The purpose of the study is to compare the effectiveness and safety of FKB327 in comparison to Humira® in rheumatoid arthritis patients who have inadequate disease control on methotrexate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
728
American College of Rheumatology (ACR) 20 Response Rate
The primary efficacy endpoint was the ACR20 response rate at Week 24. An ACR20 response meant that the patient achieved a 20% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below. * Acute phase reactant (CRP) * Patient global assessment of disease activity * Physician global assessment of disease activity * Patient pain scale * Disability/functional questionnaire (patient completed Health Assessment Questionnaire Disability Index \[HAQ-DI\])
Time frame: Week 24
Disease Activity Score 28 (DAS28) Based on C-reactive Protein (DAS28-CRP) Score
The DAS28-CRP assessment involved evaluating the number of tender (TJC) and swollen (SJC) joints (out of 28 specified joints), serum CRP, and patient global assessment of disease activity (VAS from 0 to 100, very well to extremely bad). The DAS28-CRP is a number on a scale from 0 to 10 indicating the current activity of the patient's RA. A higher score indicates higher disease activity.
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
ACR20 Response Rates Over Time
An ACR20 response meant that the patient achieved a 20% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below. * Acute phase reactant (CRP) * Patient global assessment of disease activity * Physician global assessment of disease activity * Patient pain scale * Disability/functional questionnaire (patient completed Health Assessment Questionnaire Disability Index \[HAQ-DI\])
Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
ACR50 Response Rates Over Time
An ACR50 response meant that the patient achieved a 50% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below. * Acute phase reactant (CRP) * Patient global assessment of disease activity * Physician global assessment of disease activity * Patient pain scale * Disability/functional questionnaire (patient completed Health AssessmentQuestionnaire Disability Index \[HAQ-DI\])
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Research Site
Peoria, Arizona, United States
Research Site
Palm Desert, California, United States
Research Site
Boca Raton, Florida, United States
Research Site
Brandon, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Miami Lakes, Florida, United States
Research Site
Sarasota, Florida, United States
Research Site
Shreveport, Louisiana, United States
Research Site
Lansing, Michigan, United States
...and 90 more locations
Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
ACR70 Response Rates Over Time
An ACR70 response meant that the patient achieved a 70% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below. * Acute phase reactant (CRP) * Patient global assessment of disease activity * Physician global assessment of disease activity * Patient pain scale * Disability/functional questionnaire (patient completed Health AssessmentQuestionnaire Disability Index \[HAQ-DI\])
Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Swollen Joint Count
Counts of swollen joints from amongst 66 selected joints performed by a trained and qualified joint assessor using standardised techniques recommended by the European League Against Rheumatism (EULAR). Joints were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66 with higher scores indicating severe disease. Swollen joint count is a value of the individual ACR core set variables.
Time frame: Baseline and Week 24
Tender Joint Count
Counts of tender joints from amongst 68 selected joints were performed by a trained and qualified joint assessor using standardised techniques recommended by the European League Against Rheumatism (EULAR). Joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68 with higher scores indicating severe disease.Tender joint count is a value of the individual ACR core set variables.
Time frame: Baseline and Week 24
Analysis of Serum C-Reactive Protein (CRP) Concentration
Analysis of serum C-Reactive Protein (CRP) concentrations for inclusion in the ACR20/50/70 and DAS28-CRP scores was performed by a central laboratory. Elevation of CRP is a nonspecific marker of inflammation. Values above 10 mg/L were considered to be abnormally high. Decrease in level of CRP indicates reduction in inflammation.
Time frame: Baseline and Week 24
Patient Assessment of Disease Activity
Patient assessment of disease activity visual analogue scale (VAS) will be assessed on 100-point scales (ranging from very well (0) to extremely bad (100)).The patient assessment of disease activity VAS will contribute to the calculation of the DAS28 score. The patient assessment of disease activity VAS will contribute to the calculation of ACR20, ACR50 and ACR70 response.
Time frame: Baseline and Week 24
Physician Assessment of Disease Activity
Physician assessment of disease activity visual analogue scale (VAS) will be assessed on 100-point scale (ranging from very low (0) to very high (100)). The physician assessment of disease activity VAS will contribute to the calculation of ACR20, ACR50 and ACR70 response.
Time frame: Baseline and Week 24
Patient's Assessment of Pain
An injection site pain visual analogue score (VAS) will be administered to the patient. To determine the extent of the pain, patients will be asked to place a small vertical mark on a horizontal scale from 0 to 100, the ends of which are labelled with the extreme responses to be measured ("No pain" at 0 and "Intolerable pain" at 100). Patient's assessment of pain is a value of the individual ACR core set variables.
Time frame: Baseline and Week 24
Health Assessment Questionnaire Disability Index (HAQ-DI)
The HAQ-DI is a 20-question, self-administered instrument that measures the patient's functional ability on a 4-level difficulty scale (0 to 3, with 0 representing normal or no difficulty and 3 representing inability to perform). Eight categories of functioning are included: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. This scale is sensitive to change and is a good predictor of future disability. HAQ-DI is a value of the individual ACR core set variables.
Time frame: Baseline and Week 24
DAS28-CRP Score Over Time
The DAS28 score is a combined index that has been developed to measure the disease activity in patients with RA and has been extensively validated for its use in clinical studies. The DAS28-CRP assessment involved evaluating the number of tender (TJC) and swollen (SJC) joints (out of 28 specified joints), serum CRP, and patient global assessment of disease activity (VAS from 0 to 100, very well to extremely bad). The individual results are summed using a formula. The DAS28 is a number on a scale from 0 to 10 indicating the current activity of the patient's RA. A higher score indicates higher disease activity.
Time frame: Baseline and Week 24
DAS28 Score Based on Erythrocyte Sedimentation Rate (DAS28-ESR)
The DAS28 score is a combined index that has been developed to measure the disease activity in patients with RA and has been extensively validated for its use in clinical studies. The DAS28-ESR assessment involved evaluating the number of tender (TJC) and swollen (SJC) joints (out of 28 specified joints), serum ESR, and patient global assessment of disease activity (VAS from 0 to 100, very well to extremely bad). The individual results are summed using a formula. The DAS28 is a number on a scale from 0 to 10 indicating the current activity of the patient's RA. A higher score indicates higher disease activity.
Time frame: Baseline, Week 12 and Week 24