have passed since the evening meal, it is recommended to take Lodotra® with a light meal or snack. Modified-release tablets are not to be broken, divided or chewed. Treatment procedure:At Visit 1(week 0), subjects who qualify for entry into the study will medicated to Lodotra® starting dose of 10 mg daily. (Written informed consent has to be obtained, and subjects will undergo complete evaluation for study eligibility) No dose increase will be allowed for more than 10mg
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
147
Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response
Hallym University Sacred Heart Hospital
Pyeongchon, Kyungkido, South Korea
Change From Baseline in Morning Stiffness Duration at Week 12 as Assessed by Patient Diary
Data for the duration of morning stiffness will be obtained from patient diaries. Duration of morning stiffness will be from wake-up time to time of resolution of morning stiffness. Relative reduction rate of the morning stiffness duration from baseline to Week 12 of the study drug treatment was calculated for this outcome measure.
Time frame: Baseline and 12 weeks
Change of Baseline Severity of Morning Stiffness at Week 12 Using Visual Analog Scale (VAS) Scale
The VAS is a 100 mm line ranging from 0 mm (no pain) on the left end and 100 mm (worst pain) on the right end. Subjects marked on the line to indicate their pain severity. The distance in mm was measured from the left end to the subject's marking.
Time frame: Baseline and 12 weeks
Change of Functional Disability Index of the Korea Health Assessment Questionnaire (KHAQ) From Baseline to Week 12
Change in KHAQ score from baseline to Week 12 post-treatment: KHAQ is composed of 8 functional disability indices. The scale for each index is from 0 (without any difficulty) to 3 (unable to do). Scores for each disability index were summed to obtain the total score for each subject, ranging between 0 to 24, with higher scores reflecting higher functional disability. The scores were then averaged across all subjects.
Time frame: 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.