Rheumatoid Arthritis
Conditions
Keywords
Observational cohort, prospectives, multicentre, the Italian study RA patient CLARA and PRO-CLARA
Brief summary
This is an observational study of composite indices, including the CLARA (CLinical ARthritis Activity) index, in rheumatoid arthritis (RA) patients in routine clinical practice in Italy in order to evaluate clinical remission and low disease activity. Data will be collected only from patients providing informed consent. In this study we aimed to assess the psychometric properties of a new composite instrument termed CLinical ARthritis Activity (PRO-CLARA) that uses only three PRO measures from among the 7 ACR Core Data Set. We hypothesized that this index would facilitate rapid and easy RA activity assessment in daily routine.
Detailed description
All patients who respond to inclusion/exclusion criteria at baseline will be considered valuable for the analysis.
Interventions
OTHERAs per routinary clinical care
As per routine clinical care
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eighteen years of age or older with diagnosis of RA based on the 1987 American College of Rheumatology (ACR) criteria and in accordance with local guidelines. * Patients eligible to anti-TNF therapy * Patients naïve to anti-TNFa drugs * Patients with radiography (hands and feet) executed by 6 months before the baseline or at baseline according to modified Sharp Van der Hejde method \[Sharp JT et al. 1985; Sharp JT. Et al. 1989; Van der Heijde DM et al. 1989\] Patients capable of understanding and completing the questionnaire Patients capable of understanding and signing an informed consent form
Exclusion criteria
* Patients with tumors * Patients already included in clinical trials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Remission as Per Modified American College of Rheumatology (Modified ACR) Criteria at Month 6 | Month 6 | Modified ACR: participant considered in RA remission if at any time point 1) participant satisfied all of the following criteria: tender joint count(TJC) less than or equal to(\<=)1;swollen joint count(SJC)\<=1 (TJC, SJC based on 28-joints);C-reactive protein(CRP)\<=1 milligram/deciliter(mg/dL); patient global assessment (PtGA) \<=1 (assessed on 0-10 centimeter\[cm\] visual analog scale\[VAS\]) or 2) participant had Simplified Disease Activity Index score of \<=3.3 (SDAI, numerical sum of 5 outcome parameters: TJC, SJC, PtGA, physician global assessment \[PGA, assessed on 0-10 cm VAS\], and CRP \[mg/dL\]). |
| Percentage of Participants With Remission as Per Modified American College of Rheumatology (Modified ACR) Criteria at Month 12 | Month 12 | Modified ACR: participant was considered in RA remission if at any time point 1) participant satisfied all of the following criteria: TJC \<=1; SJC \<=1 (TJC, SJC based on 28-joints); CRP \<=1 mg/dL; PtGA\<=1 (assessed on 0-10 centimeter\[cm\] visual analog scale\[VAS\]) or 2) participant had SDAI score of \<=3.3 (SDAI: the numerical sum of 5 outcome parameters: TJC, SJC, PtGA, PGA \[assessed on 0-10 cm VAS\], and CRP \[mg/dL\]). |
| Minimal Disease Activity: Outcome Measures in Rheumatology Arthritis Clinical Trials (OMERACT) at Month 6 | Month 6 | OMERACT minimal disease activity: participant considered with minimal disease activity if he/she met 5 of 7 criteria: Pain \<=2 (assessed on a 0-10 cm VAS, 0 cm=no pain and 10 cm=worst possible pain); SJC \<=1; TJC \<=1 (SJC, TJC based on 28-joints); Health Assessment Questionnaire (HAQ) \<=0.5 (assessment of ability to perform task on 0-3 point scale, 0=least difficulty and 3=extreme difficulty); PGA \<=1.5; PtGA \<=2 (PGA, PtGA: assessed on 0-10 cm VAS, higher score = greater affection due to disease activity); erythrocyte sedimentation rate (ESR) \<=20 millimeter per hour (mm/hr). |
| Minimal Disease Activity: Outcome Measures in Rheumatology Arthritis Clinical Trials (OMERACT) at Month 12 | Month 12 | OMERACT minimal disease activity: participant considered with minimal disease activity if he/she met 5 of 7 criteria: Pain \<=2 (assessed on a 0-10 cm VAS, 0 cm=no pain and 10 cm=worst possible pain); SJC \<=1; TJC \<=1 (SJC, TJC based on 28-joints); HAQ \<=0.5 (assessment of ability to perform task on 0-3 point scale, 0=least difficulty and 3=extreme difficulty); PGA \<=1.5; PtGA \<=2 (PGA, PtGA: assessed on 0-10 cm VAS, higher score = greater affection due to disease activity); ESR \<=20 mm/hr. |
| Minimal Disease Activity: Italian Group for the Study of Early Arthritis (GISEA) at Month 6 | Month 6 | GISEA minimal disease activity criteria: a participant was considered with minimal disease activity if he/she met the following criteria: SJC \<=2 (based on 28-joints); HAQ \<=0.5 (assessment of ability to perform task on 0-3 point scale, 0=least difficulty and 3=extreme difficulty); and ESR \<=20 mm/hr. |
| Minimal Disease Activity: Italian Group for the Study of Early Arthritis (GISEA) at Month 12 | Month 12 | GISEA minimal disease activity criteria: a participant was considered with minimal disease activity if he/she met the following criteria: SJC \<=2 (based on 28-joints); HAQ \<=0.5 (assessment of ability to perform task on 0-3 point scale, 0=least difficulty and 3=extreme difficulty); and ESR \<=20 mm/hr. |
| Number of Swollen Joints (SJC) and Tender Joints (TJC) at Month 6 | Month 6 | 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. 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. |
| Number of Swollen Joints (SJC) and Tender Joints (TJC) at Month 12 | Month 12 | 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. 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. |
| Disease Activity Score Based on 28-joints Count (DAS28) at Month 6 | Month 6 | DAS28 calculated from SJC and TJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10 cm VAS; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28 \<= 3.2 implied low disease activity and \> 3.2 to 5.1 implied moderate to high disease activity, and DAS28 \< 2.6 = remission. |
| Disease Activity Score Based on 28-joints Count (DAS28) at Month 12 | Month 12 | DAS28 calculated from SJC and TJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10 cm VAS; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28 \<= 3.2 implied low disease activity and \> 3.2 to 5.1 implied moderate to high disease activity, and DAS28 \< 2.6 = remission. |
| Simplified Disease Activity Index (SDAI) at Month 6 | Month 6 | The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PGA (assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity), and CRP (mg/dL). SDAI total score= 0-86. SDAI \<=3.3 indicates disease remission, \>3.4 to 11 = low disease activity, \>11 to 26 = moderate disease activity, and \>26 = high disease activity. |
| Simplified Disease Activity Index (SDAI) at Month 12 | Month 12 | The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PGA (assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity), and CRP (mg/dL). SDAI total score= 0-86. SDAI \<=3.3 indicates disease remission, \>3.4 to 11 = low disease activity, \>11 to 26 = moderate disease activity, and \>26 = high disease activity. |
| Rheumatoid Arthritis Disease Activity Index (RADAI) at Month 6 | Month 6 | RADAI:self-assessed measure of disease activity in RA. Consists of 5 items: global disease activity(GDA) in past 6 months; current disease activity(CDA) as measured by SJC and TJC; current arthritis pain; current duration of morning stiffness; current TJC. GDA,CDA and pain were scored on an 11-point numerical rating scale,0=no disease activity/pain to 10=extreme disease activity/pain. Current morning stiffness and TJC were transformed to a 0-10 point scale,higher scores=more disease activity. RADAI total score=sum of individual items divided by 5;range 0-10, higher score=more disease activity. |
| Rheumatoid Arthritis Disease Activity Index (RADAI) at Month 12 | Month 12 | RADAI:self-assessed measure of disease activity in RA. Consists of 5 items: GDA in past 6 months; CDA as measured by SJC and TJC; current arthritis pain; current duration of morning stiffness; current TJC. GDA,CDA and pain were scored on an 11-point numerical rating scale,0=no disease activity/pain to 10=extreme disease activity/pain. Current morning stiffness and TJC were transformed to a 0-10 point scale,higher scores=more disease activity. RADAI total score=sum of individual items divided by 5;range 0-10, higher score=more disease activity. |
| Clinical Disease Activity Index (CDAI) at Month 6 | Month 6 | The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PGA (assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity). CDAI total score = 0-76. CDAI \<= 2.8 indicates disease remission, \>2.8 to 10 = low disease activity, \>10 to 22 = moderate disease activity, and \>22 = high disease activity. |
| Clinical Disease Activity Index (CDAI) at Month 12 | Month 12 | The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PGA (assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity). CDAI total score = 0-76. CDAI \<= 2.8 indicates disease remission, \>2.8 to 10 = low disease activity, \>10 to 22 = moderate disease activity, and \>22 = high disease activity. |
| Patient Reported Outcomes - Clinical Arthritis Activity (PRO-CLARA ) at Month 6 | Month 6 | PRO-CLARA:self-administered index of RA activity. Consists of 3-items: participant's physical function (12 questions each scored on a 0 \[without any difficulty\] to 4 \[unable to do\] point scale); TJC(based on 16-joints, tenderness assessed on 0 \[none\] to 3 \[severe\] point scale); PtGA (participant rated disease activity on 0-10 cm VAS, 0=very well, 10 cm=very poorly). Participant's physical function and TJC were transformed on a 0-10 point scale, higher scores=more disease activity. PRO-CLARA total score=sum of scores of all 3 items divided by 3, range= 0-10, higher scores=more disease activity. |
| Patient Reported Outcomes - Clinical Arthritis Activity (PRO-CLARA ) at Month 12 | Month 12 | PRO-CLARA:self-administered index of RA activity. Consists of 3-items: participant's physical function (12 questions each scored on a 0 \[without any difficulty\] to 4 \[unable to do\] point scale); TJC(based on 16-joints, tenderness assessed on 0 \[none\] to 3 \[severe\] point scale); PtGA (participant rated disease activity on 0-10 cm VAS, 0=very well, 10 cm=very poorly). Participant's physical function and TJC were transformed on a 0-10 point scale, higher scores=more disease activity. PRO-CLARA total score=sum of scores of all 3 items divided by 3, range= 0-10, higher scores=more disease activity. |
| Clinical Arthritis Activity (CLARA) Index at Month 6 | Month 6 | CLARA: index of RA activity. Consists of 3-items: participant's physical function (12 questions each scored on a 0 \[without any difficulty\] to 4 \[unable to do\] point scale); TJC (based on 16-joints, tenderness assessed on 0 \[none\] to 3 \[severe\] point scale); SJC (based on 28-joints). Each item was transformed on a 0-10 point scale, higher scores=more disease activity. CLARA total score=sum of scores of all 3 items divided by 3, range= 0-10, higher scores=more disease activity. |
| Clinical Arthritis Activity (CLARA) Index at Month 12 | Month 12 | CLARA: index of RA activity. Consists of 3-items: participant's physical function (12 questions each scored on a 0 \[without any difficulty\] to 4 \[unable to do\] point scale); TJC (based on 16-joints, tenderness assessed on 0 \[none\] to 3 \[severe\] point scale); SJC (based on 28-joints). Each item was transformed on a 0-10 point scale, higher scores=more disease activity. CLARA total score=sum of scores of all 3 items divided by 3, range= 0-10, higher scores=more disease activity. |
| Patient Global Assessment (PtGA) of Disease Activity at Month 6 | Month 6 | Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 10 cm VAS, where 0 cm = very well and 10 cm = very poorly. |
| Patient Global Assessment (PtGA) of Disease Activity at Month 12 | Month 12 | Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 10 cm VAS, where 0 cm = very well and 10 cm = very poorly. |
| Physician Global Assessment (PGA) of Disease Activity at Month 6 | Month 6 | Physician Global Assessment of Arthritis was measured on a 0 to 10 cm VAS, where 0 cm = very good and 10 cm = very bad. |
| Physician Global Assessment (PGA) of Disease Activity at Month 12 | Month 12 | Physician Global Assessment of Arthritis was measured on a 0 to 10 cm VAS, where 0 cm = very good and 10 cm = very bad. |
| Visual Analog Fatigue Scale (VAFS) at Month 6 | Month 6 | Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. |
| Visual Analog Fatigue Scale (VAFS) at Month 12 | Month 12 | Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue. |
| C-reactive Protein (CRP) at Month 6 | Month 6 | The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is \<1 mg/dL. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. |
| C-reactive Protein (CRP) at Month 12 | Month 12 | The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is \<1 mg/dL. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. |
| Erythrocyte Sedimentation Rate (ESR) at Month 6 | Month 6 | 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 mm/hr. A higher rate is consistent with inflammation. |
| Erythrocyte Sedimentation Rate (ESR) at Month 12 | Month 12 | 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 mm/hr. A higher rate is consistent with inflammation. |
| Number of Participants With Rheumatoid Factor (RF) at Month 6 | Month 6 | RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 units per milliliter (U/mL) is considered positive. |
| Number of Participants With Rheumatoid Factor (RF) at Month 12 | Month 12 | RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive. |
| Patient's General Health Assessment at Month 6 | Month 6 | Participants answered: How would you describe your general health today? Participants assessed their general health using a 0 - 10 cm VAS, where 0 cm = very well and 10 cm = very poor. |
| Patient's General Health Assessment at Month 12 | Month 12 | Participants answered: How would you describe your general health today? Participants assessed their general health using a 0 - 10 cm VAS, where 0 cm = very well and 10 cm = very poor. |
| Patient Assessment of Arthritis Pain at Month 6 | Month 6 | Participants rated the severity of arthritis pain on a 0 to 10 cm VAS, where 0 cm = no pain and 10 cm = most severe pain. |
| Patient Assessment of Arthritis Pain at Month 12 | Month 12 | Participants rated the severity of arthritis pain on a 0 to 10 cm VAS, where 0 cm = no pain and 10 cm = most severe pain. |
| Duration of Morning Stiffness at Month 6 | Month 6 | Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. |
| Duration of Morning Stiffness at Month 12 | Month 12 | Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. |
| Health Assessment Questionnaire (HAQ) at Month 6 | Month 6 | HAQ: 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 0-3 where 0 = least difficulty and 3 = extreme difficulty. |
| Health Assessment Questionnaire (HAQ) at Month 12 | Month 12 | HAQ: 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 0-3 where 0 = least difficulty and 3 = extreme difficulty. |
| Recent-Onset Arthritis Disability (ROAD) at Month 6 | Month 6 | ROAD questionnaire: valid and responsive tool for measuring functional ability in RA participants. Consists of 12-items related to fine movements of upper extremity, locomotor activities of lower extremity, and activities that involve both upper and lower extremities. For each item participant rated the level of difficulty over the past week on a 5-point scale ranging from 0 (without any difficulty) to 4 (unable to do). Total ROAD score were transformed to a 0 to 10 point scale, where 0 = best status and 10 = poorest status. |
| Recent-Onset Arthritis Disability (ROAD) at Month 12 | Month 12 | ROAD questionnaire: valid and responsive tool for measuring functional ability in RA participants. Consists of 12-items related to fine movements of upper extremity, locomotor activities of lower extremity, and activities that involve both upper and lower extremities. For each item participant rated the level of difficulty over the past week on a 5-point scale ranging from 0 (without any difficulty) to 4 (unable to do). Total ROAD score were transformed to a 0 to 10 point scale, where 0 = best status and 10 = poorest status. |
| Radiological Assessment of Hands and Feet Based on Sharp-van Der Hejde (SvH) Scoring Method at Month 6 | Month 6 | SvH method included 16 areas for erosions and 15 areas for joint space narrowing (JSN) and subluxation/luxation in each hand, 6 areas for erosions and 6 areas for JSN and subluxation/luxation in each foot. Erosion per joint scored on 0-5 point scale; 0=normal joint to 5=complete collapse. Total erosion score for hands:0-160, for feet:0-120. JSN and subluxation/luxation scored on 0-4 point scale; 0=normal joint to 4= a bony ankylosis/a complete luxation of joint. Total JSN and subluxation/luxation score for hands:0-120, for feet:0-48. Total SvH score = 0-448; higher score=more erosion and JSN. |
| Radiological Assessment of Hands and Feet Based on Sharp-Van Der Hejde (SvH) Scoring Method at Month 12 | Month 12 | SvH method included 16 areas for erosions and 15 areas for JSN and subluxation/luxation in each hand, 6 areas for erosions and 6 areas for JSN and subluxation/luxation in each foot. Erosion per joint scored on 0-5 point scale; 0=normal joint to 5=complete collapse. Total erosion score for hands:0-160, for feet:0-120. JSN and subluxation/luxation scored on 0-4 point scale; 0=normal joint to 4= a bony ankylosis/a complete luxation of joint. Total JSN and subluxation/luxation score for hands:0-120, for feet:0-48. Total SvH score = 0-448; higher score=more erosion and JSN. |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months. | 220 |
| Total | 220 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Other | 73 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age Continuous | 55.65 Years STANDARD_DEVIATION 12.18 |
| Sex: Female, Male Female | 182 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 293 |
| serious Total, serious adverse events | 4 / 293 |
Outcome results
Primary
Clinical Arthritis Activity (CLARA) Index at Month 12
CLARA: index of RA activity. Consists of 3-items: participant's physical function (12 questions each scored on a 0 \[without any difficulty\] to 4 \[unable to do\] point scale); TJC (based on 16-joints, tenderness assessed on 0 \[none\] to 3 \[severe\] point scale); SJC (based on 28-joints). Each item was transformed on a 0-10 point scale, higher scores=more disease activity. CLARA total score=sum of scores of all 3 items divided by 3, range= 0-10, higher scores=more disease activity.
Time frame: Month 12
Population: Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Clinical Arthritis Activity (CLARA) Index at Month 12 | 1.39 Units on a scale | Standard Deviation 1.33 |
Primary
Clinical Arthritis Activity (CLARA) Index at Month 6
CLARA: index of RA activity. Consists of 3-items: participant's physical function (12 questions each scored on a 0 \[without any difficulty\] to 4 \[unable to do\] point scale); TJC (based on 16-joints, tenderness assessed on 0 \[none\] to 3 \[severe\] point scale); SJC (based on 28-joints). Each item was transformed on a 0-10 point scale, higher scores=more disease activity. CLARA total score=sum of scores of all 3 items divided by 3, range= 0-10, higher scores=more disease activity.
Time frame: Month 6
Population: Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Clinical Arthritis Activity (CLARA) Index at Month 6 | 1.79 Units on a scale | Standard Deviation 1.37 |
Primary
Clinical Disease Activity Index (CDAI) at Month 12
The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PGA (assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity). CDAI total score = 0-76. CDAI \<= 2.8 indicates disease remission, \>2.8 to 10 = low disease activity, \>10 to 22 = moderate disease activity, and \>22 = high disease activity.
Time frame: Month 12
Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.
Primary
Clinical Disease Activity Index (CDAI) at Month 6
The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PGA (assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity). CDAI total score = 0-76. CDAI \<= 2.8 indicates disease remission, \>2.8 to 10 = low disease activity, \>10 to 22 = moderate disease activity, and \>22 = high disease activity.
Time frame: Month 6
Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.
Primary
C-reactive Protein (CRP) at Month 12
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is \<1 mg/dL. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time frame: Month 12
Population: Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | C-reactive Protein (CRP) at Month 12 | 1.63 mg/dL | Standard Deviation 2.25 |
Primary
C-reactive Protein (CRP) at Month 6
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is \<1 mg/dL. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time frame: Month 6
Population: Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | C-reactive Protein (CRP) at Month 6 | 2.16 mg/dL | Standard Deviation 4.07 |
Primary
Disease Activity Score Based on 28-joints Count (DAS28) at Month 12
DAS28 calculated from SJC and TJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10 cm VAS; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28 \<= 3.2 implied low disease activity and \> 3.2 to 5.1 implied moderate to high disease activity, and DAS28 \< 2.6 = remission.
Time frame: Month 12
Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.
Primary
Disease Activity Score Based on 28-joints Count (DAS28) at Month 6
DAS28 calculated from SJC and TJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10 cm VAS; higher scores indicated greater affectation due to disease activity). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28 \<= 3.2 implied low disease activity and \> 3.2 to 5.1 implied moderate to high disease activity, and DAS28 \< 2.6 = remission.
Time frame: Month 6
Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.
Primary
Duration of Morning Stiffness at Month 12
Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time frame: Month 12
Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.
Primary
Duration of Morning Stiffness at Month 6
Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time frame: Month 6
Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.
Primary
Erythrocyte Sedimentation Rate (ESR) at Month 12
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 mm/hr. A higher rate is consistent with inflammation.
Time frame: Month 12
Population: Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Erythrocyte Sedimentation Rate (ESR) at Month 12 | 21.92 mm/hour | Standard Deviation 15.65 |
Primary
Erythrocyte Sedimentation Rate (ESR) at Month 6
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 mm/hr. A higher rate is consistent with inflammation.
Time frame: Month 6
Population: Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Erythrocyte Sedimentation Rate (ESR) at Month 6 | 26.02 mm/hr | Standard Deviation 19.19 |
Primary
Health Assessment Questionnaire (HAQ) at Month 12
HAQ: 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 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Time frame: Month 12
Population: Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Health Assessment Questionnaire (HAQ) at Month 12 | 0.68 Units on a scale | Standard Deviation 0.66 |
Primary
Health Assessment Questionnaire (HAQ) at Month 6
HAQ: 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 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Time frame: Month 6
Population: Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Health Assessment Questionnaire (HAQ) at Month 6 | 0.83 Units on a scale | Standard Deviation 0.65 |
Primary
Minimal Disease Activity: Italian Group for the Study of Early Arthritis (GISEA) at Month 12
GISEA minimal disease activity criteria: a participant was considered with minimal disease activity if he/she met the following criteria: SJC \<=2 (based on 28-joints); HAQ \<=0.5 (assessment of ability to perform task on 0-3 point scale, 0=least difficulty and 3=extreme difficulty); and ESR \<=20 mm/hr.
Time frame: Month 12
Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.
Primary
Minimal Disease Activity: Italian Group for the Study of Early Arthritis (GISEA) at Month 6
GISEA minimal disease activity criteria: a participant was considered with minimal disease activity if he/she met the following criteria: SJC \<=2 (based on 28-joints); HAQ \<=0.5 (assessment of ability to perform task on 0-3 point scale, 0=least difficulty and 3=extreme difficulty); and ESR \<=20 mm/hr.
Time frame: Month 6
Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.
Primary
Minimal Disease Activity: Outcome Measures in Rheumatology Arthritis Clinical Trials (OMERACT) at Month 12
OMERACT minimal disease activity: participant considered with minimal disease activity if he/she met 5 of 7 criteria: Pain \<=2 (assessed on a 0-10 cm VAS, 0 cm=no pain and 10 cm=worst possible pain); SJC \<=1; TJC \<=1 (SJC, TJC based on 28-joints); HAQ \<=0.5 (assessment of ability to perform task on 0-3 point scale, 0=least difficulty and 3=extreme difficulty); PGA \<=1.5; PtGA \<=2 (PGA, PtGA: assessed on 0-10 cm VAS, higher score = greater affection due to disease activity); ESR \<=20 mm/hr.
Time frame: Month 12
Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.
Primary
Minimal Disease Activity: Outcome Measures in Rheumatology Arthritis Clinical Trials (OMERACT) at Month 6
OMERACT minimal disease activity: participant considered with minimal disease activity if he/she met 5 of 7 criteria: Pain \<=2 (assessed on a 0-10 cm VAS, 0 cm=no pain and 10 cm=worst possible pain); SJC \<=1; TJC \<=1 (SJC, TJC based on 28-joints); Health Assessment Questionnaire (HAQ) \<=0.5 (assessment of ability to perform task on 0-3 point scale, 0=least difficulty and 3=extreme difficulty); PGA \<=1.5; PtGA \<=2 (PGA, PtGA: assessed on 0-10 cm VAS, higher score = greater affection due to disease activity); erythrocyte sedimentation rate (ESR) \<=20 millimeter per hour (mm/hr).
Time frame: Month 6
Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.
Primary
Number of Participants With Rheumatoid Factor (RF) at Month 12
RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.
Time frame: Month 12
Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.
Primary
Number of Participants With Rheumatoid Factor (RF) at Month 6
RF is the auto antibody directed against immunoglobulin G (IgG) and its concentration is observed in human serum or plasma. RF value higher than 20 units per milliliter (U/mL) is considered positive.
Time frame: Month 6
Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.
Primary
Number of Swollen Joints (SJC) and Tender Joints (TJC) at Month 12
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. 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.
Time frame: Month 12
Population: Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Number of Swollen Joints (SJC) and Tender Joints (TJC) at Month 12 | SJC | 1.28 Joints | Standard Deviation 2.72 |
| All Participants | Number of Swollen Joints (SJC) and Tender Joints (TJC) at Month 12 | TJC | 2.35 Joints | Standard Deviation 3.47 |
Primary
Number of Swollen Joints (SJC) and Tender Joints (TJC) at Month 6
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. 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.
Time frame: Month 6
Population: Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Number of Swollen Joints (SJC) and Tender Joints (TJC) at Month 6 | SJC | 2.80 Joints | Standard Deviation 3.84 |
| All Participants | Number of Swollen Joints (SJC) and Tender Joints (TJC) at Month 6 | TJC | 4.62 Joints | Standard Deviation 5.01 |
Primary
Patient Assessment of Arthritis Pain at Month 12
Participants rated the severity of arthritis pain on a 0 to 10 cm VAS, where 0 cm = no pain and 10 cm = most severe pain.
Time frame: Month 12
Population: Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Patient Assessment of Arthritis Pain at Month 12 | 3.29 cm | Standard Deviation 2.31 |
Primary
Patient Assessment of Arthritis Pain at Month 6
Participants rated the severity of arthritis pain on a 0 to 10 cm VAS, where 0 cm = no pain and 10 cm = most severe pain.
Time frame: Month 6
Population: Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Patient Assessment of Arthritis Pain at Month 6 | 3.58 cm | Standard Deviation 2.31 |
Primary
Patient Global Assessment (PtGA) of Disease Activity at Month 12
Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 10 cm VAS, where 0 cm = very well and 10 cm = very poorly.
Time frame: Month 12
Population: Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Patient Global Assessment (PtGA) of Disease Activity at Month 12 | 3.35 cm | Standard Deviation 2.21 |
Primary
Patient Global Assessment (PtGA) of Disease Activity at Month 6
Participants answered: Considering all the ways your arthritis affects you, how are you feeling today? Participants responded by using a 0 - 10 cm VAS, where 0 cm = very well and 10 cm = very poorly.
Time frame: Month 6
Population: Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Patient Global Assessment (PtGA) of Disease Activity at Month 6 | 3.71 cm | Standard Deviation 2.23 |
Primary
Patient Reported Outcomes - Clinical Arthritis Activity (PRO-CLARA ) at Month 12
PRO-CLARA:self-administered index of RA activity. Consists of 3-items: participant's physical function (12 questions each scored on a 0 \[without any difficulty\] to 4 \[unable to do\] point scale); TJC(based on 16-joints, tenderness assessed on 0 \[none\] to 3 \[severe\] point scale); PtGA (participant rated disease activity on 0-10 cm VAS, 0=very well, 10 cm=very poorly). Participant's physical function and TJC were transformed on a 0-10 point scale, higher scores=more disease activity. PRO-CLARA total score=sum of scores of all 3 items divided by 3, range= 0-10, higher scores=more disease activity.
Time frame: Month 12
Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.
Primary
Patient Reported Outcomes - Clinical Arthritis Activity (PRO-CLARA ) at Month 6
PRO-CLARA:self-administered index of RA activity. Consists of 3-items: participant's physical function (12 questions each scored on a 0 \[without any difficulty\] to 4 \[unable to do\] point scale); TJC(based on 16-joints, tenderness assessed on 0 \[none\] to 3 \[severe\] point scale); PtGA (participant rated disease activity on 0-10 cm VAS, 0=very well, 10 cm=very poorly). Participant's physical function and TJC were transformed on a 0-10 point scale, higher scores=more disease activity. PRO-CLARA total score=sum of scores of all 3 items divided by 3, range= 0-10, higher scores=more disease activity.
Time frame: Month 6
Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.
Primary
Patient's General Health Assessment at Month 12
Participants answered: How would you describe your general health today? Participants assessed their general health using a 0 - 10 cm VAS, where 0 cm = very well and 10 cm = very poor.
Time frame: Month 12
Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.
Primary
Patient's General Health Assessment at Month 6
Participants answered: How would you describe your general health today? Participants assessed their general health using a 0 - 10 cm VAS, where 0 cm = very well and 10 cm = very poor.
Time frame: Month 6
Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.
Primary
Percentage of Participants With Remission as Per Modified American College of Rheumatology (Modified ACR) Criteria at Month 12
Modified ACR: participant was considered in RA remission if at any time point 1) participant satisfied all of the following criteria: TJC \<=1; SJC \<=1 (TJC, SJC based on 28-joints); CRP \<=1 mg/dL; PtGA\<=1 (assessed on 0-10 centimeter\[cm\] visual analog scale\[VAS\]) or 2) participant had SDAI score of \<=3.3 (SDAI: the numerical sum of 5 outcome parameters: TJC, SJC, PtGA, PGA \[assessed on 0-10 cm VAS\], and CRP \[mg/dL\]).
Time frame: Month 12
Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.
Primary
Percentage of Participants With Remission as Per Modified American College of Rheumatology (Modified ACR) Criteria at Month 6
Modified ACR: participant considered in RA remission if at any time point 1) participant satisfied all of the following criteria: tender joint count(TJC) less than or equal to(\<=)1;swollen joint count(SJC)\<=1 (TJC, SJC based on 28-joints);C-reactive protein(CRP)\<=1 milligram/deciliter(mg/dL); patient global assessment (PtGA) \<=1 (assessed on 0-10 centimeter\[cm\] visual analog scale\[VAS\]) or 2) participant had Simplified Disease Activity Index score of \<=3.3 (SDAI, numerical sum of 5 outcome parameters: TJC, SJC, PtGA, physician global assessment \[PGA, assessed on 0-10 cm VAS\], and CRP \[mg/dL\]).
Time frame: Month 6
Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.
Primary
Physician Global Assessment (PGA) of Disease Activity at Month 12
Physician Global Assessment of Arthritis was measured on a 0 to 10 cm VAS, where 0 cm = very good and 10 cm = very bad.
Time frame: Month 12
Population: Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Physician Global Assessment (PGA) of Disease Activity at Month 12 | 2.60 cm | Standard Deviation 1.95 |
Primary
Physician Global Assessment (PGA) of Disease Activity at Month 6
Physician Global Assessment of Arthritis was measured on a 0 to 10 cm VAS, where 0 cm = very good and 10 cm = very bad.
Time frame: Month 6
Population: Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Physician Global Assessment (PGA) of Disease Activity at Month 6 | 3.11 cm | Standard Deviation 2.04 |
Primary
Radiological Assessment of Hands and Feet Based on Sharp-Van Der Hejde (SvH) Scoring Method at Month 12
SvH method included 16 areas for erosions and 15 areas for JSN and subluxation/luxation in each hand, 6 areas for erosions and 6 areas for JSN and subluxation/luxation in each foot. Erosion per joint scored on 0-5 point scale; 0=normal joint to 5=complete collapse. Total erosion score for hands:0-160, for feet:0-120. JSN and subluxation/luxation scored on 0-4 point scale; 0=normal joint to 4= a bony ankylosis/a complete luxation of joint. Total JSN and subluxation/luxation score for hands:0-120, for feet:0-48. Total SvH score = 0-448; higher score=more erosion and JSN.
Time frame: Month 12
Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.
Primary
Radiological Assessment of Hands and Feet Based on Sharp-van Der Hejde (SvH) Scoring Method at Month 6
SvH method included 16 areas for erosions and 15 areas for joint space narrowing (JSN) and subluxation/luxation in each hand, 6 areas for erosions and 6 areas for JSN and subluxation/luxation in each foot. Erosion per joint scored on 0-5 point scale; 0=normal joint to 5=complete collapse. Total erosion score for hands:0-160, for feet:0-120. JSN and subluxation/luxation scored on 0-4 point scale; 0=normal joint to 4= a bony ankylosis/a complete luxation of joint. Total JSN and subluxation/luxation score for hands:0-120, for feet:0-48. Total SvH score = 0-448; higher score=more erosion and JSN.
Time frame: Month 6
Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.
Primary
Recent-Onset Arthritis Disability (ROAD) at Month 12
ROAD questionnaire: valid and responsive tool for measuring functional ability in RA participants. Consists of 12-items related to fine movements of upper extremity, locomotor activities of lower extremity, and activities that involve both upper and lower extremities. For each item participant rated the level of difficulty over the past week on a 5-point scale ranging from 0 (without any difficulty) to 4 (unable to do). Total ROAD score were transformed to a 0 to 10 point scale, where 0 = best status and 10 = poorest status.
Time frame: Month 12
Population: Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Recent-Onset Arthritis Disability (ROAD) at Month 12 | 1.97 Units on a scale | Standard Deviation 1.92 |
Primary
Recent-Onset Arthritis Disability (ROAD) at Month 6
ROAD questionnaire: valid and responsive tool for measuring functional ability in RA participants. Consists of 12-items related to fine movements of upper extremity, locomotor activities of lower extremity, and activities that involve both upper and lower extremities. For each item participant rated the level of difficulty over the past week on a 5-point scale ranging from 0 (without any difficulty) to 4 (unable to do). Total ROAD score were transformed to a 0 to 10 point scale, where 0 = best status and 10 = poorest status.
Time frame: Month 6
Population: Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Recent-Onset Arthritis Disability (ROAD) at Month 6 | 2.28 Units on a scale | Standard Deviation 1.88 |
Primary
Rheumatoid Arthritis Disease Activity Index (RADAI) at Month 12
RADAI:self-assessed measure of disease activity in RA. Consists of 5 items: GDA in past 6 months; CDA as measured by SJC and TJC; current arthritis pain; current duration of morning stiffness; current TJC. GDA,CDA and pain were scored on an 11-point numerical rating scale,0=no disease activity/pain to 10=extreme disease activity/pain. Current morning stiffness and TJC were transformed to a 0-10 point scale,higher scores=more disease activity. RADAI total score=sum of individual items divided by 5;range 0-10, higher score=more disease activity.
Time frame: Month 12
Population: Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Rheumatoid Arthritis Disease Activity Index (RADAI) at Month 12 | 2.83 Units on a scale | Standard Deviation 1.89 |
Primary
Rheumatoid Arthritis Disease Activity Index (RADAI) at Month 6
RADAI:self-assessed measure of disease activity in RA. Consists of 5 items: global disease activity(GDA) in past 6 months; current disease activity(CDA) as measured by SJC and TJC; current arthritis pain; current duration of morning stiffness; current TJC. GDA,CDA and pain were scored on an 11-point numerical rating scale,0=no disease activity/pain to 10=extreme disease activity/pain. Current morning stiffness and TJC were transformed to a 0-10 point scale,higher scores=more disease activity. RADAI total score=sum of individual items divided by 5;range 0-10, higher score=more disease activity.
Time frame: Month 6
Population: Analysis population included all participants who were enrolled in the study. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Rheumatoid Arthritis Disease Activity Index (RADAI) at Month 6 | 3.26 Units on a scale | Standard Deviation 1.78 |
Primary
Simplified Disease Activity Index (SDAI) at Month 12
The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PGA (assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity), and CRP (mg/dL). SDAI total score= 0-86. SDAI \<=3.3 indicates disease remission, \>3.4 to 11 = low disease activity, \>11 to 26 = moderate disease activity, and \>26 = high disease activity.
Time frame: Month 12
Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.
Primary
Simplified Disease Activity Index (SDAI) at Month 6
The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PGA (assessed on 0-10 cm VAS; higher scores=greater affection due to disease activity), and CRP (mg/dL). SDAI total score= 0-86. SDAI \<=3.3 indicates disease remission, \>3.4 to 11 = low disease activity, \>11 to 26 = moderate disease activity, and \>26 = high disease activity.
Time frame: Month 6
Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.
Primary
Visual Analog Fatigue Scale (VAFS) at Month 12
Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.
Time frame: Month 12
Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.
Primary
Visual Analog Fatigue Scale (VAFS) at Month 6
Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.
Time frame: Month 6
Population: Data was not analyzed as per planned analysis because it was not considered significant to assess the outcome according to clinical opinion.