The purpose of the study is to compare the safety and efficacy, with regards to the signs and symptoms, of MR prednisone (Lodotra®) versus placebo in combination with standard Disease Modifying Anti-Rheumatic Drug (DMARD) treatment in patients with active rheumatoid arthritis.
Study with completed results acquired from Horizon in 2024.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
350
1 x 5 mg daily
1x daily
ACR 20 Response Rate at Visit 4
Responders were defined as patients whose improvement from baseline to Visit 4 (Week 12) fulfilled all 3 of the following criteria: * \> 20% reduction in the tender joint count (0-28) * \> 20% reduction in the swollen joint count (0-28) * \> 20% reduction in 3 out of the 5 following additional measures: * Patient's assessment of pain * Patient's global assessment of disease activity * Physician's global assessment of disease activity * Functional Disability Index of the Health Assessment Questionnaire * C-reactive protein or erythrocyte sedimentation rate
Time frame: Week 12
Relative Reduction of Morning Stiffness
Data for the duration of morning stiffness were obtained from patient diaries. Duration of morning stiffness was the difference between the time of resolution of morning stiffness and the time of wake-up. Duration of morning stiffness is the average of the morning stiffness duration (minutes) over the last 7 days prior to visit day (including day of visit). If more than 4 assessments were missing, then the duration was set to missing. Baseline was the value recorded at Week -1 (Visit 0).
Time frame: Week 12
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Rheumatology Associates of N. AL, P.C.
Huntsville, Alabama, United States
ArthoCare, Arthritis Care & Research, P.C.
Phoenix, Arizona, United States
The National Institute of Clinical Research
Los Angeles, California, United States
University of California, Los Angeles
Los Angeles, California, United States
Blue Hill Medical Group
Pacific Palisades, California, United States
San Diego Arthritis Medical Clinic
San Diego, California, United States
Boling Clinical Trials
Upland, California, United States
Lynn Institute of the Rockies
Colorado Springs, Colorado, United States
Front Range Clinical Research
Wheat Ridge, Colorado, United States
Arthritis Center
Palm Harbor, Florida, United States
...and 42 more locations