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Retrospective database analysis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biologic |
| ||
| non-biologic DMARD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| etanercept | Biological | This is a Non-interventional study. The data is being analyzed retrospectively. The data consists of 2 cohorts; biologic and non-biologic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With American College of Rheumatology (ACR) Criteria | 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. | Baseline |
| Number of Participants With Systemic Features | Systemic features included sicca syndrome, serosal involvement (pleurisy/pericarditis), eye involvement, systemic vasculitis, nailfold vasculitis, pulmonary fibrosis, and others (other than those specified). | Baseline |
| Number of Participants With Prior Joint Replacement or Surgery | 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. | Baseline |
| Number of Participants With Chest X-Ray Prior to New Therapy | Baseline | |
| Number of Participants With Comorbidities | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | 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. | Month 6, 12, 18, 24, 30, 36, 48, 60 |
| Number of Participants With Malignancy |
Inclusion Criteria:
The Test Group will be patients with rheumatoid arthritis, newly starting therapy with etanercept (Enbrel). Inclusion criteria for the exposed cohort subjects are:
The Control Group:
Exclusion Criteria:
Per BSRBR registry since data is retropsectively being analyzed
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The BSR Biologics Register tracks the progress of patients with severe rheumatoid arthritis and other rheumatic conditions who are taking biologic therapy and those who are biologic naive.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
Not provided
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Etanercept | Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity. |
| FG001 | nbDMARDs | Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Etanercept | Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With American College of Rheumatology (ACR) Criteria | 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. | 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. | Posted | Number | participants | Baseline |
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This study was a retrospective registry analysis of de-identified participants' data and only serious adverse events were available in the registry.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Etanercept | Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | General disorders | No Coding Applied | Non-systematic Assessment |
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Since this study was a retrospective registry analysis of de-identified participants' data, only SAEs pre specified in analysis were reported with preferred terms and all other SAEs were reported under the preferred term Other Serious Event.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000068800 | Etanercept |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D007141 | Immunoglobulin Fc Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
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|
| methotrexate (MTX) | Drug | This is a Non-interventional study. The data is being analyzed retrospectively. The data consists of 2 cohorts; biologic and non-biologic |
|
|
| Baseline |
| Body Mass Index (BMI) | BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2). | Baseline |
| Blood Pressure (BP) | 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). | Baseline |
| Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) at Month 60 | 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. | Baseline, Month 60 |
| Change From Baseline in Tender Joints Count (TJC) at Month 60 | 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. | Baseline, Month 60 |
| Change From Baseline in Swollen Joints Count (SJC) at Month 60 | 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. | Baseline, Month 60 |
| Change From Baseline in C-Reactive Protein (CRP) Level at Month 60 | 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. | Baseline, Month 60 |
| Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 60 | 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. | Baseline, Month 60 |
| Change From Baseline in Patient's Global Assessment (PtGA) of Disease Activity at Month 60 | 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. | Baseline, Month 60 |
| Duration of Disease (Rheumatoid Arthritis) | Baseline |
| Time Since First Rheumatologist Visit | Baseline |
| Time Since Recalled Symptom Onset | RA symptoms include joint pain, stiffness, and swelling. | Baseline |
| Number of Participants With Previous and Current Disease Modifying Anti-Rheumatic Drugs (DMARDs) | Number of participants who previously received DMARDs or were currently on DMARDs at baseline is reported. | Baseline |
| Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Month 60 | 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. | Baseline, Month 60 |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Month 60 | 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). | Baseline, Month 60 |
| Change From Baseline in Euro Quality of Life - 5 Dimensions (EQ-5D) at Month 60 | 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. | Baseline, Month 60 |
| Time to Disease Worsening | Disease worsening (severe RA diagnosis) was defined as DAS28 score >5.1. | Baseline up to Month 60 |
| Time to Therapeutic Goal | Therapeutic goal achievement was based on physician's discretion. | Baseline up to Month 60 |
| Change From Baseline in Pain Visual Analog Scale (VAS) Score at Month 60 | 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. | Baseline, Month 60 |
| Number of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 60 | 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). | Month 60 |
| Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 60 | 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. | Month 60 |
| Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 60 | 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. | Month 60 |
| Number of Rheumatoid Arthritis (RA) Related Visits | Number of RA-related visits to doctor/healthcare professional in previous 3 months was to be reported. | Baseline |
| Direct and Indirect Cost of Rheumatoid Arthritis (RA) Treatment | 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. | 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. |
| Month 6, 12, 18, 24, 30, 36, 48, 60 |
| Number of Participants Who Died or Hospitalized Due to Adverse Events | Number of participants who died or hospitalized due to AEs is reported by each follow-up time point up to Month 60. | Month 6, 12, 18, 24, 30, 36, 48, 60 |
| Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) at Month 6 | 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. | Baseline, Month 6 |
| Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Month 6 | 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. | Baseline, Month 6 |
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Month 6 | 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). | Baseline, Month 6 |
| Change From Baseline in Euro Quality of Life - 5 Dimensions (EQ-5D) at Month 6 | 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. | Baseline, Month 6 |
| BG001 | nbDMARDs | Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Etanercept | Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity. |
| OG001 | nbDMARDs | Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity. |
|
|
|
| Primary | Number of Participants With Systemic Features | Systemic features included sicca syndrome, serosal involvement (pleurisy/pericarditis), eye involvement, systemic vasculitis, nailfold vasculitis, pulmonary fibrosis, and others (other than those specified). | 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. | Posted | Number | participants | Baseline |
|
|
|
|
| Primary | Number of Participants With Prior Joint Replacement or Surgery | 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. | 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. | Posted | Number | participants | Baseline |
|
|
|
|
| Primary | Number of Participants With Chest X-Ray Prior to New Therapy | 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. | Posted | Number | participants | Baseline |
|
|
|
|
| Primary | Number of Participants With Comorbidities | 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. | 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. | Posted | Number | participants | Baseline |
|
|
|
|
| Primary | Body Mass Index (BMI) | BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2). | 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. | Posted | Mean | Standard Error | kg/m^2 | Baseline |
|
|
|
|
| Primary | Blood Pressure (BP) | 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). | 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. | Posted | Mean | Standard Error | millimeter of mercury (mmHg) | Baseline |
|
|
|
|
| Primary | Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) at Month 60 | 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. | 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. | Posted | Mean | Standard Error | units on a scale | Baseline, Month 60 |
|
|
|
|
| Primary | Change From Baseline in Tender Joints Count (TJC) at Month 60 | 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. | 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. | Posted | Mean | Standard Error | tender joints | Baseline, Month 60 |
|
|
|
|
| Primary | Change From Baseline in Swollen Joints Count (SJC) at Month 60 | 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. | 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. | Posted | Mean | Standard Error | swollen joints | Baseline, Month 60 |
|
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| Primary | Change From Baseline in C-Reactive Protein (CRP) Level at Month 60 | 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. | 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. | Posted | Mean | Standard Error | mg/L | Baseline, Month 60 |
|
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|
|
| Primary | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 60 | 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. | 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. | Posted | Mean | Standard Error | mm/hour | Baseline, Month 60 |
|
|
|
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| Primary | Change From Baseline in Patient's Global Assessment (PtGA) of Disease Activity at Month 60 | 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. | 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. | Posted | Mean | Standard Error | mm | Baseline, Month 60 |
|
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| Primary | Duration of Disease (Rheumatoid Arthritis) | 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. | Posted | Mean | Standard Error | years | Baseline |
|
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| Primary | Time Since First Rheumatologist Visit | 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. | Posted | Mean | Standard Error | years | Baseline |
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| Primary | Time Since Recalled Symptom Onset | RA symptoms include joint pain, stiffness, and swelling. | Results not reported as this outcome was not evaluated due to lack availability of information on the outcome in BSRBR used for analysis. | Posted | Baseline |
|
|
| Primary | Number of Participants With Previous and Current Disease Modifying Anti-Rheumatic Drugs (DMARDs) | Number of participants who previously received DMARDs or were currently on DMARDs at baseline is reported. | Analysis population included all enrolled participants with moderate RA at baseline. | Posted | Number | participants | Baseline |
|
|
|
|
| Primary | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Month 60 | 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. | 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. | Posted | Mean | Standard Error | units on a scale | Baseline, Month 60 |
|
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|
|
| Primary | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Month 60 | 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). | 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. | Posted | Mean | Standard Error | units on a scale | Baseline, Month 60 |
|
|
|
|
| Primary | Change From Baseline in Euro Quality of Life - 5 Dimensions (EQ-5D) at Month 60 | 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. | Data not analyzed due to low number of participants available for this measure in BSRBR used for analysis. | Posted | Baseline, Month 60 |
|
|
| Primary | Time to Disease Worsening | Disease worsening (severe RA diagnosis) was defined as DAS28 score >5.1. | Data not analyzed due to low number of participants available for this measure in BSRBR used for analysis. | Posted | Baseline up to Month 60 |
|
|
| Primary | Time to Therapeutic Goal | Therapeutic goal achievement was based on physician's discretion. | Data not analyzed due to low number of participants available for this measure in BSRBR used for analysis. | Posted | Baseline up to Month 60 |
|
|
| Primary | Change From Baseline in Pain Visual Analog Scale (VAS) Score at Month 60 | 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. | Data not analyzed due to low number of participants available for this measure in BSRBR used for analysis. | Posted | Baseline, Month 60 |
|
|
| Primary | Number of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 60 | 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). | Result not reported as no participants were evaluable at this time-point. | Posted | Month 60 |
|
|
| Primary | Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 60 | 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. | Result not reported as no participants were evaluable at this time-point. | Posted | Month 60 |
|
|
| Primary | Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 60 | 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. | Result not reported as no participants were evaluable at this time-point. | Posted | Month 60 |
|
|
| Primary | Number of Rheumatoid Arthritis (RA) Related Visits | Number of RA-related visits to doctor/healthcare professional in previous 3 months was to be reported. | Results not reported as this outcome was not evaluated due to lack of availability of information on the outcome in BSRBR used for analysis. | Posted | Baseline |
|
|
| Primary | Direct and Indirect Cost of Rheumatoid Arthritis (RA) Treatment | 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. | Results not reported as this outcome was not evaluated due to lack of availability of information on the outcome in BSRBR used for analysis. | Posted | Baseline |
|
|
| Other Pre-specified | Number of Participants With Adverse Events (AEs) | 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. | Analysis population included all enrolled participants with moderate RA at baseline. | Posted | Number | participants | Month 6, 12, 18, 24, 30, 36, 48, 60 |
|
|
|
|
| Other Pre-specified | Number of Participants With Malignancy | 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. | 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. | Posted | Number | participants | Month 6, 12, 18, 24, 30, 36, 48, 60 |
|
|
|
|
| Other Pre-specified | Number of Participants Who Died or Hospitalized Due to Adverse Events | Number of participants who died or hospitalized due to AEs is reported by each follow-up time point up to Month 60. | 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. | Posted | Number | participants | Month 6, 12, 18, 24, 30, 36, 48, 60 |
|
|
|
|
| Other Pre-specified | Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) at Month 6 | 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. | 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. | Posted | Mean | Standard Error | units on a scale | Baseline, Month 6 |
|
|
|
|
| Other Pre-specified | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Month 6 | 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. | 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. | Posted | Mean | Standard Error | units on a scale | Baseline, Month 6 |
|
|
|
|
| Other Pre-specified | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Month 6 | 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). | 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. | Posted | Mean | Standard Error | units on a scale | Baseline, Month 6 |
|
|
|
|
| Other Pre-specified | Change From Baseline in Euro Quality of Life - 5 Dimensions (EQ-5D) at Month 6 | 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. | Data not analyzed due to low number of participants available for this measure in BSRBR used for analysis. | Posted | Baseline, Month 6 |
|
|
| 77 |
| 211 |
| 0 |
| 0 |
| EG001 | nbDMARDs | Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity. | 534 | 1,543 | 0 | 0 |
| Septicaemia | General disorders | No Coding Applied | Non-systematic Assessment |
|
| Bone/Joint Infection | General disorders | No Coding Applied | Non-systematic Assessment |
|
| Other Infection | General disorders | No Coding Applied | Non-systematic Assessment |
|
| Congestive Heart Failure | General disorders | No Coding Applied | Non-systematic Assessment |
|
| Myocardial Infarction | General disorders | No Coding Applied | Non-systematic Assessment |
|
| Other Cardiac Events | General disorders | No Coding Applied | Non-systematic Assessment |
|
| Central Demyelination | General disorders | No Coding Applied | Non-systematic Assessment |
|
| Optic Neuritis | General disorders | No Coding Applied | Non-systematic Assessment |
|
| Peripheral Neuropathy | General disorders | No Coding Applied | Non-systematic Assessment |
|
| Other CNS Events | General disorders | No Coding Applied | Non-systematic Assessment |
|
| Pancytopaenia | General disorders | No Coding Applied | Non-systematic Assessment |
|
| Leukopaenia | General disorders | No Coding Applied | Non-systematic Assessment |
|
| Other Dyscrasia | General disorders | No Coding Applied | Non-systematic Assessment |
|
| Lymphoproliferative Tumors | General disorders | No Coding Applied | Non-systematic Assessment |
|
| Hodgkin's Lymphoma | General disorders | No Coding Applied | Non-systematic Assessment |
|
| Myeloma | General disorders | No Coding Applied | Non-systematic Assessment |
|
| Leukaemia | General disorders | No Coding Applied | Non-systematic Assessment |
|
| Non-Melanoma Skin Cancer | General disorders | No Coding Applied | Non-systematic Assessment |
|
| Solid Tumor | General disorders | No Coding Applied | Non-systematic Assessment |
|
| Other Infection | General disorders | No Coding Applied | Non-systematic Assessment |
|
| Tuberculosis (TB) | General disorders | No Coding Applied | Non-systematic Assessment |
|
| Pregnancy | General disorders | No Coding Applied | Non-systematic Assessment |
|
| Other Serious Events | General disorders | No Coding Applied | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D007127 | Immunoglobulin Constant Regions |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018124 | Receptors, Tumor Necrosis Factor |
| D018121 | Receptors, Cytokine |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Eye Involvement (n= 211, 1540) |
|
| Systemic Vasculitis (n= 211, 1540) |
|
| Nailfold Vasculitis (n= 211, 1540) |
|
| Pulmonary Fibrosis (n= 211, 1540) |
|
| Other (n= 211, 1537) |
|
| Chi-squared |
| 0.024 |
| 2-Sided |
| No |
| Superiority or Other |
| Eye Involvement: p-value was calculated using chi-square test. | Chi-squared | 0.257 | 2-Sided | No | Superiority or Other |
| Systemic Vasculitis: p-value was calculated using chi-square test. | Chi-squared | 0.026 | 2-Sided | No | Superiority or Other |
| Nailfold Vasculitis: p-value was calculated using chi-square test. | Chi-squared | 0.725 | 2-Sided | No | Superiority or Other |
| Pulmonary Fibrosis: p-value was calculated using chi-square test. | Chi-squared | 0.220 | 2-Sided | No | Superiority or Other |
| Other: p-value was calculated using chi-square test. | Chi-squared | 0.620 | 2-Sided | No | Superiority or Other |
| Total Shoulder Replacement |
|
| Total Elbow Replacement |
|
| Wrist/Hand/Ankle/Foot Surgery |
|
| Neck Surgery |
|
| Chi-squared |
| <0.001 |
| 2-Sided |
| No |
| Superiority or Other |
| Total Shoulder Replacement: p-value was calculated using chi-square test. | Chi-squared | <0.001 | 2-Sided | No | Superiority or Other |
| Total Elbow Replacement: p-value was calculated using chi-square test. | Chi-squared | <0.001 | 2-Sided | No | Superiority or Other |
| Wrist/Hand/Ankle/Foot Surgery: p-value was calculated using chi-square test. | Chi-squared | 0.001 | 2-Sided | No | Superiority or Other |
| Neck Surgery: p-value was calculated using chi-square test. | Chi-squared | <0.001 | 2-Sided | No | Superiority or Other |
| Heart Attack (n= 210, 1535) |
|
| Stroke (n= 211, 1538) |
|
| Epilepsy (n= 211, 1541) |
|
| Asthma (n= 211, 1539) |
|
| Chronic Bronchitis/Emphysema (n= 211, 1537) |
|
| Peptic Ulcer (n= 208, 1537) |
|
| Liver Disease (n= 211, 1539) |
|
| Renal Disease (n= 211, 1540) |
|
| Tuberculosis (n= 207, 1538) |
|
| Demyelination (n= 210, 1536) |
|
| Diabetes (n= 211, 1539) |
|
| Hyperthyroidism (n= 211, 1535) |
|
| Depression (n= 211, 1539) |
|
| Cancer (n= 210, 1540) |
|
| 0.006 |
| 2-Sided |
| No |
| Superiority or Other |
| Heart Attack: p-value was calculated using chi-square test. | Chi-squared | 0.215 | 2-Sided | No | Superiority or Other |
| Stroke: p-value was calculated using chi-square test. | Chi-squared | 0.117 | 2-Sided | No | Superiority or Other |
| Epilepsy: p-value was calculated using chi-square test. | Chi-squared | 1.000 | 2-Sided | No | Superiority or Other |
| Asthma: p-value was calculated using chi-square test. | Chi-squared | 0.542 | 2-Sided | No | Superiority or Other |
| Chronic Bronchitis/Emphysema: p-value was calculated using chi-square test. | Chi-squared | 0.027 | 2-Sided | No | Superiority or Other |
| Peptic Ulcer: p-value was calculated using chi-square test. | Chi-squared | 0.566 | 2-Sided | No | Superiority or Other |
| Liver Disease: p-value was calculated using chi-square test. | Chi-squared | 0.003 | 2-Sided | No | Superiority or Other |
| Renal Disease: p-value was calculated using chi-square test. | Chi-squared | 0.526 | 2-Sided | No | Superiority or Other |
| Tuberculosis: p-value was calculated using chi-square test. | Chi-squared | 0.802 | 2-Sided | No | Superiority or Other |
| Demyelination: p-value was calculated using chi-square test. | Chi-squared | 1.000 | 2-Sided | No | Superiority or Other |
| Diabetes: p-value was calculated using chi-square test. | Chi-squared | 0.385 | 2-Sided | No | Superiority or Other |
| Hyperthyroidism: p-value was calculated using chi-square test. | Chi-squared | 0.048 | 2-Sided | No | Superiority or Other |
| Depression: p-value was calculated using chi-square test. | Chi-squared | 0.308 | 2-Sided | No | Superiority or Other |
| Cancer: p-value was calculated using chi-square test. | Chi-squared | 0.033 | 2-Sided | No | Superiority or Other |
| t-test, 2 sided |
| 0.369 |
| 2-Sided |
| No |
| Superiority or Other |
| Regression, Linear |
| 0.3746 |
| 2-Sided |
| No |
| Superiority or Other |
| Current DMARDs: Cyclophosphamide |
|
| Current DMARDs: Cyclosporine |
|
| Current DMARDs: Leflunomide |
|
| Current DMARDs: Sulphasalazine |
|
| Previous DMARDs: Methotrexate |
|
| Previous DMARDs: Azathioprine |
|
| Previous DMARDs: Cyclophosphamide |
|
| Previous DMARDs: Cyclosporine |
|
| Previous DMARDs: Leflunomide |
|
| Chi-squared |
| 0.313 |
| 2-Sided |
| No |
| Superiority or Other |
| Current DMARDs, Cyclophosphamide: p-value was calculated using chi-square test. | Chi-squared | 1.000 | 2-Sided | No | Superiority or Other |
| Current DMARDs, Cyclosporine: p-value was calculated using chi-square test. | Chi-squared | 0.066 | 2-Sided | No | Superiority or Other |
| Current DMARDs, Leflunomide: p-value was calculated using chi-square test. | Chi-squared | 0.099 | 2-Sided | No | Superiority or Other |
| Current DMARDs, Sulphasalazine: p-value was calculated using chi-square test. | Chi-squared | <0.001 | 2-Sided | No | Superiority or Other |
| Previous DMARDs, Methotrexate: p-value was calculated using chi-square test. | Chi-squared | <0.001 | 2-Sided | No | Superiority or Other |
| Previous DMARDs, Azathioprine: p-value was calculated using chi-square test. | Chi-squared | <0.001 | 2-Sided | No | Superiority or Other |
| Previous DMARDs, Cyclophosphamide: p-value was calculated using chi-square test. | Chi-squared | <0.001 | 2-Sided | No | Superiority or Other |
| Previous DMARDs, Cyclosporine: p-value was calculated using chi-square test. | Chi-squared | <0.001 | 2-Sided | No | Superiority or Other |
| Previous DMARDs, Leflunomide: p-value was calculated using chi-square test. | Chi-squared | <0.001 | 2-Sided | No | Superiority or Other |
| Baseline: Vitality Score (n= 186, 1272) |
|
| Change at Month 60: PCS (n= 0, 0) |
|
| Change at Month 60: MCS (n= 0, 0) |
|
| Change at Month 60: Vitality Score (n= 0, 0) |
|
| 0.886 |
| 2-Sided |
| No |
| Superiority or Other |
| Baseline Vitality Score: p-value was calculated using 2-sided t-test. | t-test, 2 sided | 0.680 | 2-Sided | No | Superiority or Other |
| Month 18 |
|
| Month 24 |
|
| Month 30 |
|
| Month 36 |
|
| Month 48 |
|
| Month 60 |
|
| 0.5103 |
| 2-Sided |
| No |
| Superiority or Other |
| Month 18: p-value was calculated using chi-square test. | Chi-squared | 0.9990 | 2-Sided | No | Superiority or Other |
| Month 24: p-value was calculated using chi-square test. | Chi-squared | 0.6495 | 2-Sided | No | Superiority or Other |
| Month 30: p-value was calculated using chi-square test. | Chi-squared | 0.3829 | 2-Sided | No | Superiority or Other |
| Month 36: p-value was calculated using chi-square test. | Chi-squared | 0.1085 | 2-Sided | No | Superiority or Other |
| Month 48: p-value was calculated using chi-square test. | Chi-squared | 0.0472 | 2-Sided | No | Superiority or Other |
| Month 60: p-value was calculated using chi-square test. | Chi-squared | 0.4804 | 2-Sided | No | Superiority or Other |
| Lymphoproliferative Tumors: Month 18 (n=146, 1350) |
|
| Lymphoproliferative Tumors: Month 24 (n=141, 1245) |
|
| Lymphoproliferative Tumors: Month 30 (n=127, 1097) |
|
| Lymphoproliferative Tumors: Month 36 (n=128, 1027) |
|
| Lymphoproliferative Tumors: Month 48 (n=114, 815) |
|
| Lymphoproliferative Tumors: Month 60 (n=108, 516) |
|
| Hodgkins Lymphoma: Month 6 (n=191, 1457) |
|
| Hodgkins Lymphoma: Month 12 (n=172, 1394) |
|
| Hodgkins Lymphoma: Month 18 (n=146, 1350) |
|
| Hodgkins Lymphoma: Month 24 (n=141, 1245) |
|
| Hodgkins Lymphoma: Month 30 (n=127, 1097) |
|
| Hodgkins Lymphoma: Month 36 (n=128, 1027) |
|
| Hodgkins Lymphoma: Month 48 (n=114, 815) |
|
| Hodgkins Lymphoma: Month 60 (n=108, 516) |
|
| Myeloma: Month 6 (n=191, 1457) |
|
| Myeloma: Month 12 (n=172, 1394) |
|
| Myeloma: Month 18 (n=146, 1350) |
|
| Myeloma: Month 24 (n=141, 1245) |
|
| Myeloma: Month 30 (n=127, 1097) |
|
| Myeloma: Month 36 (n=128, 1027) |
|
| Myeloma: Month 48 (n=114, 815) |
|
| Myeloma: Month 60 (n=108, 516) |
|
| Leukaemia: Month 6 (n=191, 1457) |
|
| Leukaemia: Month 12 (n=172, 1394) |
|
| Leukaemia: Month 18 (n=146, 1350) |
|
| Leukaemia: Month 24 (n=141, 1245) |
|
| Leukaemia: Month 30 (n=127, 1097) |
|
| Leukaemia: Month 36 (n=128, 1027) |
|
| Leukaemia: Month 48 (n=114, 815) |
|
| Leukaemia: Month 60 (n=108, 516) |
|
| Non-Melanoma Skin Cancer: Month 6 (n=191, 1457) |
|
| Non-Melanoma Skin Cancer: Month 12 (n=172, 1394) |
|
| Non-Melanoma Skin Cancer: Month 18 (n=146, 1350) |
|
| Non-Melanoma Skin Cancer: Month 24 (n=141, 1245) |
|
| Non-Melanoma Skin Cancer: Month 30 (n=127, 1097) |
|
| Non-Melanoma Skin Cancer: Month 36 (n=128, 1027) |
|
| Non-Melanoma Skin Cancer: Month 48 (n=114, 815) |
|
| Non-Melanoma Skin Cancer: Month 60 (n=108, 516) |
|
| Solid Tumor: Month 6 (n=191, 1457) |
|
| Solid Tumor: Month 12 (n=172, 1394) |
|
| Solid Tumor: Month 18 (n=146, 1350) |
|
| Solid Tumor: Month 24 (n=141, 1245) |
|
| Solid Tumor: Month 30 (n=127, 1097) |
|
| Solid Tumor: Month 36 (n=128, 1027) |
|
| Solid Tumor: Month 48 (n=114, 815) |
|
| Solid Tumor: Month 60 (n=108, 516) |
|
| Chi-squared |
| 0.0774 |
| 2-Sided |
| No |
| Superiority or Other |
| Lymphoproliferative Tumors, Month 18: p-value was calculated using chi-square test. | Chi-squared | 0.0024 | 2-Sided | No | Superiority or Other |
| Lymphoproliferative Tumors, Month 30: p-value was calculated using chi-square test. | Chi-squared | 0.5552 | 2-Sided | No | Superiority or Other |
| Lymphoproliferative Tumors, Month 36: p-value was calculated using chi-square test. | Chi-squared | 0.0793 | 2-Sided | No | Superiority or Other |
| Lymphoproliferative Tumors, Month 48: p-value was calculated using chi-square test. | Chi-squared | 0.0075 | 2-Sided | No | Superiority or Other |
| Hodgkins Lymphoma, Month 6: p-value was calculated using chi-square test. | Chi-squared | 0.0895 | 2-Sided | No | Superiority or Other |
| Hodgkins Lymphoma, Month 18: p-value was calculated using chi-square test. | Chi-squared | 0.0024 | 2-Sided | No | Superiority or Other |
| Hodgkins Lymphoma, Month 30: p-value was calculated using chi-square test. | Chi-squared | 0.6301 | 2-Sided | No | Superiority or Other |
| Hodgkins Lymphoma, Month 36: p-value was calculated using chi-square test. | Chi-squared | 0.0793 | 2-Sided | No | Superiority or Other |
| Hodgkins Lymphoma, Month 48: p-value was calculated using chi-square test. | Chi-squared | 0.0075 | 2-Sided | No | Superiority or Other |
| Myeloma, Month 12: p-value was calculated using chi-square test. | Chi-squared | 0.7253 | 2-Sided | No | Superiority or Other |
| Myeloma, Month 30: p-value was calculated using chi-square test. | Chi-squared | 0.7336 | 2-Sided | No | Superiority or Other |
| Leukaemia, Month 12: p-value was calculated using chi-square test. | Chi-squared | 0.0044 | 2-Sided | No | Superiority or Other |
| Non-Melanoma Skin Cancer, Month 6: p-value was calculated using chi-square test. | Chi-squared | 0.4175 | 2-Sided | No | Superiority or Other |
| Non-Melanoma Skin Cancer, Month 12: p-value was calculated using chi-square test. | Chi-squared | 0.3886 | 2-Sided | No | Superiority or Other |
| Non-Melanoma Skin Cancer, Month 18: p-value was calculated using chi-square test. | Chi-squared | 0.5102 | 2-Sided | No | Superiority or Other |
| Non-Melanoma Skin Cancer, Month 24: p-value was calculated using chi-square test. | Chi-squared | 0.9855 | 2-Sided | No | Superiority or Other |
| Non-Melanoma Skin Cancer, Month 30: p-value was calculated using chi-square test. | Chi-squared | 0.4955 | 2-Sided | No | Superiority or Other |
| Non-Melanoma Skin Cancer, Month 36: p-value was calculated using chi-square test. | Chi-squared | 0.5404 | 2-Sided | No | Superiority or Other |
| Non-Melanoma Skin Cancer, Month 48: p-value was calculated using chi-square test. | Chi-squared | 0.3581 | 2-Sided | No | Superiority or Other |
| Solid Tumor, Month 6: p-value was calculated using chi-square test. | Chi-squared | 0.4932 | 2-Sided | No | Superiority or Other |
| Solid Tumor, Month 12: p-value was calculated using chi-square test. | Chi-squared | 0.4818 | 2-Sided | No | Superiority or Other |
| Solid Tumor, Month 18: p-value was calculated using chi-square test. | Chi-squared | 0.3224 | 2-Sided | No | Superiority or Other |
| Solid Tumor, Month 24: p-value was calculated using chi-square test. | Chi-squared | 0.5003 | 2-Sided | No | Superiority or Other |
| Solid Tumor, Month 30: p-value was calculated using chi-square test. | Chi-squared | 0.1134 | 2-Sided | No | Superiority or Other |
| Solid Tumor, Month 36: p-value was calculated using chi-square test. | Chi-squared | 0.3488 | 2-Sided | No | Superiority or Other |
| Solid Tumor, Month 48: p-value was calculated using chi-square test. | Chi-squared | 0.1870 | 2-Sided | No | Superiority or Other |
| Solid Tumor, Month 60: p-value was calculated using chi-square test. | Chi-squared | 0.4270 | 2-Sided | No | Superiority or Other |
| Death Due to AE: Month 18 (n=12, 111) |
|
| Death Due to AE: Month 24 (n=10, 102) |
|
| Death Due to AE: Month 30 (n=12, 80) |
|
| Death Due to AE: Month 36 (n=6, 91) |
|
| Death Due to AE: Month 48 (n=3, 63) |
|
| Death Due to AE: Month 60 (n=7, 44) |
|
| Hospitalization Due to AE: Month 6 (n= 18, 85) |
|
| Hospitalization Due to AE: Month 12 (n= 8, 81) |
|
| Hospitalization Due to AE: Month 18 (n= 11, 77) |
|
| Hospitalization Due to AE: Month 24 (n= 5, 70) |
|
| Hospitalization Due to AE: Month 30 (n= 8, 64) |
|
| Hospitalization Due to AE: Month 36 (n= 4, 69) |
|
| Hospitalization Due to AE: Month 48 (n= 1, 38) |
|
| Hospitalization Due to AE: Month 60 (n= 4, 24) |
|
| Chi-squared |
| 0.2595 |
| 2-Sided |
| No |
| Superiority or Other |
| Death Due to AE, Month 18: p-value was calculated using chi-square test. | Chi-squared | 0.5642 | 2-Sided | No | Superiority or Other |
| Death Due to AE, Month 24: p-value was calculated using chi-square test. | Chi-squared | 0.0034 | 2-Sided | No | Superiority or Other |
| Death Due to AE, Month 36: p-value was calculated using chi-square test. | Chi-squared | 0.7137 | 2-Sided | No | Superiority or Other |
| Death Due to AE, Month 60: p-value was calculated using chi-square test. | Chi-squared | 0.9630 | 2-Sided | No | Superiority or Other |
| Hospitalization Due to AE, Month 6: p-value was calculated using chi-square test. | Chi-squared | 0.7353 | 2-Sided | No | Superiority or Other |
| Hospitalization Due to AE, Month 12: p-value was calculated using chi-square test. | Chi-squared | 0.3829 | 2-Sided | No | Superiority or Other |
| Hospitalization Due to AE, Month 18: p-value was calculated using chi-square test. | Chi-squared | 0.4532 | 2-Sided | No | Superiority or Other |
| Hospitalization Due to AE, Month 24: p-value was calculated using chi-square test. | Chi-squared | 0.4238 | 2-Sided | No | Superiority or Other |
| Hospitalization Due to AE, Month 30: p-value was calculated using chi-square test. | Chi-squared | 0.1218 | 2-Sided | No | Superiority or Other |
| Hospitalization Due to AE, Month 36: p-value was calculated using chi-square test. | Chi-squared | 0.4124 | 2-Sided | No | Superiority or Other |
| Hospitalization Due to AE, Month 48: p-value was calculated using chi-square test. | Chi-squared | 0.6356 | 2-Sided | No | Superiority or Other |
| Hospitalization Due to AE, Month 60: p-value was calculated using chi-square test. | Chi-squared | 0.5491 | 2-Sided | No | Superiority or Other |
| Vitality Score (n= 104, 711) |
|
MCS: p-value was calculated using multivariate linear regression with baseline MCS and other baseline variables (socio-demographics, disease characteristics, and initial treatment profile) as covariates.
| Regression, Linear |
| 0.4908 |
| 2-Sided |
| No |
| Superiority or Other |
| Vitality Score: p-value was calculated using multivariate linear regression with baseline vitality score and other baseline variables (socio-demographics, disease characteristics, and initial treatment profile) as covariates. | Regression, Linear | 0.8379 | 2-Sided | No | Superiority or Other |