CE-224,535 is known to block a chemical that acts as a gateway to some of your immune cells. Blocking this gateway prevents the cells from pushing out 2 chemicals called IL-1 and IL-18 that are known to cause some of the inflammation seen in rheumatoid arthritis. It is hoped that taking this drug will reduce the symptoms of rheumatoid arthritis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
500 mg po BID
no active ingredient
Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Week 12
ACR20 response: compared to baseline, greater than or equal to (\>=) 20 percent (%) improvement in tender joint count; \>= 20% improvement in swollen joint count; and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).
Time frame: Week 12
Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Week 2, 4 and 8
ACR20 response: compared to baseline, \>=20% improvement in tender joint count; \>= 20% improvement in swollen joint count; and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).
Time frame: Week 2, 4, 8
Percentage of Participants With American College of Rheumatology 50% (ACR50) Response
ACR50 response: compared to baseline, \>=50% improvement in tender joint count; \>= 50% improvement in swollen joint count; and \>= 50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).
Time frame: Week 2, 4, 8, 12
Percentage of Participants With American College of Rheumatology 70% (ACR70) Response
ACR70 response: compared to baseline, \>=70% improvement in tender joint count; \>= 70% improvement in swollen joint count; and \>= 70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).
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Arizona Arthritis & Rheumatology Associates, P.C.
Mesa, Arizona, United States
Omega Research Consultants LLC
DeBary, Florida, United States
Florida Arthritis Center
Lake Mary, Florida, United States
Tampa Medical Group, PA
Tampa, Florida, United States
American Health Network
Avon, Indiana, United States
Best Clinical Trials, LLC (Administrative Only)
New Orleans, Louisiana, United States
George Stanley Walker, MD
New Orleans, Louisiana, United States
Majid Abdul Jawad, MD
New Orleans, Louisiana, United States
The Arthritis and Osteoporosis Center of Maryland
Frederick, Maryland, United States
University Physicians
Columbia, Missouri, United States
...and 17 more locations
Time frame: Week 2, 4, 8, 12
Number of Tender/Painful and Swollen Joints
Number of tender/painful joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.
Time frame: Baseline, Week 2, 4, 8, 12
Physician Global Assessment (PGA) of Arthritis
Physician global assessment of arthritis was measured on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), with 0 mm= very good and 100 mm= very poor. This was an evaluation based on the participant's disease signs, functional capacity and physical examination.
Time frame: Baseline, Week 2, 4, 8, 12
Patient's Global Assessment of Arthritis
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 to 100 mm VAS, with 0 mm= very well and 100 mm= very poorly.
Time frame: Baseline, Week 2, 4, 8, 12
Patient's Global Assessment of Arthritic Pain
Participants measured their pain at the time of assessment on a 0 to 100 mm VAS, with 0 mm= no pain and 100 mm= most severe pain.
Time frame: Baseline, Week 2, 4, 8, 12
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Health Assessment Questionnaire-Disability Index (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.
Time frame: Baseline, Week 2, 4, 8, 12
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])
DAS28-3 (CRP) was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (milligram per liter \[mg/L\]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) less than or equal to (\<=) 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) \<2.6 = remission.
Time frame: Baseline, Week 2, 4, 8, 12
C-Reactive Protein (CRP)
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time frame: Baseline, Week 2, 4, 8, 12
Incidence of Withdrawal Due to Lack of Efficacy
Number of participants who withrew due to lack of efficacy were reported.
Time frame: Week 2, 4, 8, 12, 14
Time to Withdrawal Due to Lack of Efficacy
Time frame: Baseline up to Week 14