Rheumatoid ArthritisNCT01557322
Characterize Patients With Moderately Active Rheumatoid Arthritis (RA)
An observational study of Rheumatoid Arthritis, run by Pfizer.
Trial summary
1. To assess the baseline (i.e. RA therapy initiation) characteristics in a real-world setting across two moderate RA cohorts: a Test Group of patients newly exposed to etanercept (Enbrel) therapy and a Control Group of patients with similar disease characteristics newly exposed to other, non-biologic therapies. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- etanercept and methotrexate (MTX)
- How many people
- 1,754 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Sep 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- The Test Group will be patients with rheumatoid arthritis, newly starting therapy with etanercept (Enbrel). Inclusion criteria for the exposed cohort subjects are:
- Patients aged 18 years and over at the time of diagnosis;
- Patients from the BSRBR with moderate RA as defined by a DAS28 (>3.2 and ≤5.1);
- Patients who have given informed consent for long term follow-up and access to all medical records;
- Patients initiating (i.e. at leats one treatment) treatment with etanercept (Enbrel) for RA.
- The Control Group:
Show all 9Show fewer
- Patients aged 18 years and over a the time of diagnosis;
- Patients from the BSRBR with moderate RA as defined by a DAS28 (>3.2 and ≤5.1);
- Patients who have given informed consent for long term follow-up and access to all medical records; Patients are receiving at least one traditional DMARD and have never been prescribed a biologic agent;
Who cannot join
- Per BSRBR registry since data is retropsectively being analyzed
About this study
Official title: Evaluation of the Clinical Characteristics, Real-world Treatment Pathways, and Outcomes of Patients With Moderate Rheumatoid Arthritis
- To assess the baseline (i.e. RA therapy initiation) characteristics in a real-world setting across two moderate RA cohorts: a Test Group of patients newly exposed to etanercept (Enbrel) therapy and a Control Group of patients with similar disease characteristics newly exposed to other, non-biologic therapies.
- To assess the change over time (from baseline to the most recent follow-up) in the characteristics described at baseline in 2 British Society for Rheumatology Biologics Register (BSRBR) cohorts (i.e. moderate RA patients treated with Disease modifying anti-rheumatic drugs (DMARDs) alone versus moderate RA patients treated with Enbrel).
Read the detailed description
Retrospective database analysis
- Conditions
- Rheumatoid Arthritis
- Being tested
- etanercept, methotrexate (MTX)
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etanerceptBiological
Also called Enrel
This is a Non-interventional study. The data is being analyzed retrospectively. The data consists of 2 cohorts; biologic and non-biologic
methotrexate (MTX)Drug
Also called non-biologic DMARD
This is a Non-interventional study. The data is being analyzed retrospectively. The data consists of 2 cohorts; biologic and non-biologic
| Study group | Role | What they receive |
|---|---|---|
| Biologic | Not described Receives: Biological: etanercept | |
| non-biologic DMARD | Not described Receives: Drug: methotrexate (MTX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: Baseline
Number of Participants With Chest X-Ray Prior to New Therapy
Measured: 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.
Measured: Baseline
Body Mass Index (BMI)
BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Month 60
Duration of Disease (Rheumatoid Arthritis)
Measured: Baseline
Time Since First Rheumatologist Visit
Measured: Baseline
Time Since Recalled Symptom Onset
RA symptoms include joint pain, stiffness, and swelling.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline, Month 60
Time to Disease Worsening
Disease worsening (severe RA diagnosis) was defined as DAS28 score >5.1.
Measured: Baseline up to Month 60
Time to Therapeutic Goal
Therapeutic goal achievement was based on physician's discretion.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2012 (estimated)
- Study startOct 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,754 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01557322
- Sponsor's protocol ID
- B1801345
- Status last verified
- Aug 2013
- First submitted
- 8 Feb 2012
- Last updated
- 31 Oct 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Characteristics, Real-world Treatment Pathways, and Outcomes of Patients With Moderate Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01557322
- Acronym / sponsor ID
- B1801345
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,754 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 19 Mar 2012 (estimated)
- Results
- Posted 31 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To assess the baseline (i.e. RA therapy initiation) characteristics in a real-world setting across two moderate RA cohorts: a Test Group of patients newly exposed to etanercept (Enbrel) therapy and a Control Group of patients with similar disease characteristics newly exposed to other, non-biologic therapies.
- To assess the change over time (from baseline to the most recent follow-up) in the characteristics described at baseline in 2 British Society for Rheumatology Biologics Register (BSRBR) cohorts (i.e. moderate RA patients treated with Disease modifying anti-rheumatic drugs (DMARDs) alone versus moderate RA patients treated with Enbrel).
Detailed description
Retrospective database analysis
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biologic | – | Biological: etanercept |
| non-biologic DMARD | – | Drug: methotrexate (MTX) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (9 listed)
- The Test Group will be patients with rheumatoid arthritis, newly starting therapy with etanercept (Enbrel). Inclusion criteria for the exposed cohort subjects are:
- Patients aged 18 years and over at the time of diagnosis;
- Patients from the BSRBR with moderate RA as defined by a DAS28 (>3.2 and ≤5.1);
- Patients who have given informed consent for long term follow-up and access to all medical records;
- Patients initiating (i.e. at leats one treatment) treatment with etanercept (Enbrel) for RA.
Key exclusion criteria (1 listed)
- Per BSRBR registry since data is retropsectively being analyzed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| etanerceptAlso: EnrelThis is a Non-interventional study. The data is being analyzed retrospectively. The data consists of 2 cohorts; biologic and non-biologic | Biological | Biologic |
| methotrexate (MTX)Also: non-biologic DMARDThis is a Non-interventional study. The data is being analyzed retrospectively. The data consists of 2 cohorts; biologic and non-biologic | Drug | non-biologic DMARD |
Primary outcome
Number of Participants With American College of Rheumatology (ACR) Criteria
Time frame: Baseline
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.
Number of Participants With Systemic Features
Time frame: Baseline
Systemic features included sicca syndrome, serosal involvement (pleurisy/pericarditis), eye involvement, systemic vasculitis, nailfold vasculitis, pulmonary fibrosis, and others (other than those specified).
Number of Participants With Prior Joint Replacement or Surgery
Time frame: 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.
Number of Participants With Chest X-Ray Prior to New Therapy
Time frame: Baseline
Number of Participants With Comorbidities
Time frame: Baseline
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.
Body Mass Index (BMI)
Time frame: Baseline
BMI was calculated by weight divided by height squared and measured as kilogram per square meter (kg/m^2).
Blood Pressure (BP)
Time frame: Baseline
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).
Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) at Month 60
Time frame: Baseline, 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.
Change From Baseline in Tender Joints Count (TJC) at Month 60
Time frame: Baseline, 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.
Change From Baseline in Swollen Joints Count (SJC) at Month 60
Time frame: Baseline, 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.
Change From Baseline in C-Reactive Protein (CRP) Level at Month 60
Time frame: Baseline, 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.
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 60
Time frame: Baseline, 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.
Change From Baseline in Patient's Global Assessment (PtGA) of Disease Activity at Month 60
Time frame: Baseline, 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.
Duration of Disease (Rheumatoid Arthritis)
Time frame: Baseline
Time Since First Rheumatologist Visit
Time frame: Baseline
Time Since Recalled Symptom Onset
Time frame: Baseline
RA symptoms include joint pain, stiffness, and swelling.
Number of Participants With Previous and Current Disease Modifying Anti-Rheumatic Drugs (DMARDs)
Time frame: Baseline
Number of participants who previously received DMARDs or were currently on DMARDs at baseline is reported.
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Month 60
Time frame: Baseline, 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.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Month 60
Time frame: Baseline, 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).
Change From Baseline in Euro Quality of Life - 5 Dimensions (EQ-5D) at Month 60
Time frame: Baseline, 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.
Time to Disease Worsening
Time frame: Baseline up to Month 60
Disease worsening (severe RA diagnosis) was defined as DAS28 score >5.1.
Time to Therapeutic Goal
Time frame: Baseline up to Month 60
Therapeutic goal achievement was based on physician's discretion.
Change From Baseline in Pain Visual Analog Scale (VAS) Score at Month 60
Time frame: Baseline, 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.
Number of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 60
Time frame: 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).
Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 60
Time frame: 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.
Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 60
Time frame: 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.
Number of Rheumatoid Arthritis (RA) Related Visits
Time frame: Baseline
Number of RA-related visits to doctor/healthcare professional in previous 3 months was to be reported.
Direct and Indirect Cost of Rheumatoid Arthritis (RA) Treatment
Time frame: Baseline
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 and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With American College of Rheumatology (ACR) Criteria (time frame: Baseline). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2013.