Characterize Patients With Moderately Active Rheumatoid Arthritis (RA)

BP is the pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle. BP measurement is recorded by 2 numbers: systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles).

Time frame: Baseline

Population: Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants evaluable for specified category for each treatment arm, respectively.

BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m\^2).

Time frame: Baseline

Population: Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.

The 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical component score (PCS) and mental component score (MCS). Total of 3 variables were analyzed (2 composite subscales and vitality score). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).

Time frame: Baseline, Month 60

Population: Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants evaluable at each time-point for each treatment arm, respectively.

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay. Normal range of CRP is \<10 milligram/liter (mg/L). A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

Time frame: Baseline, Month 60

Population: Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants evaluable at each time-point for each treatment arm, respectively.

DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, acute phase reactants (erythrocyte sedimentation rate \[ESR, millimeters per hour\] or C-reactive protein \[CRP, milligram per liter\]) and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 \<2.6: remission, DAS28 \<=3.2: low disease activity, DAS28 \>3.2 to \<=5.1: moderate disease activity, DAS28 \>5.1: progression.

Time frame: Baseline, Month 60

Population: Analysis population included all enrolled participants with moderate RA at baseline. Here n signifies participants evaluable at each time-point for each treatment arm, respectively.

ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter/hour (mm/hr). A higher rate is consistent with inflammation.

Time frame: Baseline, Month 60

Population: Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants evaluable at each time-point for each treatment arm, respectively.

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

Time frame: Baseline, Month 60

Population: Data not analyzed due to low number of participants available for this measure in BSRBR used for analysis.

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 to 3 where 0 = least difficulty and 3 = extreme difficulty.

Time frame: Baseline, Month 60

Population: Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants evaluable at each time-point for each treatment arm, respectively.

The pain VAS is a horizontal line; 100 millimeter (mm) in length, self-administered by the participant to rate pain from 0 mm (no pain) to 100 mm (worst possible pain).Change = mean scores at observation minus mean scores at baseline.

Time frame: Baseline, Month 60

Population: Data not analyzed due to low number of participants available for this measure in BSRBR used for analysis.

Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 100 mm VAS, where 0 mm = very well and 100 mm = very poorly.

Time frame: Baseline, Month 60

Population: Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants evaluable at each time-point for each treatment arm, respectively.

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. A negative value in change from baseline indicates an improvement.

Time frame: Baseline, Month 60

Population: Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants evaluable at each time-point for each treatment arm, respectively.

Number of tender 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. A negative value in change from baseline indicates an improvement.

Time frame: Baseline, Month 60

Population: Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants evaluable at each time-point for each treatment arm, respectively.

Direct costs included: outpatient costs, physician visits, outpatient surgery, emergency room visits, visits to healthcare professionals other than physicians, medications, diagnostic and/or therapeutic procedures, medical devices, inpatient costs, admission to acute-care nonsurgical departments, admission to acute-care surgical departments, admission to extended-care facilities, and other direct costs (travel expenses, home care, home remodeling, medical devices, non-physician healthcare professionals, alternative medicine practitioner, participant time). Indirect cost (related to lost productivity through morbidity and death) included: lost productivity in employed participants (disability, sick-leaves), lost opportunities (lost productivity in family members caring for the patient, disability requiring changes to everyday activities), and lost wages.

Time frame: Baseline

Population: Results not reported as this outcome was not evaluated due to lack of availability of information on the outcome in BSRBR used for analysis.

Time frame: Baseline

Population: Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.

ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joints count (TJC); \>= 20% improvement in swollen joints count (SJC); 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: Month 60

Population: Result not reported as no participants were evaluable at this time-point.

ACR50 response: \>= 50% improvement in TJC or SJC 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 HAQ); and CRP.

Time frame: Month 60

Population: Result not reported as no participants were evaluable at this time-point.

ACR70 response: \>=70% improvement in TJC or SJC 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 HAQ); and CRP.

Time frame: Month 60

Population: Result not reported as no participants were evaluable at this time-point.

ACR criteria: 1) Morning stiffness: in and around joints, lasting at least (\>=) 1 hour; 2) Arthritis/deformity of \>=3 joint areas: presence of soft tissue swelling or fluid (not bony overgrowth alone), 14 possible areas are right/left proximal interphalangeal (PIP), metacarpophalangeal (MCP), wrist, elbow, knee, ankle, metatarsophalangeal (MTP) joints; 3) Arthritis of hand joints: \>=1 area swollen in wrist, MCP, PIP joint; 4) Symmetric arthritis: simultaneous involvement of same joint areas (as defined in 2) on both sides of body; 5): Rheumatoid nodules: subcutaneous nodules over bony prominences or extensor surfaces or in juxtaarticular regions; 6): Rheumatoid factor (RF): abnormal amounts of RF by any method for which result has been positive in \<5% of normal control participants; 7) Radiographic changes: typical of RA on posteroanterior hand and wrist radiographs, which must include erosions/unequivocal bony decalcification localized in or most marked adjacent to involved joints.

Time frame: Baseline

Population: Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.

Time frame: Baseline

Population: Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.

Comorbidities included: hypertension, moderate or severe heart failure, angina, stroke, epilepsy, asthma, chronic bronchitis/emphysema, peptic ulcer, tuberculosis, pre-existing or recent onset of central nervous system demyelinating disorders, chronic infectious disease such as chronic renal infection, chronic chest infection with bronchiectasis or sinusitis, active tuberculosis, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease, malignancy or history of malignancy, hyperthyroidism, depression and/or anxiety, recent substance abuse (drug or alcohol), human immunodeficiency virus (HIV) infection or active hepatitis B/C infection (including associated chronic active hepatitis). Participants suffering from any of the comorbidity are reported.

Time frame: Baseline

Population: Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants evaluable for specified category for each treatment arm, respectively.

Number of participants who previously received DMARDs or were currently on DMARDs at baseline is reported.

Time frame: Baseline

Population: Analysis population included all enrolled participants with moderate RA at baseline.

Participants who had prior total knee replacement, total hip replacement, total shoulder replacement, total elbow replacement, wrist/hand/ankle/foot surgery, and neck surgery are reported.

Time frame: Baseline

Population: Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.

Systemic features included sicca syndrome, serosal involvement (pleurisy/pericarditis), eye involvement, systemic vasculitis, nailfold vasculitis, pulmonary fibrosis, and others (other than those specified).

Time frame: Baseline

Population: Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants evaluable for specified category for each treatment arm, respectively.

Number of RA-related visits to doctor/healthcare professional in previous 3 months was to be reported.

Time frame: Baseline

Population: Results not reported as this outcome was not evaluated due to lack of availability of information on the outcome in BSRBR used for analysis.

Time frame: Baseline

Population: Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.

RA symptoms include joint pain, stiffness, and swelling.

Time frame: Baseline

Population: Results not reported as this outcome was not evaluated due to lack availability of information on the outcome in BSRBR used for analysis.

Disease worsening (severe RA diagnosis) was defined as DAS28 score \>5.1.

Time frame: Baseline up to Month 60

Population: Data not analyzed due to low number of participants available for this measure in BSRBR used for analysis.

Therapeutic goal achievement was based on physician's discretion.

Time frame: Baseline up to Month 60

Population: Data not analyzed due to low number of participants available for this measure in BSRBR used for analysis.

The 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical component score (PCS) and mental component score (MCS). Total of 3 variables were analyzed (2 composite subscales and vitality score). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).

Time frame: Baseline, Month 6

Population: Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants evaluable at each time-point for each treatment arm, respectively.

DAS28 calculated from the SJC and PJC using the 28 joints count, acute phase reactants (ESR, millimeters per hour or CRP, milligram per liter) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 \<2.6: remission, DAS28 \<=3.2: low disease activity, DAS28 \>3.2 to \<=5.1: moderate disease activity, DAS28 \>5.1: progression.

Time frame: Baseline, Month 6

Population: Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

Time frame: Baseline, Month 6

Population: Data not analyzed due to low number of participants available for this measure in BSRBR used for analysis.

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 to 3 where 0 = least difficulty and 3 = extreme difficulty.

Time frame: Baseline, Month 6

Population: Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.

Number of participants who died or hospitalized due to AEs is reported by each follow-up time point up to Month 60.

Time frame: Month 6, 12, 18, 24, 30, 36, 48, 60

Population: Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants evaluable for specified category for each treatment arm, respectively.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Number of participants with AEs is reported by each follow-up time point up to Month 60.

Time frame: Month 6, 12, 18, 24, 30, 36, 48, 60

Population: Analysis population included all enrolled participants with moderate RA at baseline.

Malignancy included lymphoproliferative tumors, Hodgkins lymphoma, myeloma, leukaemia, non-melanoma skin cancer, and solid tumor. Number of participants with each of these malignancies is reported by each follow-up time point up to Month 60.

Time frame: Month 6, 12, 18, 24, 30, 36, 48, 60

Population: Analysis population included all enrolled participants with moderate RA at baseline. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants evaluable for specified category for each treatment arm, respectively.