Rheumatoid Arthritis
Conditions
Brief summary
This prospective observational study will investigate the effect of tocilizumab on fatigue in participants with moderate to severe rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs or anti-tumour necrosis factor (anti-TNF) drugs. Data will be collected from participants for 6 months.
Interventions
DRUGTocilizumab
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants with moderate to severe RA who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab according to his/her clinical judgment and the conditions approved in the Summary of Product Characteristics (SPC).
Exclusion criteria
* Participants previously or currently treated with RoActemra/Actemra in clinical trials * Absolute neutrophil count less than or equal to (\</=) 2x10\^9 per liter (/L)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Regression Coefficient Between Change in Fatigue Score as Measured by the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) at Week 12 and Change in Main Variables at Week 12 | Week 12 | Regression analysis between change in FACIT-F scale and change in following variable were assessed: DAS28-ESR (total score range: 0-9.4, higher score=more disease activity), Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression). The total score of the FACIT-F questionnaire ranges from 0=worse score to 52=better score. Regression coefficient (R) and coefficient of determination (R\^2) were calculated. Difference (1-R\^2)=the variation in the changes in fatigue not explained by independent variables, that is, independent contribution of these changes in fatigue to the assessment of RA. Only variables with available data were reported. |
| Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 24 and Change in Main Variables at Week 24 | Week 24 | Regression analysis between change in FACIT-F scale and change in following variable were assessed: DAS28-ESR (total score range: 0-9.4, higher score=more disease activity), Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression). The total score of the FACIT-F questionnaire ranges from 0=worse score to 52=better score. Regression coefficient (R) and coefficient of determination (R\^2) were calculated. Difference (1-R\^2)=the variation in the changes in fatigue not explained by independent variables, that is, independent contribution of these changes in fatigue to the assessment of RA. Only variables with available data were reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 12 and 24 With Change in Disease Activity Parameters at Week 12 and 24 | Week 12, 24 | Regression analysis between change in FACIT-F scale and change in following variable were assessed: DAS28-ESR (total score range: 0-9.4, higher score=more disease activity), Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression), serum hemoglobin, swollen joint count, morning stiffness (time taken to achieve maximum improvement), degree of pain (assessed on horizontal visual scale, 0=no pain; 10=maximum pain). The total score of the FACIT-F questionnaire ranges from 0=worse score to 52=better score. Regression coefficient (R) and coefficient of determination (R\^2) were calculated. Difference (1-R\^2)=the variation in the changes in fatigue not explained by independent variables, that is, independent contribution of these changes in fatigue to the assessment of RA. Only variables with available data were reported. |
| Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24 | Week 12, 24 | Regression analysis between change in hemoglobin level and change in following variable were assessed: Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression), swollen joint count, morning stiffness (time taken to achieve maximum improvement), degree of pain (assessed on horizontal visual scale, 0=no pain; 10=maximum pain). Hemoglobin level was measure in g/L. The regression coefficient (R) and coefficient of determination (R\^2) were calculated. Difference (1-R\^2) indicates the variation in the changes in hemoglobin not explained by the independent variables, that is, independent contribution of these changes in hemoglobin to the assessment of RA. Only variables with available data were reported. |
| Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24 - Safety Population | Week 12, 24 | Regression analysis between change in hemoglobin level and change in following variable were assessed: Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression), swollen joint count, morning stiffness (time taken to achieve maximum improvement), degree of pain (assessed on horizontal visual scale, 0=no pain; 10=maximum pain). Hemoglobin level was measure in g/L. The regression coefficient (R) and coefficient of determination (R\^2) were calculated. Difference (1-R\^2) indicates the variation in the changes in hemoglobin not explained by the independent variables, that is, independent contribution of these changes in hemoglobin to the assessment of RA. Only variables with available data were reported. |
| Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in the Number of Swollen Joints (SJC 28) at Week 12 and 24 - Safety Population | Week 12, 24 | Regression analysis between the change in hemoglobin level and number of swollen joints was evaluated. Hemoglobin level was measure in g/L. The regression coefficient (R) and coefficient of determination (R\^2) were calculated. Difference (1-R\^2) indicates the variation in the changes in hemoglobin not explained by the independent variables, that is, independent contribution of these changes in hemoglobin to the assessment of RA. Only variables with available data were reported. |
| Change From Baseline in Number of Swollen Joint Count (SJC) at Week 12, 24 | Baseline, Week 12, Week 24 | Number of swollen joints was determined by examination of 66 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. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively. |
| Change From Baseline in Number of Swollen Joint Count (SJC) at Week 12, 24 - Safety Population | Baseline, Week 12, 24 | Number of swollen joints was determined by examination of 66 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. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively. |
| Change From Baseline in Duration of Morning Stiffness at Week 12, 24 | Baseline, Week 12, 24 | Duration of morning stiffness assessed as time taken to achieve maximum improvement from time participant rises. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively. |
| Change From Baseline in Duration of Morning Stiffness at Week 12, 24 - Safety Population | Baseline, Week 12, 24 | Duration of morning stiffness assessed as time taken to achieve maximum improvement from time participant rises. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively. |
| Change From Baseline in Pain Scores as Assessed by Visual Analogue Scale (VAS) at Week 12, 24 | Baseline, Week 12, 24 | Change from Baseline in 10 centimeter (cm) VAS pain score; 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Change = scores at observation minus score at Baseline. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively. |
| Change From Baseline to Week 12 and 24 in Fatigue Score as Assessed by FACIT-F | Baseline, Week 12, Week 24 | FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). |
| Change From Baseline in Sleepiness Score as Assessed on Epworth Sleepiness Scale at Week 12, 24 | Baseline, Week 12, 24 | Degree of sleepiness was assessed by Epworth Sleepiness Scale. The Epworth Sleepiness Scale evaluates how likely a person is to doze off or fall asleep in 8 different sedentary situations, using for each item possible scores of 0 to 3 (0=never, 1=mild, 2=moderate and 3=severe). A final score is obtained between 0-24, where a higher score indicates a higher degree of sleepiness. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively. |
| Change From Baseline in Sleepiness Score as Assessed on Epworth Sleepiness Scale at Week 12, 24 - Safety Population | Baseline, Week 12, 24 | Degree of sleepiness was assessed by Epworth Sleepiness Scale. The Epworth Sleepiness Scale evaluates how likely a person is to doze off or fall asleep in 8 different sedentary situations, using for each item possible scores of 0 to 3 (0=never, 1=mild, 2=moderate and 3=severe). A final score is obtained between 0-24, where a higher score indicates a higher degree of sleepiness. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively. |
| Change From Baseline in Depression Score as Assessed by the Beck Depression Inventory at Week 12, 24 | Baseline, Week 12, 24 | Mood assessed by the Beck Depression Inventory. The Beck Depression Inventory is a 21-item self-administered scale that evaluates severity of depression and is validated in Spanish on a 3 point scale (0=none to 3=severe). It measures the characteristic attitudes and symptoms of depression such as mood, pessimism, sense of failure, self-dissatisfaction, guilt, punishment, self-dislike, self-accusation, etc. The total score ranges from 0 to 63. A score higher than 18 indicates moderate to severe symptoms of depression. Analysis include only those participants who had available data at Weeks 12 and 24, respectively. |
| Change From Baseline in Depression Score as Assessed by the Beck Depression Inventory at Week 12, 24 - Safety Population | Baseline, Week 12, 24 | Mood assessed by the Beck Depression Inventory. The Beck Depression Inventory is a 21-item self-administered scale that evaluates severity of depression and is validated in Spanish on a 3 point scale (0=none to 3=severe). It measures the characteristic attitudes and symptoms of depression such as mood, pessimism, sense of failure, self-dissatisfaction, guilt, punishment, self-dislike, self-accusation, etc. The total score ranges from 0 to 63. A score higher than 18 indicates moderate to severe symptoms of depression. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively. |
| Change From Baseline in Disease Activity Scale (DAS28) Score at Week 12, 24 | Baseline, Week 12, 24 | DAS28-4 erythrocyte sedimentation rate (ESR) was calculated from SJC and tender joint count (TJC) using 28 joints count, ESR millimeter per hour (mm/hr) and patient global assessment (PtGA) of disease activity (participant rated arthritis activity assessment). The DAS28-ESR score (14) was calculated using the following formula: DAS28 = 0.56 x (square root TJC) + 0.28 x (square root SJC) + 0.70 x \[Ln(ESR)\] + 0.014 x (PtGA).Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) less than or equal to (\<=) 3.2 implied low disease activity and greater than (\>)3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) less than (\<)2.6 = remission. PtGA measured using a 100 mm VAS ranging from 0 = very good to 100 = very bad. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively. |
| Change From Baseline in Disease Activity Scale (DAS28) Score at Week 12, 24 - Safety Population | Baseline, Week 12, 24 | DAS28-4 ESR was calculated from SJC and TJC using 28 joints count, ESR mm/hr and PtGA of disease activity (participant rated arthritis activity assessment). The DAS28-ESR score (14) was calculated using the following formula: DAS28 = 0.56 x (square root TJC) + 0.28 x (square root SJC) + 0.70 x \[Ln(ESR)\] + 0.014 x (PtGA).Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) \<=3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \<2.6 = remission. PtGA measured using a 100 mm VAS ranging from 0 = very good to 100 = very bad. Analysis include only those participants who had available data at Weeks 12 and 24, respectively. |
| Percentage of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria at Week 12 and 24 | Week 12, 24 | Response was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 reduction from Baseline. Participants with a score \<=3.2 and reduction of \>1.2 points were assessed as having a 'good' response. Participants with a score \>3.2 with reduction of \>1.2 points, or a score \<=5.1 with reduction of \>0.6 to \<=1.2 points, were assessed as having a 'moderate' response. Participants with a score \>5.1 with reduction of \>0.6 to \<=1.2 points, or any score with reduction ≤0.6 points, were assessed as nonresponders with response recorded as 'none.' Participants with response is reported. DAS28 is described in outcome measure 19. |
| Percentage of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria at Week 12 and 24 - Safety Population | Week 12, 24 | Response was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 reduction from Baseline. Participants with a score \<=3.2 and reduction of \>1.2 points were assessed as having a 'good' response. Participants with a score \>3.2 with reduction of \>1.2 points, or a score \<=5.1 with reduction of \>0.6 to \<=1.2 points, were assessed as having a 'moderate' response. Participants with a score \>5.1 with reduction of \>0.6 to \<=1.2 points, or any score with reduction ≤0.6 points, were assessed as nonresponders with response recorded as 'none.' Participants with response is reported. DAS28 is described in outcome measure 19. |
| Change From Baseline in Pain Scores as Assessed by Visual Analogue Scale (VAS) at Week 12, 24 - Safety Population | Baseline, Week 12, 24 | Change from Baseline in 10 cm VAS pain score; 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Change = scores at observation minus score at Baseline. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively. |
| Change From Baseline to Week 12 and 24 in Serum Hemoglobin | Baseline, Week 12, 24 | The hemoglobin level was measured in grams per liter (g/L). Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively. |
Countries
Spain
Participant flow
Recruitment details
Total of 122 participants were recruited, 2 participants were excluded from analysis, one due to non-compliance with the inclusion criteria and other due to compliance with the exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Rheumatoid Arthritis Participants Participants with moderate to severe rheumatoid arthritis (RA) who had been considered and proposed by rheumatologist to start treatment with tocilizumab (RoActemra) according to the indications of the summary of product characteristics and the standard clinical practice of each participating center were followed-up for 6 months. | 120 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Abnormal laboratory parameters | 1 |
| Overall Study | Adverse Event | 5 |
| Overall Study | Lack of Efficacy | 4 |
| Overall Study | Other | 2 |
Baseline characteristics
| Characteristic | Rheumatoid Arthritis Participants |
|---|---|
| Age, Continuous | 52.2 years STANDARD_DEVIATION 12.6 |
| Sex: Female, Male Female | 104 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 27 / 120 |
| serious Total, serious adverse events | 3 / 120 |
Outcome results
Primary
Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 24 and Change in Main Variables at Week 24
Regression analysis between change in FACIT-F scale and change in following variable were assessed: DAS28-ESR (total score range: 0-9.4, higher score=more disease activity), Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression). The total score of the FACIT-F questionnaire ranges from 0=worse score to 52=better score. Regression coefficient (R) and coefficient of determination (R\^2) were calculated. Difference (1-R\^2)=the variation in the changes in fatigue not explained by independent variables, that is, independent contribution of these changes in fatigue to the assessment of RA. Only variables with available data were reported.
Time frame: Week 24
Population: Effectiveness analysis population. Here, N=number of participants evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 24 and Change in Main Variables at Week 24 | DAS-28 | -1.743 unstandardized regression coefficient |
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 24 and Change in Main Variables at Week 24 | Sleepiness | -0.990 unstandardized regression coefficient |
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 24 and Change in Main Variables at Week 24 | Depression | -0.658 unstandardized regression coefficient |
Comparison: change in fatigue score versus change in DAS-28 scorep-value: 0.023Regression, Linear
Comparison: change in fatigue score versus change in sleepiness scorep-value: 0.007Regression, Linear
Comparison: change in fatigue score versus change in depression scorep-value: 0Regression, Linear
Primary
Regression Coefficient Between Change in Fatigue Score as Measured by the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) at Week 12 and Change in Main Variables at Week 12
Regression analysis between change in FACIT-F scale and change in following variable were assessed: DAS28-ESR (total score range: 0-9.4, higher score=more disease activity), Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression). The total score of the FACIT-F questionnaire ranges from 0=worse score to 52=better score. Regression coefficient (R) and coefficient of determination (R\^2) were calculated. Difference (1-R\^2)=the variation in the changes in fatigue not explained by independent variables, that is, independent contribution of these changes in fatigue to the assessment of RA. Only variables with available data were reported.
Time frame: Week 12
Population: Effectiveness analysis population included all participants who had all measurements of effectiveness and had complete information of the FACIT questionnaire throughout the study. Here, Number of participants analyzed (N) = number of participants evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Fatigue Score as Measured by the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) at Week 12 and Change in Main Variables at Week 12 | DAS-28 | -2.200 unstandardized regression coefficient |
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Fatigue Score as Measured by the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) at Week 12 and Change in Main Variables at Week 12 | Sleepiness | -0.944 unstandardized regression coefficient |
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Fatigue Score as Measured by the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) at Week 12 and Change in Main Variables at Week 12 | Depression | -0.707 unstandardized regression coefficient |
Comparison: change in fatigue score versus change in DAS-28 scorep-value: 0.006Regression, Linear
Comparison: change in fatigue score versus change in sleepiness scorep-value: 0Regression, Linear
Comparison: change in fatigue score versus change in depression scorep-value: 0Regression, Linear
Secondary
Change From Baseline in Depression Score as Assessed by the Beck Depression Inventory at Week 12, 24
Mood assessed by the Beck Depression Inventory. The Beck Depression Inventory is a 21-item self-administered scale that evaluates severity of depression and is validated in Spanish on a 3 point scale (0=none to 3=severe). It measures the characteristic attitudes and symptoms of depression such as mood, pessimism, sense of failure, self-dissatisfaction, guilt, punishment, self-dislike, self-accusation, etc. The total score ranges from 0 to 63. A score higher than 18 indicates moderate to severe symptoms of depression. Analysis include only those participants who had available data at Weeks 12 and 24, respectively.
Time frame: Baseline, Week 12, 24
Population: Effectiveness analysis population. N=participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rheumatoid Arthritis Participants | Change From Baseline in Depression Score as Assessed by the Beck Depression Inventory at Week 12, 24 | Baseline for Week 12 | 17.4 score on a scale | Standard Deviation 11.7 |
| Rheumatoid Arthritis Participants | Change From Baseline in Depression Score as Assessed by the Beck Depression Inventory at Week 12, 24 | Change at Week 12 | 3.07 score on a scale | Standard Deviation 9.09 |
| Rheumatoid Arthritis Participants | Change From Baseline in Depression Score as Assessed by the Beck Depression Inventory at Week 12, 24 | Change at Week 24 | 3.5 score on a scale | Standard Deviation 8.99 |
Comparison: Baseline for Week 12 versus Week 12p-value: <0.001t-test, 2 sided
Comparison: Baseline for Week 24 versus Week 24p-value: <0.005t-test, 2 sided
Secondary
Change From Baseline in Depression Score as Assessed by the Beck Depression Inventory at Week 12, 24 - Safety Population
Mood assessed by the Beck Depression Inventory. The Beck Depression Inventory is a 21-item self-administered scale that evaluates severity of depression and is validated in Spanish on a 3 point scale (0=none to 3=severe). It measures the characteristic attitudes and symptoms of depression such as mood, pessimism, sense of failure, self-dissatisfaction, guilt, punishment, self-dislike, self-accusation, etc. The total score ranges from 0 to 63. A score higher than 18 indicates moderate to severe symptoms of depression. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.
Time frame: Baseline, Week 12, 24
Population: Safety population. N=participants who were evaluable for this outcome measure. n=number of participants evaluable in each category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rheumatoid Arthritis Participants | Change From Baseline in Depression Score as Assessed by the Beck Depression Inventory at Week 12, 24 - Safety Population | Baseline for Week 12 (n=111) | 18.3 score on a scale | Standard Deviation 12.6 |
| Rheumatoid Arthritis Participants | Change From Baseline in Depression Score as Assessed by the Beck Depression Inventory at Week 12, 24 - Safety Population | Change at Week 12 (n=111) | 3.5 score on a scale | Standard Deviation 9.4 |
| Rheumatoid Arthritis Participants | Change From Baseline in Depression Score as Assessed by the Beck Depression Inventory at Week 12, 24 - Safety Population | Baseline for Week 24 (n=113) | 18.5 score on a scale | Standard Deviation 12.7 |
| Rheumatoid Arthritis Participants | Change From Baseline in Depression Score as Assessed by the Beck Depression Inventory at Week 12, 24 - Safety Population | Change at Week 24 (n=113) | 3.89 score on a scale | Standard Deviation 11.7 |
Comparison: Baseline for Week 12 versus Week 12p-value: <0.001t-test, 2 sided
Comparison: Baseline for Week 24 versus Week 24p-value: <0.005t-test, 2 sided
Secondary
Change From Baseline in Disease Activity Scale (DAS28) Score at Week 12, 24
DAS28-4 erythrocyte sedimentation rate (ESR) was calculated from SJC and tender joint count (TJC) using 28 joints count, ESR millimeter per hour (mm/hr) and patient global assessment (PtGA) of disease activity (participant rated arthritis activity assessment). The DAS28-ESR score (14) was calculated using the following formula: DAS28 = 0.56 x (square root TJC) + 0.28 x (square root SJC) + 0.70 x \[Ln(ESR)\] + 0.014 x (PtGA).Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) less than or equal to (\<=) 3.2 implied low disease activity and greater than (\>)3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) less than (\<)2.6 = remission. PtGA measured using a 100 mm VAS ranging from 0 = very good to 100 = very bad. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.
Time frame: Baseline, Week 12, 24
Population: Effectiveness analysis: All participants who had at least one measurement of effectiveness subsequent to the start of tocilizumab (RoActemra) treatment were included. N=participants who were evaluable for this outcome measure. n=number of evaluable participants in each category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rheumatoid Arthritis Participants | Change From Baseline in Disease Activity Scale (DAS28) Score at Week 12, 24 | Baseline for Week 12 (n=66) | 3.0 score on a scale | Standard Deviation 1.2 |
| Rheumatoid Arthritis Participants | Change From Baseline in Disease Activity Scale (DAS28) Score at Week 12, 24 | Change at Week 12 (n=66) | 2.53 score on a scale | Standard Deviation 1.2 |
| Rheumatoid Arthritis Participants | Change From Baseline in Disease Activity Scale (DAS28) Score at Week 12, 24 | Baseline for Week 24 (n=71) | 2.7 score on a scale | Standard Deviation 1.3 |
| Rheumatoid Arthritis Participants | Change From Baseline in Disease Activity Scale (DAS28) Score at Week 12, 24 | Change at Week 24 (n=71) | 2.73 score on a scale | Standard Deviation 1.44 |
Comparison: Baseline for Week 12 versus Week 12p-value: <0.001t-test, 2 sided
Comparison: Baseline for Week 24 versus Week 24p-value: <0.001t-test, 2 sided
Secondary
Change From Baseline in Disease Activity Scale (DAS28) Score at Week 12, 24 - Safety Population
DAS28-4 ESR was calculated from SJC and TJC using 28 joints count, ESR mm/hr and PtGA of disease activity (participant rated arthritis activity assessment). The DAS28-ESR score (14) was calculated using the following formula: DAS28 = 0.56 x (square root TJC) + 0.28 x (square root SJC) + 0.70 x \[Ln(ESR)\] + 0.014 x (PtGA).Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) \<=3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \<2.6 = remission. PtGA measured using a 100 mm VAS ranging from 0 = very good to 100 = very bad. Analysis include only those participants who had available data at Weeks 12 and 24, respectively.
Time frame: Baseline, Week 12, 24
Population: Safety population. N=participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rheumatoid Arthritis Participants | Change From Baseline in Disease Activity Scale (DAS28) Score at Week 12, 24 - Safety Population | Baseline for Week 12 | 5.6 score on a scale | Standard Deviation 1 |
| Rheumatoid Arthritis Participants | Change From Baseline in Disease Activity Scale (DAS28) Score at Week 12, 24 - Safety Population | Change at Week 12 | 2.5 score on a scale | Standard Deviation 1.1 |
| Rheumatoid Arthritis Participants | Change From Baseline in Disease Activity Scale (DAS28) Score at Week 12, 24 - Safety Population | Change at Week 24 | 2.7 score on a scale | Standard Deviation 1.4 |
Secondary
Change From Baseline in Duration of Morning Stiffness at Week 12, 24
Duration of morning stiffness assessed as time taken to achieve maximum improvement from time participant rises. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.
Time frame: Baseline, Week 12, 24
Population: Effectiveness analysis population. N=participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rheumatoid Arthritis Participants | Change From Baseline in Duration of Morning Stiffness at Week 12, 24 | Baseline for Week 12 | 1.4 hours | Standard Deviation 2.7 |
| Rheumatoid Arthritis Participants | Change From Baseline in Duration of Morning Stiffness at Week 12, 24 | Change at Week 12 | 0.5 hours | Standard Deviation 0.9 |
| Rheumatoid Arthritis Participants | Change From Baseline in Duration of Morning Stiffness at Week 12, 24 | Baseline for Week 24 | 1.4 hours | Standard Deviation 2.8 |
| Rheumatoid Arthritis Participants | Change From Baseline in Duration of Morning Stiffness at Week 12, 24 | Change at Week 24 | 0.4 hours | Standard Deviation 0.9 |
Comparison: Baseline for Week 12 versus Week 12p-value: <0.001t-test, 2 sided
Comparison: Baseline for Week 24 versus Week 24p-value: <0.001t-test, 2 sided
Secondary
Change From Baseline in Duration of Morning Stiffness at Week 12, 24 - Safety Population
Duration of morning stiffness assessed as time taken to achieve maximum improvement from time participant rises. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.
Time frame: Baseline, Week 12, 24
Population: Safety population. N=participants who were evaluable for this outcome measure. n=number of participants evaluable in each category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rheumatoid Arthritis Participants | Change From Baseline in Duration of Morning Stiffness at Week 12, 24 - Safety Population | Baseline for Week 12 (n=109) | 1.4 hours | Standard Deviation 2.5 |
| Rheumatoid Arthritis Participants | Change From Baseline in Duration of Morning Stiffness at Week 12, 24 - Safety Population | Change at Week 12 (n=109) | 0.5 hours | Standard Deviation 0.8 |
| Rheumatoid Arthritis Participants | Change From Baseline in Duration of Morning Stiffness at Week 12, 24 - Safety Population | Baseline for Week 24 (n=112) | 1.4 hours | Standard Deviation 2.5 |
| Rheumatoid Arthritis Participants | Change From Baseline in Duration of Morning Stiffness at Week 12, 24 - Safety Population | Change at Week 24 (n=112) | 0.4 hours | Standard Deviation 0.8 |
Comparison: Baseline for Week 12 versus Week 12p-value: <0.001t-test, 2 sided
Comparison: Baseline for Week 24 versus Week 24p-value: <0.001t-test, 2 sided
Secondary
Change From Baseline in Number of Swollen Joint Count (SJC) at Week 12, 24
Number of swollen joints was determined by examination of 66 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. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.
Time frame: Baseline, Week 12, Week 24
Population: Effectiveness analysis population. N=participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rheumatoid Arthritis Participants | Change From Baseline in Number of Swollen Joint Count (SJC) at Week 12, 24 | Baseline for Week 12 | 5.9 swollen joints | Standard Deviation 4.6 |
| Rheumatoid Arthritis Participants | Change From Baseline in Number of Swollen Joint Count (SJC) at Week 12, 24 | Change at Week 12 | 1.9 swollen joints | Standard Deviation 3.5 |
| Rheumatoid Arthritis Participants | Change From Baseline in Number of Swollen Joint Count (SJC) at Week 12, 24 | Baseline for Week 24 | 6.0 swollen joints | Standard Deviation 4.6 |
| Rheumatoid Arthritis Participants | Change From Baseline in Number of Swollen Joint Count (SJC) at Week 12, 24 | Change at Week 24 | 1.8 swollen joints | Standard Deviation 3.5 |
Comparison: Baseline for Week 12 versus Week 12p-value: <0.001t-test, 2 sided
Comparison: Baseline for Week 24 versus Week 24p-value: <0.001t-test, 2 sided
Secondary
Change From Baseline in Number of Swollen Joint Count (SJC) at Week 12, 24 - Safety Population
Number of swollen joints was determined by examination of 66 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. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.
Time frame: Baseline, Week 12, 24
Population: Safety population. N=participants who were evaluable for this outcome measure. n=number of participants evaluable in each category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rheumatoid Arthritis Participants | Change From Baseline in Number of Swollen Joint Count (SJC) at Week 12, 24 - Safety Population | Baseline for Week 12 (n=109) | 5.7 swollen joints | Standard Deviation 4.2 |
| Rheumatoid Arthritis Participants | Change From Baseline in Number of Swollen Joint Count (SJC) at Week 12, 24 - Safety Population | Change at Week 12 (n=109) | 2.1 swollen joints | Standard Deviation 4.1 |
| Rheumatoid Arthritis Participants | Change From Baseline in Number of Swollen Joint Count (SJC) at Week 12, 24 - Safety Population | Baseline for Week 24 (n=113) | 5.9 swollen joints | Standard Deviation 4.3 |
| Rheumatoid Arthritis Participants | Change From Baseline in Number of Swollen Joint Count (SJC) at Week 12, 24 - Safety Population | Change at Week 24 (n=113) | 1.8 swollen joints | Standard Deviation 3.4 |
Comparison: Baseline for Week 12 versus Week 12p-value: <0.001t-test, 2 sided
Comparison: Baseline for Week 24 versus Week 24p-value: <0.001t-test, 2 sided
Secondary
Change From Baseline in Pain Scores as Assessed by Visual Analogue Scale (VAS) at Week 12, 24
Change from Baseline in 10 centimeter (cm) VAS pain score; 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Change = scores at observation minus score at Baseline. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.
Time frame: Baseline, Week 12, 24
Population: Effectiveness analysis population. N=participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rheumatoid Arthritis Participants | Change From Baseline in Pain Scores as Assessed by Visual Analogue Scale (VAS) at Week 12, 24 | Baseline for Week 12 | 6.8 centimeter | Standard Deviation 2.1 |
| Rheumatoid Arthritis Participants | Change From Baseline in Pain Scores as Assessed by Visual Analogue Scale (VAS) at Week 12, 24 | Change at Week 12 | 2.57 centimeter | Standard Deviation 2.52 |
| Rheumatoid Arthritis Participants | Change From Baseline in Pain Scores as Assessed by Visual Analogue Scale (VAS) at Week 12, 24 | Baseline for Week 24 | 6.8 centimeter | Standard Deviation 2.1 |
| Rheumatoid Arthritis Participants | Change From Baseline in Pain Scores as Assessed by Visual Analogue Scale (VAS) at Week 12, 24 | Change at Week 24 | 2.57 centimeter | Standard Deviation 2.95 |
Comparison: Baseline for Week 12 versus Week 12p-value: <0.001t-test, 2 sided
Comparison: Baseline for Week 24 versus Week 24p-value: <0.001t-test, 2 sided
Secondary
Change From Baseline in Pain Scores as Assessed by Visual Analogue Scale (VAS) at Week 12, 24 - Safety Population
Change from Baseline in 10 cm VAS pain score; 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Change = scores at observation minus score at Baseline. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.
Time frame: Baseline, Week 12, 24
Population: Safety population. N=participants who were evaluable for this outcome measure. n=number of participants evaluable in each category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rheumatoid Arthritis Participants | Change From Baseline in Pain Scores as Assessed by Visual Analogue Scale (VAS) at Week 12, 24 - Safety Population | Baseline for Week 12 (n=107) | 6.9 centimeter | Standard Deviation 2 |
| Rheumatoid Arthritis Participants | Change From Baseline in Pain Scores as Assessed by Visual Analogue Scale (VAS) at Week 12, 24 - Safety Population | Change at Week 12 (n=107) | 2.59 centimeter | Standard Deviation 2.5 |
| Rheumatoid Arthritis Participants | Change From Baseline in Pain Scores as Assessed by Visual Analogue Scale (VAS) at Week 12, 24 - Safety Population | Baseline for Week 24 (n=112) | 6.9 centimeter | Standard Deviation 2.1 |
| Rheumatoid Arthritis Participants | Change From Baseline in Pain Scores as Assessed by Visual Analogue Scale (VAS) at Week 12, 24 - Safety Population | Change at Week 24 (n=112) | 2.69 centimeter | Standard Deviation 2.97 |
Comparison: Baseline for Week 12 versus Week 12p-value: <0.001t-test, 2 sided
Comparison: Baseline for Week 24 versus Week 24p-value: <0.001t-test, 2 sided
Secondary
Change From Baseline in Sleepiness Score as Assessed on Epworth Sleepiness Scale at Week 12, 24
Degree of sleepiness was assessed by Epworth Sleepiness Scale. The Epworth Sleepiness Scale evaluates how likely a person is to doze off or fall asleep in 8 different sedentary situations, using for each item possible scores of 0 to 3 (0=never, 1=mild, 2=moderate and 3=severe). A final score is obtained between 0-24, where a higher score indicates a higher degree of sleepiness. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.
Time frame: Baseline, Week 12, 24
Population: Effectiveness analysis population. N=participants who were evaluable for this outcome measure. n=number of evaluable participants in each category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rheumatoid Arthritis Participants | Change From Baseline in Sleepiness Score as Assessed on Epworth Sleepiness Scale at Week 12, 24 | Change at Week 24 (n=83) | 5.3 score on a scale | Standard Deviation 4.4 |
| Rheumatoid Arthritis Participants | Change From Baseline in Sleepiness Score as Assessed on Epworth Sleepiness Scale at Week 12, 24 | Baseline for Week 12 (n=82) | 6.0 score on a scale | Standard Deviation 4.6 |
| Rheumatoid Arthritis Participants | Change From Baseline in Sleepiness Score as Assessed on Epworth Sleepiness Scale at Week 12, 24 | Change at Week 12 (n=82) | 5.4 score on a scale | Standard Deviation 5 |
| Rheumatoid Arthritis Participants | Change From Baseline in Sleepiness Score as Assessed on Epworth Sleepiness Scale at Week 12, 24 | Baseline for Week 24 (n=83) | 6.1 score on a scale | Standard Deviation 4.6 |
Comparison: Baseline for Week 12 versus Week 12p-value: 0.172t-test, 2 sided
Comparison: Baseline for Week 24 versus Week 24p-value: <0.05Regression, Logistic
Secondary
Change From Baseline in Sleepiness Score as Assessed on Epworth Sleepiness Scale at Week 12, 24 - Safety Population
Degree of sleepiness was assessed by Epworth Sleepiness Scale. The Epworth Sleepiness Scale evaluates how likely a person is to doze off or fall asleep in 8 different sedentary situations, using for each item possible scores of 0 to 3 (0=never, 1=mild, 2=moderate and 3=severe). A final score is obtained between 0-24, where a higher score indicates a higher degree of sleepiness. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.
Time frame: Baseline, Week 12, 24
Population: Safety population. N=participants who were evaluable for this outcome measure. n=number of participants evaluable in each category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rheumatoid Arthritis Participants | Change From Baseline in Sleepiness Score as Assessed on Epworth Sleepiness Scale at Week 12, 24 - Safety Population | Baseline for Week 12 (n=109) | 6.4 score on a scale | Standard Deviation 5 |
| Rheumatoid Arthritis Participants | Change From Baseline in Sleepiness Score as Assessed on Epworth Sleepiness Scale at Week 12, 24 - Safety Population | Change at Week 12 (n=109) | 6.0 score on a scale | Standard Deviation 4.4 |
| Rheumatoid Arthritis Participants | Change From Baseline in Sleepiness Score as Assessed on Epworth Sleepiness Scale at Week 12, 24 - Safety Population | Baseline for Week 24 (n=113) | 6.4 score on a scale | Standard Deviation 4.5 |
| Rheumatoid Arthritis Participants | Change From Baseline in Sleepiness Score as Assessed on Epworth Sleepiness Scale at Week 12, 24 - Safety Population | Change at Week 24 (n=113) | 5.4 score on a scale | Standard Deviation 4.5 |
Comparison: Baseline for Week 12 versus Week 12p-value: 0.162t-test, 2 sided
Comparison: Baseline for Week 12 versus Week 24p-value: <0.001t-test, 2 sided
Secondary
Change From Baseline to Week 12 and 24 in Fatigue Score as Assessed by FACIT-F
FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).
Time frame: Baseline, Week 12, Week 24
Population: Effectiveness analysis population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rheumatoid Arthritis Participants | Change From Baseline to Week 12 and 24 in Fatigue Score as Assessed by FACIT-F | Baseline | 26.8 units on a scale | Standard Deviation 12.4 |
| Rheumatoid Arthritis Participants | Change From Baseline to Week 12 and 24 in Fatigue Score as Assessed by FACIT-F | Change at Week 12 | 4.6 units on a scale | Standard Deviation 10.4 |
| Rheumatoid Arthritis Participants | Change From Baseline to Week 12 and 24 in Fatigue Score as Assessed by FACIT-F | Change at Week 24 | 5.4 units on a scale | Standard Deviation 11.2 |
Comparison: Baseline versus Week 12p-value: <0.001t-test, 2 sided
Comparison: Baseline versus Week 24p-value: <0.001t-test, 2 sided
Secondary
Change From Baseline to Week 12 and 24 in Serum Hemoglobin
The hemoglobin level was measured in grams per liter (g/L). Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.
Time frame: Baseline, Week 12, 24
Population: Effectiveness analysis population. N=participants who were evaluable for this outcome measure. n=number of evaluable participants for each category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rheumatoid Arthritis Participants | Change From Baseline to Week 12 and 24 in Serum Hemoglobin | Baseline for Week 12 (n=70) | 12.3 g/L | Standard Deviation 1.4 |
| Rheumatoid Arthritis Participants | Change From Baseline to Week 12 and 24 in Serum Hemoglobin | Change at Week 12 (n=70) | 0.7 g/L | Standard Deviation 1.2 |
| Rheumatoid Arthritis Participants | Change From Baseline to Week 12 and 24 in Serum Hemoglobin | Baseline for Week 24 (n=73) | 12.4 g/L | Standard Deviation 1.5 |
| Rheumatoid Arthritis Participants | Change From Baseline to Week 12 and 24 in Serum Hemoglobin | Change at Week 24 (n=73) | 0.56 g/L | Standard Deviation 1.1 |
Comparison: Baseline for Week 12 versus Week 12p-value: <0.001t-test, 2 sided
Comparison: Baseline for Week 24 versus Week 24p-value: <0.001t-test, 2 sided
Secondary
Percentage of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria at Week 12 and 24
Response was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 reduction from Baseline. Participants with a score \<=3.2 and reduction of \>1.2 points were assessed as having a 'good' response. Participants with a score \>3.2 with reduction of \>1.2 points, or a score \<=5.1 with reduction of \>0.6 to \<=1.2 points, were assessed as having a 'moderate' response. Participants with a score \>5.1 with reduction of \>0.6 to \<=1.2 points, or any score with reduction ≤0.6 points, were assessed as nonresponders with response recorded as 'none.' Participants with response is reported. DAS28 is described in outcome measure 19.
Time frame: Week 12, 24
Population: Effectiveness analysis population. N=participants who were evaluable for this outcome measure. n=number of evaluable participants in each category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rheumatoid Arthritis Participants | Percentage of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria at Week 12 and 24 | Good response at Week 12 (n=66) | 56.1 percentage of participants |
| Rheumatoid Arthritis Participants | Percentage of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria at Week 12 and 24 | Good response at Week 24 (n=71) | 62.0 percentage of participants |
| Rheumatoid Arthritis Participants | Percentage of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria at Week 12 and 24 | Moderate or good response at Week 12 (n=66) | 95.5 percentage of participants |
| Rheumatoid Arthritis Participants | Percentage of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria at Week 12 and 24 | Moderate or good response at Week 24 (n=71) | 93.0 percentage of participants |
Secondary
Percentage of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria at Week 12 and 24 - Safety Population
Response was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 reduction from Baseline. Participants with a score \<=3.2 and reduction of \>1.2 points were assessed as having a 'good' response. Participants with a score \>3.2 with reduction of \>1.2 points, or a score \<=5.1 with reduction of \>0.6 to \<=1.2 points, were assessed as having a 'moderate' response. Participants with a score \>5.1 with reduction of \>0.6 to \<=1.2 points, or any score with reduction ≤0.6 points, were assessed as nonresponders with response recorded as 'none.' Participants with response is reported. DAS28 is described in outcome measure 19.
Time frame: Week 12, 24
Population: Safety population. N=participants who were evaluable for this outcome measure. n=number of evaluable participants in each category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rheumatoid Arthritis Participants | Percentage of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria at Week 12 and 24 - Safety Population | Good response at Week 12 (n=85) | 51 percentage of participants |
| Rheumatoid Arthritis Participants | Percentage of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria at Week 12 and 24 - Safety Population | Good response at Week 24 (n=92) | 61 percentage of participants |
| Rheumatoid Arthritis Participants | Percentage of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria at Week 12 and 24 - Safety Population | Moderate or good response at Week 12 (n=85) | 95.3 percentage of participants |
| Rheumatoid Arthritis Participants | Percentage of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria at Week 12 and 24 - Safety Population | Moderate or good response at Week 24 (n=92) | 94.6 percentage of participants |
Secondary
Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 12 and 24 With Change in Disease Activity Parameters at Week 12 and 24
Regression analysis between change in FACIT-F scale and change in following variable were assessed: DAS28-ESR (total score range: 0-9.4, higher score=more disease activity), Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression), serum hemoglobin, swollen joint count, morning stiffness (time taken to achieve maximum improvement), degree of pain (assessed on horizontal visual scale, 0=no pain; 10=maximum pain). The total score of the FACIT-F questionnaire ranges from 0=worse score to 52=better score. Regression coefficient (R) and coefficient of determination (R\^2) were calculated. Difference (1-R\^2)=the variation in the changes in fatigue not explained by independent variables, that is, independent contribution of these changes in fatigue to the assessment of RA. Only variables with available data were reported.
Time frame: Week 12, 24
Population: Effectiveness analysis population. Here, N=number of participants analyzed for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 12 and 24 With Change in Disease Activity Parameters at Week 12 and 24 | DAS-28 (Week 12) | -3.241 unstandardized regression coefficient |
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 12 and 24 With Change in Disease Activity Parameters at Week 12 and 24 | DAS-28 (Week 24) | -2.596 unstandardized regression coefficient |
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 12 and 24 With Change in Disease Activity Parameters at Week 12 and 24 | Serum hemoglobin (Week 12) | 0.335 unstandardized regression coefficient |
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 12 and 24 With Change in Disease Activity Parameters at Week 12 and 24 | Serum hemoglobin (Week 24) | -0.242 unstandardized regression coefficient |
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 12 and 24 With Change in Disease Activity Parameters at Week 12 and 24 | Swollen joint count (Week 12) | -0.333 unstandardized regression coefficient |
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 12 and 24 With Change in Disease Activity Parameters at Week 12 and 24 | Swollen joint count (Week 24) | -0.600 unstandardized regression coefficient |
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 12 and 24 With Change in Disease Activity Parameters at Week 12 and 24 | Morning stiffness (Week 12) | -0.559 unstandardized regression coefficient |
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 12 and 24 With Change in Disease Activity Parameters at Week 12 and 24 | Morning stiffness (Week 24) | -0.718 unstandardized regression coefficient |
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 12 and 24 With Change in Disease Activity Parameters at Week 12 and 24 | Degree of pain (Week 12) | -0.947 unstandardized regression coefficient |
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 12 and 24 With Change in Disease Activity Parameters at Week 12 and 24 | Degree of pain (Week 24) | -0.839 unstandardized regression coefficient |
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 12 and 24 With Change in Disease Activity Parameters at Week 12 and 24 | Sleepiness (Week 12) | -0.742 unstandardized regression coefficient |
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 12 and 24 With Change in Disease Activity Parameters at Week 12 and 24 | Sleepiness (Week 24) | 1.193 unstandardized regression coefficient |
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 12 and 24 With Change in Disease Activity Parameters at Week 12 and 24 | Depression (Week 12) | -0.714 unstandardized regression coefficient |
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 12 and 24 With Change in Disease Activity Parameters at Week 12 and 24 | Depression (Week 24) | -0.777 unstandardized regression coefficient |
Comparison: change in fatigue score at Week 12 versus change in DAS-28 at Week 12p-value: 0.003Regression, Linear
Comparison: change in fatigue score at Week 24 versus change in DAS-28 at Week 24p-value: 0.006Regression, Linear
Comparison: change in fatigue score at Week 12 versus change in serum hemoglobin Week 12p-value: 0.791Regression, Linear
Comparison: change in fatigue score at Week 24 versus change in serum hemoglobin Week 24p-value: 0.847Regression, Linear
Comparison: change in fatigue score at Week 12 versus change in swollen joint count Week 12p-value: 0.182Regression, Linear
Comparison: change in fatigue score at Week 24 versus change in swollen joint count Week 24p-value: 0.022Regression, Linear
Comparison: change in fatigue score at Week 12 versus change in morning stiffness Week 12p-value: 0.163Regression, Linear
Comparison: change in fatigue score at Week 24 versus change in morning stiffness Week 24p-value: 0.115Regression, Linear
Comparison: change in fatigue score at Week 12 versus change in degree of pain Week 12p-value: 0.037Regression, Linear
Comparison: change in fatigue score at Week 24 versus change in degree of pain Week 24p-value: 0.044Regression, Linear
Comparison: change in fatigue score at Week 12 versus change in sleepiness at Week 12p-value: 0.003Regression, Linear
Comparison: change in fatigue score at Week 24 versus change in sleepiness at Week 24p-value: 0.001Regression, Linear
Comparison: change in fatigue score at Week 12 versus change in depression Week 12p-value: <0.001Regression, Linear
Comparison: change in fatigue score at Week 24 versus change in depression at Week 24p-value: <0.001Regression, Linear
Secondary
Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24
Regression analysis between change in hemoglobin level and change in following variable were assessed: Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression), swollen joint count, morning stiffness (time taken to achieve maximum improvement), degree of pain (assessed on horizontal visual scale, 0=no pain; 10=maximum pain). Hemoglobin level was measure in g/L. The regression coefficient (R) and coefficient of determination (R\^2) were calculated. Difference (1-R\^2) indicates the variation in the changes in hemoglobin not explained by the independent variables, that is, independent contribution of these changes in hemoglobin to the assessment of RA. Only variables with available data were reported.
Time frame: Week 12, 24
Population: Effectiveness analysis population. N=number of participants analyzed for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24 | Swollen joint count (Week 12) | -0.011 unstandardized regression coefficient |
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24 | Swollen joint count (Week 24) | 0.028 unstandardized regression coefficient |
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24 | Morning stiffness (Week 12) | 0.017 unstandardized regression coefficient |
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24 | Morning stiffness (Week 24) | -0.055 unstandardized regression coefficient |
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24 | Degree of pain (Week 12) | 0.021 unstandardized regression coefficient |
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24 | Degree of pain (Week 24) | 0.013 unstandardized regression coefficient |
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24 | Sleepiness (Week 12) | 0.004 unstandardized regression coefficient |
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24 | Sleepiness (Week 24) | 0.062 unstandardized regression coefficient |
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24 | Depression (Week 12) | -0.016 unstandardized regression coefficient |
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24 | Depression (Week 24) | -0.007 unstandardized regression coefficient |
Comparison: change in hemoglobin levels versus change in swollen joint count (Week 12)p-value: 0.678Regression, Linear
Comparison: change in hemoglobin levels versus change in swollen joint count (Week 24)p-value: 0.348Regression, Linear
Comparison: change in hemoglobin levels versus change in morning stiffness (Week 12)p-value: 0.679Regression, Linear
Comparison: change in hemoglobin levels versus change in morning stiffness (Week 24)p-value: 0.556Regression, Linear
Comparison: change in haemoglobin levels versus change in degree of pain (Week 12)p-value: 0.692Regression, Linear
Comparison: change in haemoglobin levels versus change in degree of pain (Week 24)p-value: 0.771Regression, Linear
Comparison: change in haemoglobin levels versus change in sleepiness (Week 12)p-value: 0.878Regression, Linear
Comparison: change in haemoglobin levels versus change in sleepiness (Week 24)p-value: 0.139Regression, Linear
Comparison: change in haemoglobin levels versus change in depression score (Week 12)p-value: 0.249Regression, Linear
Comparison: change in hemoglobin levels versus change in depression score (Week 24)p-value: 0.61Regression, Linear
Secondary
Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24 - Safety Population
Regression analysis between change in hemoglobin level and change in following variable were assessed: Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression), swollen joint count, morning stiffness (time taken to achieve maximum improvement), degree of pain (assessed on horizontal visual scale, 0=no pain; 10=maximum pain). Hemoglobin level was measure in g/L. The regression coefficient (R) and coefficient of determination (R\^2) were calculated. Difference (1-R\^2) indicates the variation in the changes in hemoglobin not explained by the independent variables, that is, independent contribution of these changes in hemoglobin to the assessment of RA. Only variables with available data were reported.
Time frame: Week 12, 24
Population: Safety analysis population. Here, N=number of participants analyzed for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24 - Safety Population | Swollen joint count (Week 12) | 0.025 unstandardized regression coefficient |
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24 - Safety Population | Swollen joint count (Week 24) | 0.018 unstandardized regression coefficient |
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24 - Safety Population | Morning stiffness (Week 12) | 0.019 unstandardized regression coefficient |
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24 - Safety Population | Morning stiffness (Week 24) | -0.05 unstandardized regression coefficient |
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24 - Safety Population | Degree of pain (Week 12) | 0.022 unstandardized regression coefficient |
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24 - Safety Population | Degree of pain (Week 24) | 0.012 unstandardized regression coefficient |
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24 - Safety Population | Sleepiness (Week 24) | 0.059 unstandardized regression coefficient |
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24 - Safety Population | Depression (Week 12) | -0.02 unstandardized regression coefficient |
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24 - Safety Population | Depression (Week 24) | -0.016 unstandardized regression coefficient |
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24 - Safety Population | Sleepiness (Week 12) | 0.002 unstandardized regression coefficient |
Comparison: change in haemoglobin levels versus change in swollen joint count (Week 12)p-value: 0.257Regression, Linear
Comparison: change in haemoglobin levels versus change in swollen joint count (Week 24)p-value: 0.487Regression, Linear
Comparison: change in hemoglobin levels versus change in morning stiffness (Week 12)p-value: 0.644Regression, Linear
Comparison: change in hemoglobin levels versus change in morning stiffness (Week 24)p-value: 0.498Regression, Linear
Comparison: change in hemoglobin levels versus change in degree of pain (Week 12)p-value: 0.65Regression, Linear
Comparison: change in hemoglobin levels versus change in degree of pain (Week 24)p-value: 0.75Regression, Cox
Comparison: change in hemoglobin levels versus change in sleepiness (Week 12)p-value: 0.936Regression, Linear
Comparison: change in hemoglobin levels versus change in sleepiness (Week 24)p-value: 0.075Regression, Linear
Comparison: change in hemoglobin levels versus change in depression score (Week 12)p-value: 0.098Regression, Linear
Comparison: change in hemoglobin levels versus change in depression score (Week 24)p-value: 0.09Regression, Linear
Secondary
Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in the Number of Swollen Joints (SJC 28) at Week 12 and 24 - Safety Population
Regression analysis between the change in hemoglobin level and number of swollen joints was evaluated. Hemoglobin level was measure in g/L. The regression coefficient (R) and coefficient of determination (R\^2) were calculated. Difference (1-R\^2) indicates the variation in the changes in hemoglobin not explained by the independent variables, that is, independent contribution of these changes in hemoglobin to the assessment of RA. Only variables with available data were reported.
Time frame: Week 12, 24
Population: Safety analysis population. N=participants who were evaluable for this outcome measure. n=number of participants evaluable in each category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in the Number of Swollen Joints (SJC 28) at Week 12 and 24 - Safety Population | Week 12 (n=91) | 0.186 unstandardized regression coefficient |
| Rheumatoid Arthritis Participants | Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in the Number of Swollen Joints (SJC 28) at Week 12 and 24 - Safety Population | Week 24 (n=98) | 0.005 unstandardized regression coefficient |
Comparison: change in hemoglobin levels versus change in swollen joint count (Week 12)p-value: 0.077Multiple Regression
Comparison: change in hemoglobin levels versus change in swollen joint count (Week 24)p-value: 0.961Multiple Regression