This study will evaluate the safety and efficacy of SKI-O-703 compared with placebo, in patients with active rheumatoid arthritis (RA) who have had an inadequate response to conventional synthetic disease-modifying agents. Patients will be randomly assigned to one of 4 groups and will receive one of three doses of SKI-O-703 or placebo, administered orally twice daily for 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
163
Change in Disease Activity Score
Mean change from baseline in disease activity score for 28 joints (DAS28) using hsCRP (high sensitivity C-reactive protein). Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), and high sensitivity C-reactive protein (hsCRP) (milligrams per liter). DAS28 was calculated using following formula: DAS28-CRP=0.56\*square root (sqrt)(TJC28)+0.28\*sqrt(SJC28)+0.36\*natural log(hsCRP+1)\*1.10+1.15. High DAS28-hsCRP value indicates more severe disease activity, by value of \>5.1 indicating relatively high disease activity, whereas value of \<3.2 indicating achieved lower disease activity (no theoretical full range available).
Time frame: Baseline and Week 12
• Percentage of Patients With ACR20 (American College of Rheumatology 20) Score
ACR20 score is the percentage of patients showing ≥20% improvement from baseline in tender joint count (68 joint counts), ≥20% improvement in swollen joint count (66 joint counts), and ≥20% improvement in at least 3 of the following: patient's global assessment of arthritis pain; patient's global assessment of disease activity; physician's global assessment of disease activity; health assessment questionnaire-disability index (HAQ-DI); hsCRP (high sensitivity C-reactive protein)
Time frame: Baseline and Weeks 2, 4 8 and 12
• Percentage of Patients With ACR50 (American College of Rheumatology 50) Score
ACR50 score is the percentage of patients showing ≥50% improvement from baseline in tender joint count (68 joint counts), ≥50% improvement in swollen joint count (66 joint counts), and ≥50% improvement in at least 3 of the following: patient's global assessment of arthritis pain; patient's global assessment of disease activity; physician's global assessment of disease activity; health assessment questionnaire-disability index (HAQ-DI); hsCRP (high sensitivity C-reactive protein)
Time frame: Baseline and Weeks 2, 4 8 and 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Oscotec Investigational Site (Site 3110)
Beverly Hills, California, United States
Oscotec Investigational Site (Site 3105)
Upland, California, United States
Oscotec Investigational (Site 3104)
Miami Lakes, Florida, United States
Oscotec Investigational Site (Site 3112)
Tampa, Florida, United States
Oscotec Investigational Site (Site 3108)
Lexington, Kentucky, United States
Oscotec Investigational Site (Site 3102)
Oklahoma City, Oklahoma, United States
Oscotec Investigational Site (Site 3107)
Duncansville, Pennsylvania, United States
Oscotec Investigational Site (3106)
Carrollton, Texas, United States
Oscotec Investigational Site (Site 3111)
Houston, Texas, United States
Oscotec Investigational Site (Site 3109)
Mesquite, Texas, United States
...and 30 more locations
• Percentage of Patients With ACR70 (American College of Rheumatology 70) Score
ACR70 score is the percentage of patients showing ≥70% improvement from baseline in tender joint count (68 joint counts), ≥70% improvement in swollen joint count (66 joint counts), and ≥70% improvement in at least 3 of the following: patient's global assessment of arthritis pain; patient's global assessment of disease activity; physician's global assessment of disease activity; health assessment questionnaire-disability index (HAQ-DI); hsCRP (high sensitivity C-reactive protein)
Time frame: Baseline and Weeks 2, 4 8 and 12
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Change from baseline measured by disability index The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a subject-reported questionnaire that is commonly used to measure the disease associated disability. It consists of 8 sections which are dressing or grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate HAQ-DI scores, ranging from 0 (no disability) to 3 (worst disability), higher score showing more disability. A decrease in HAQ-DI score indicated an improvement in the participant's condition.
Time frame: Baseline and Weeks 2, 4 8 and 12
Adverse Events (AEs)
Time frame: Up to Week 16
Serious Adverse Events (SAEs)
Time frame: Up to Week 16