The primary purpose of this study is to identify an appropriate dose of study medication.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
143
Change From Baseline in Disease Activity Score in 28 Joints - C-reactive Protein (DAS28-CRP) at Week 12
DAS28-CRP describes severity of rheumatoid arthritis. The components of the joint count assessment are shoulder, elbow, wrist, metacarpophalangeal joints 1 through 5, proximal interphalangeal joints 1 through 5, and the knee joints on the right and left sides, whereby the number of affected joints, tender and swollen, respectively, are counted. The formula used to calculate the score is: DAS28-CRP=0.56 \\times \\sqrt{TEN28} + 0.28 \\times \\sqrt{SW28} + 0.36 \\times \\ln(CRP+1) + 0.014 \\times SA+0.96 with: TEN28: number of joints with tenderness upon touching SW28: number of swollen joints CRP: C-reactive Protein SA: subjective assessment of disease activity by the patient during the preceding 7 days on a scale between 0 and 100 ("0":no activity, "100": highest activity possible). DAS-CRP score range is 0.49 to 9.07 A DAS-CRP value \>5.1 corresponds to a high disease activity A DAS-28 reduction by 0.6 represents a moderate improvement. A reduction \>1.2 represents a major improvement
Time frame: Baseline and Week 12
American College of Rheumatology (ACR) 20/50/70 Response Rates
The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure \[most often Health Assessment Questionnaire (HAQ)\], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).
Time frame: At week 12
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Week 12
CDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (SCJ) (0-28) and tender joint count (TJC) (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity. The CDAI has a range from 0 to 76. CDAI \<= 2.8 = Remission CDAI \> 2.8 and \<= 10 = Low Disease Activity CDAI \> 10 and \<= 22 = Moderate Disease Activity CDAI \> 22 = High Disease Activity
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Rheumatology Associates Of North Alabama, P.C.
Huntsville, Alabama, United States
Mercy Clinic Hot Springs Communities
Hot Springs, Arkansas, United States
Valerius Med Group & Res Ctr Of Greater Long Beach, Inc.
Long Beach, California, United States
Desert Medical Advances
Palm Desert, California, United States
Sarasota Arthritis Research Center
Sarasota, Florida, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States
St. Paul Rheumatology, P.A.
Eagan, Minnesota, United States
Physician Research Collaboration, Llc
Lincoln, Nebraska, United States
Albuquerque Center For Rheumatology
Albuquerque, New Mexico, United States
Albuquerque Clinical Trials
Albuquerque, New Mexico, United States
...and 45 more locations
Time frame: Baseline and week 12
Change From Baseline in Simplified Disease Activity Index (SDAI) at Week 12
SDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (0-28) and tender joint count (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity and C-reactive protein (0-10). The SDAI has a range from 0 to 86. 0.0 - 3.3 = Remission 3.4 - 11.0 = Low Activity 11.1 - 26.0 = Moderate Activity 26.1 - 86.0 = High Activity
Time frame: Baseline and week 12
Boolean Remission at Week 12
Boolean-based definition: At any time point, a patient must satisfy all of the following: TJC ≤1 (0-28) SJC ≤1 (0-28) CRP ≤1 mg/dl Patient Global Assessment ≤1 (on a 0-10 scale)
Time frame: At week 12
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 12
Patients report the amount of difficulty they have in performing 8 categories. Each category is scored on a scale ranging from 0 (performed without any difficulty) to 3 (cannot be done at all). The HAQ-DI is then calculated by summing the scores and dividing by the number of categories answered. Total score is between 0-3.0. Increasing scores indicate worse functioning with 0 indicating no functional impairment and 3 indicating complete impairment. The HAQ-DI cannot be calculated if the subject does not have scores for at least 6 categories. A response was defined as a subject with a reduction from baseline in HAQ-DI of at least 0.22.
Time frame: Baseline and Week 12
Percent of Participants With a DAS28-Erythrocyte Sedimentation Rate (ESR) <2.6
DAS28- ESR = Disease Activity Scores 28 based on erythrocyte sedimentation rate. A DAS28-ESR below 2.6 is interpreted as remission.
Time frame: At week 12
Percent of Participants With a DAS28-C Reactive Protein (CRP) <2.6
DAS28-CRP = Disease Activity Scores 28 based on C Reactive Protein. A DAS28-CRP below 2.6 is interpreted as remission.
Time frame: At week 12