Rheumatoid Arthritis
Conditions
Brief summary
This single arm study will assess the effect of tocilizumab + DMARDs (Disease Modifying Anti-Rheumatic Drugs)on improvement of anemia and fatigue in patients with moderate to severe active rheumatoid arthritis. Eligible patients who have had an inadequate response to DMARDs will receive tocilizumab 8mg/kg iv every 4 weeks in combination with standard DMARDs, for 6 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Interventions
DRUGtocilizumab [RoActemra/Actemra]
8mg/kg iv every 4 weeks for 6 months
DRUGStandard DMARDs (Disease Modifying Anti Rheumatic Drugs)
As prescribed
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients, \>=18 years of age; * rheumatoid arthritis \>=6 months duration; * DAS28\>=3.2; * inadequate response to prior treatment with a stable dose (\>=8 weeks) of DMARD therapy.
Exclusion criteria
* rheumatic autoimmune disease other than rheumatoid arthritis; * history of or current inflammatory joint disease other than rheumatoid arthritis; * unsuccessful treatment with an anti-TNF agent; * previous/concurrent treatment with any cell-depleting therapies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of Anemia at Week 4 Assessed as Change From Baseline in Hemoglobin | Week 4 | Hemoglobin levels were measured as grams/deciliter (g/dL). |
| Improvement in Fatigue at Week 4 Assessed as Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scores | Week 4 | The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants 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). Clinically relevant improvement is defined as a greater than or equal to (≥)5-point change from Baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FACIT-F Scores | Baseline, Weeks 2, 4, 8,12, 16, 20 and 24 | The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants 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). Clinically relevant improvement is defined as a ≥5-point change from Baseline. |
| Improvement of Fatigue Assessed as Change From Baseline in FACIT-F Scores | Weeks 2, 4, 8, 12, 16, 20 and 24 | The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants 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). Clinically relevant improvement is defined as a ≥5-point change from Baseline. |
| Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50% or 70% Improvement | Week 24 | The ACR response rates ACR20, ACR50, and ACR70 were defined as ≥20%, ≥50% and ≥ 70% improvement, respectively, in: swollen joint count (SJC) (66 joints) and tender joint count (TJC) (68 joints) and 3 of the 5 remaining ACR parameters: Patient assessment of pain; Patient Global Assessment of Disease Activity; Investigator Global Assessment of Disease Activity; participant self-rated assessment of disability measured by the Health Assessment Questionnaire Disability Index (HAQ-DI); and acute phase response (erythrocyte sedimentation rate \[ESR\] or C-reactive protein \[CRP\]). |
| Percent Change From Baseline to Week 24 in TJC | Week 24 | Sixty-eight (68) joints were assessed at each visit for tenderness; joints were assessed and classified as tender/not tender. Tender joint count 68 (TJC-68) was calculated as the number of tender joints from 68 joints; the number of tender joints was summed (maximum score 68). Calculated values were used for the analysis. A negative score indicated improvement. |
| Percent Change From Baseline to Week 24 in SJC | Week 24 | Sixty-six (66) joints were assessed at each visit for swelling; joints were assessed and classified as swollen/not swollen. Swollen joint count 66 (SJC-66) was calculated as the number of swollen joints from 66 joints; the number of swollen joints was summed (maximum score 66). Calculated values were used for the analysis. A negative score indicated improvement. |
| Percent Change From Baseline to Week 24 in Patient Global Assessment of Pain | Week 24 | The participant's assessment of their current level of pain was displayed on a 100-millimeter (mm) horizontal visual analog scale (VAS). The left-hand extreme of the line was described as no pain and the right-hand as unbearable pain. The participant was asked to mark the line that corresponded to their current level of pain; the distance from the left edge was recorded. |
| Percent Change From Baseline to Week 24 in Patient's Global Assessment of Disease Activity | Week 24 | The participant's overall assessment of their current disease activity was displayed on a 100-mm horizontal VAS. The left-hand extreme of the line was described as no disease activity (symptom free and no arthritis symptoms) and the right-hand extreme as maximum disease activity (maximum arthritis disease activity). Participants were asked to assess their current level of disease activity and mark the line; the distance from the left edge was recorded. |
| Percent Change From Baseline to Week 24 in Investigator's Global Assessment of Disease Activity | Week 24 | The physician's assessment of the participant's current disease activity was displayed on a 100-mm horizontal VAS. The left-hand extreme of the line was described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme was considered maximum disease activity. The physician's global assessment of disease activity was completed by the Efficacy Assessor who could or could not be a physician. The assessor was asked to mark the line corresponding to their assessment of the participant's present level of disease activity; the distance from the left edge was recorded. |
| Percent Change From Baseline to Week 24 in HAQ-DI | Week 24 | HAQ-DI includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Overall score was computed as the sum of the domain scores and divided by the number of domains answered. Total possible score range was 0-3 where 0 (equals)=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. |
| Percent Change From Baseline to Week 24 in High-Sensitivity CRP (Hs-CRP) | Week 24 | hs-CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). hsCRP is measured in milligrams per liter (mg/L). |
| Percent Change From Baseline to Week 24 in ESR | Week 24 | ESR is a blood test used to monitor therapy in inflammatory diseases such as RA and reflects acute phase reactant levels. ESR is measured in mm per hour (mm/hr); active disease in RA is defined by an ESR greater than 30 mm/hr. |
| Mean Hemoglobin Levels During the Study | Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24 | — |
| Percentage of Participants With a Response at Week 24 by DAS28 Category | Week 24 | DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the ESR (mm/hr) and patient's global assessment of disease activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2=low disease activity, DAS28 \>5.1=high disease activity and DAS \<2.6=remission. |
| Percent Change From Baseline to Week 24 in DAS28 Score | Week 24 | DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the ESR (mm/hr) and patient's global assessment of disease activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2=low disease activity, DAS28 \>5.1=high disease activity and DAS \<2.6=remission. |
| Percentage of Participants With an Improvement of ≥1 g/dL in Hemoglobin | Week 24 | — |
| Number of Days as Assessed by Short Form-Health and Labour Questionnaire (SF-HLQ) | Baseline | The SF-HLQ assessed productivity losses related to health problems in individuals with paid or unpaid work and consists of three modules (absenteeism from paid work, production losses without absenteeism from paid work and hindrance in the performance of paid and unpaid work). Any missed working days or number of worked days with reduced efficiency during the last month were reported. |
| Change From Baseline to Weeks 12 and 24 in Number of Days as Assessed by SF-HLQ | Weeks 12 and 24 | The SF-HLQ assessed productivity losses related to health problems in individuals with paid or unpaid work and consists of three modules (absenteeism from paid work, production losses without absenteeism from paid work and hindrance in the performance of paid and unpaid work). Any missed working days or number of worked days with reduced efficiency during the last month were reported. |
| Number of Hours as Assessed by SF-HLQ | Baseline | Number of working hours lost, and number of hours of support in in taking over and performing usual household tasks in the last month: chores done by family members, chores done by other persons receiving no pay, home care, other paid care, total number of unpaid hours, and total number of hours during the last month were reported. |
| Change From Baseline to Weeks 12 and 24 in Number of Hours as Assessed by SF-HLQ | Baseline | Number of working hours lost, and number of hours of support in in taking over and performing usual household tasks in the last month: chores done by family members, chores done by other persons receiving no pay, home care, other paid care, total number of unpaid hours, and total number of hours during the last month were reported. Changes from baseline were only calculated in participants who completed the questionnaire at all times (baseline, Week 12, and Week 24). Negative number indicates improvement. |
| SF-HLQ Hindrance Score | Baseline | Participants were asked if their health problems hindered their paid work on a scale of 1 to 3 (1=no, 2=yes, slightly, 3=yes, very much) and their unpaid work including household work, going shopping, odd jobs, specific activities sharing the household on a scale of 0 to 3 (0=performed without being bothered by healthy problems; 1=performed although bothered by health problems; 2=not performed because of health problems; 3=not performed for reasons other than health problems). The total hindrance score for unpaid work was derived by adding up the item scores. This hindrance score is a measure of the hindrance experienced as a result of health problems during the performance of unpaid work. The minimum score per item for hindrance score was 0, maximum score was 2 (Score of 3 was not considered since the reasons were other than health problems). Total score was calculated by adding all 4 items together and ranged from 0 (best possible score) to 8 (worst possible score). |
| Change From Baseline to Weeks 12 and 24 SF-HLQ Hindrance Score | Baseline | Participants were asked if health problems hindered their paid work on a scale of 1 to 3 (1=no, 2=yes, slightly, 3=yes, very much) and their unpaid work including household work, going shopping, odd jobs, specific activities sharing the household on a scale of 0 to 3 (0=performed without being bothered by healthy problems; 1=performed although bothered by health problems; 2=not performed because of health problems; 3=not performed for reasons other than health problems). Hindrance score is a measure of the hindrance experienced as a result of health problems during the performance of unpaid work. The minimum score per item for hindrance score was 0, maximum score was 2 (Score of 3 was not considered since the reasons were other than health problems). Total score was calculated by adding all 4 items together and ranged from 0 (best possible score) to 8 (worst possible score). A negative change from baseline indicates improvement. |
| Efficiency as Assessed by SF-HLQ | Baseline | Participants were ask to rate their efficiency in working on a scale of of 0 to 10 (0=very worse, 10=as usual). Overall efficiency score was based on the first 6 items of Question 6, which is a descriptive instrument comprised of 7 items designed to evaluate the specific problems affecting production. These 7 items relate to the effect of health problems on concentration, work pace, the need to be alone, making decisions, postponing and transferring work to others. The participant can choose from 4 possible answers: (almost) never, sometimes, often and (nearly) always. Efficiency score range=6 to 24; higher scores indicate higher impairment. |
| Change From Baseline to Weeks 12 and 24 in Efficiency as Assessed by SF-HLQ | Baseline | Participants were ask to rate their efficiency in working on a scale of of 0 to 10 (0=very worse, 10=as usual). Overall efficiency score was based on the first 6 items of Question 6, which is a descriptive instrument comprised of 7 items designed to evaluate the specific problems affecting production. These 7 items relate to the effect of health problems on concentration, work pace, the need to be alone, making decisions, postponing and transferring work to others. The participant can choose from 4 possible answers: (almost) never, sometimes, often and (nearly) always. Efficiency score range=6 to 24; higher scores indicate higher impairment. Change from baseline was only calculated for participants who completed the questionnaire at all times (baseline, Week 12 and Week 24). A negative change from baseline indicates improvement. |
| Percentage of Participants With a Response at Week 24 by European League Against Rheumatism (EULAR) Category | Week 24 | Disease response was assessed using EULAR Disease Activity Score Based on 28-Joint Count (DAS28) categories of Good, Moderate, or No Response. Good response was defined as a DAS28 score of less than (\<)3.2 and improvement from baseline of \>1.2; Moderate response was defined as a DAS28 score of 3.2-5.1 and improvement from baseline of 1.2-0.6 or a DAS28 score of \>5.1 and improvement from baseline of \>1.2; No response was defined as a DAS28 score of \>5.1 and improvement from baseline of \<1.2. Participants who discontinued prematurely were identified as non-responders. |
| Improvement of Anemia Assessed as Change From Baseline in Hemoglobin | Weeks 2, 4, 8, 12, 16, 20, and 24 | Improvement of anemia was evaluated as change in hemoglobin levels from baseline. |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tocilizumab 8 mg/kg Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions. | 105 |
| Total | 105 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Administrative Reason | 1 |
| Overall Study | Adverse Event | 7 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Tocilizumab 8 mg/kg |
|---|---|
| Age, Continuous | 55.0 years STANDARD_DEVIATION 12.8 |
| Sex: Female, Male Female | 89 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 | 64 / 105 |
| serious Total, serious adverse events | 4 / 105 |
Outcome results
Primary
Improvement in Fatigue at Week 4 Assessed as Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scores
The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants 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). Clinically relevant improvement is defined as a greater than or equal to (≥)5-point change from Baseline.
Time frame: Week 4
Population: ITT population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tocilizumab 8 mg/kg | Improvement in Fatigue at Week 4 Assessed as Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scores | 8.76 units on a scale | Standard Deviation 8.83 |
Primary
Improvement of Anemia at Week 4 Assessed as Change From Baseline in Hemoglobin
Hemoglobin levels were measured as grams/deciliter (g/dL).
Time frame: Week 4
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tocilizumab 8 mg/kg | Improvement of Anemia at Week 4 Assessed as Change From Baseline in Hemoglobin | 0.40 g/dL | Standard Deviation 0.78 |
Secondary
Change From Baseline to Weeks 12 and 24 in Efficiency as Assessed by SF-HLQ
Participants were ask to rate their efficiency in working on a scale of of 0 to 10 (0=very worse, 10=as usual). Overall efficiency score was based on the first 6 items of Question 6, which is a descriptive instrument comprised of 7 items designed to evaluate the specific problems affecting production. These 7 items relate to the effect of health problems on concentration, work pace, the need to be alone, making decisions, postponing and transferring work to others. The participant can choose from 4 possible answers: (almost) never, sometimes, often and (nearly) always. Efficiency score range=6 to 24; higher scores indicate higher impairment. Change from baseline was only calculated for participants who completed the questionnaire at all times (baseline, Week 12 and Week 24). A negative change from baseline indicates improvement.
Time frame: Baseline
Population: ITT population; n=number of participants assessed for the specified parameter.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab 8 mg/kg | Change From Baseline to Weeks 12 and 24 in Efficiency as Assessed by SF-HLQ | Efficiency in working, Week 12 (n=21) | 2.0 units on a scale | Standard Deviation 2.3 |
| Tocilizumab 8 mg/kg | Change From Baseline to Weeks 12 and 24 in Efficiency as Assessed by SF-HLQ | Efficiency in working, Week 24 (n=21) | 2.2 units on a scale | Standard Deviation 2.4 |
| Tocilizumab 8 mg/kg | Change From Baseline to Weeks 12 and 24 in Efficiency as Assessed by SF-HLQ | Efficiency score, Week 12 (n=24) | -2.3 units on a scale | Standard Deviation 3 |
| Tocilizumab 8 mg/kg | Change From Baseline to Weeks 12 and 24 in Efficiency as Assessed by SF-HLQ | Efficiency score, Week 24 (n=24) | -2.7 units on a scale | Standard Deviation 3 |
Secondary
Change From Baseline to Weeks 12 and 24 in Number of Days as Assessed by SF-HLQ
The SF-HLQ assessed productivity losses related to health problems in individuals with paid or unpaid work and consists of three modules (absenteeism from paid work, production losses without absenteeism from paid work and hindrance in the performance of paid and unpaid work). Any missed working days or number of worked days with reduced efficiency during the last month were reported.
Time frame: Weeks 12 and 24
Population: ITT population; n=number of participants assessed for the specified parameter.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab 8 mg/kg | Change From Baseline to Weeks 12 and 24 in Number of Days as Assessed by SF-HLQ | Missed working days, Week 12 (n=25) | -3.5 days | Standard Deviation 5.1 |
| Tocilizumab 8 mg/kg | Change From Baseline to Weeks 12 and 24 in Number of Days as Assessed by SF-HLQ | Days with reduced capacity, Week 12 (n=19) | -4.2 days | Standard Deviation 10.9 |
| Tocilizumab 8 mg/kg | Change From Baseline to Weeks 12 and 24 in Number of Days as Assessed by SF-HLQ | Missed working days, Week 24 (n=25) | -3.3 days | Standard Deviation 5.1 |
| Tocilizumab 8 mg/kg | Change From Baseline to Weeks 12 and 24 in Number of Days as Assessed by SF-HLQ | Days with reduced capacity, Week 24 (n=19) | -6.1 days | Standard Deviation 10.7 |
Secondary
Change From Baseline to Weeks 12 and 24 in Number of Hours as Assessed by SF-HLQ
Number of working hours lost, and number of hours of support in in taking over and performing usual household tasks in the last month: chores done by family members, chores done by other persons receiving no pay, home care, other paid care, total number of unpaid hours, and total number of hours during the last month were reported. Changes from baseline were only calculated in participants who completed the questionnaire at all times (baseline, Week 12, and Week 24). Negative number indicates improvement.
Time frame: Baseline
Population: ITT population; n=number of participants assessed for the specified parameter.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab 8 mg/kg | Change From Baseline to Weeks 12 and 24 in Number of Hours as Assessed by SF-HLQ | Work lost, Week 12 (n=17) | -8.9 hours | Standard Deviation 15.2 |
| Tocilizumab 8 mg/kg | Change From Baseline to Weeks 12 and 24 in Number of Hours as Assessed by SF-HLQ | Work lost, Week 24 (n=17) | -12.1 hours | Standard Deviation 20.3 |
| Tocilizumab 8 mg/kg | Change From Baseline to Weeks 12 and 24 in Number of Hours as Assessed by SF-HLQ | Chores by family, Week 12 (n=77) | -4.4 hours | Standard Deviation 27.4 |
| Tocilizumab 8 mg/kg | Change From Baseline to Weeks 12 and 24 in Number of Hours as Assessed by SF-HLQ | Chores by family, Week 24 (n=77) | -3.2 hours | Standard Deviation 32 |
| Tocilizumab 8 mg/kg | Change From Baseline to Weeks 12 and 24 in Number of Hours as Assessed by SF-HLQ | Chores by other unpaid person, Week 12 (n=77) | -0.1 hours | Standard Deviation 0.8 |
| Tocilizumab 8 mg/kg | Change From Baseline to Weeks 12 and 24 in Number of Hours as Assessed by SF-HLQ | Chores by other unpaid person, Week 24 (n=77) | -0.2 hours | Standard Deviation 0.8 |
| Tocilizumab 8 mg/kg | Change From Baseline to Weeks 12 and 24 in Number of Hours as Assessed by SF-HLQ | Other paid care, Week 12 (n=77) | 1.8 hours | Standard Deviation 15.5 |
| Tocilizumab 8 mg/kg | Change From Baseline to Weeks 12 and 24 in Number of Hours as Assessed by SF-HLQ | Other paid care, Week 24 (n=77) | -0.1 hours | Standard Deviation 5.1 |
| Tocilizumab 8 mg/kg | Change From Baseline to Weeks 12 and 24 in Number of Hours as Assessed by SF-HLQ | Total unpaid, Week 12 (n=77) | -4.5 hours | Standard Deviation 27.3 |
| Tocilizumab 8 mg/kg | Change From Baseline to Weeks 12 and 24 in Number of Hours as Assessed by SF-HLQ | Total unpaid, Week 24 (n=77) | -3.6 hours | Standard Deviation 32 |
| Tocilizumab 8 mg/kg | Change From Baseline to Weeks 12 and 24 in Number of Hours as Assessed by SF-HLQ | Total, Week 12 (n=77) | -2.7 hours | Standard Deviation 31.7 |
| Tocilizumab 8 mg/kg | Change From Baseline to Weeks 12 and 24 in Number of Hours as Assessed by SF-HLQ | Total, Week 24 (n=77) | -3.7 hours | Standard Deviation 32.4 |
Secondary
Change From Baseline to Weeks 12 and 24 SF-HLQ Hindrance Score
Participants were asked if health problems hindered their paid work on a scale of 1 to 3 (1=no, 2=yes, slightly, 3=yes, very much) and their unpaid work including household work, going shopping, odd jobs, specific activities sharing the household on a scale of 0 to 3 (0=performed without being bothered by healthy problems; 1=performed although bothered by health problems; 2=not performed because of health problems; 3=not performed for reasons other than health problems). Hindrance score is a measure of the hindrance experienced as a result of health problems during the performance of unpaid work. The minimum score per item for hindrance score was 0, maximum score was 2 (Score of 3 was not considered since the reasons were other than health problems). Total score was calculated by adding all 4 items together and ranged from 0 (best possible score) to 8 (worst possible score). A negative change from baseline indicates improvement.
Time frame: Baseline
Population: ITT population; n=number of participants assessed for the specified parameter.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab 8 mg/kg | Change From Baseline to Weeks 12 and 24 SF-HLQ Hindrance Score | Paid work, Week 12 (n=23) | -0.30 units on a scale | Standard Deviation 0.7 |
| Tocilizumab 8 mg/kg | Change From Baseline to Weeks 12 and 24 SF-HLQ Hindrance Score | Paid work, Week 24 (n=23) | -0.39 units on a scale | Standard Deviation 0.58 |
| Tocilizumab 8 mg/kg | Change From Baseline to Weeks 12 and 24 SF-HLQ Hindrance Score | Household work, Week 12 (n=84) | -0.40 units on a scale | Standard Deviation 0.7 |
| Tocilizumab 8 mg/kg | Change From Baseline to Weeks 12 and 24 SF-HLQ Hindrance Score | Household work, Week 24 (n=84) | -0.40 units on a scale | Standard Deviation 0.68 |
| Tocilizumab 8 mg/kg | Change From Baseline to Weeks 12 and 24 SF-HLQ Hindrance Score | Going shopping, Week 12 (n=84) | -0.40 units on a scale | Standard Deviation 0.64 |
| Tocilizumab 8 mg/kg | Change From Baseline to Weeks 12 and 24 SF-HLQ Hindrance Score | Going shopping, Week 24 (n=84) | -0.40 units on a scale | Standard Deviation 0.62 |
| Tocilizumab 8 mg/kg | Change From Baseline to Weeks 12 and 24 SF-HLQ Hindrance Score | Odd jobs, Week 12 (n=84) | -0.38 units on a scale | Standard Deviation 0.79 |
| Tocilizumab 8 mg/kg | Change From Baseline to Weeks 12 and 24 SF-HLQ Hindrance Score | Odd jobs, Week 24 (n=84) | -0.36 units on a scale | Standard Deviation 0.83 |
| Tocilizumab 8 mg/kg | Change From Baseline to Weeks 12 and 24 SF-HLQ Hindrance Score | Activities for/with children, Week 12 (n=85) | -0.16 units on a scale | Standard Deviation 0.69 |
| Tocilizumab 8 mg/kg | Change From Baseline to Weeks 12 and 24 SF-HLQ Hindrance Score | Activities for/with children, Week 24 (n=85) | -0.24 units on a scale | Standard Deviation 0.7 |
| Tocilizumab 8 mg/kg | Change From Baseline to Weeks 12 and 24 SF-HLQ Hindrance Score | Total score, Week 12 (n=84) | -1.33 units on a scale | Standard Deviation 2.19 |
| Tocilizumab 8 mg/kg | Change From Baseline to Weeks 12 and 24 SF-HLQ Hindrance Score | Total score, Week 24 (n=84) | -1.38 units on a scale | Standard Deviation 2.18 |
Secondary
Efficiency as Assessed by SF-HLQ
Participants were ask to rate their efficiency in working on a scale of of 0 to 10 (0=very worse, 10=as usual). Overall efficiency score was based on the first 6 items of Question 6, which is a descriptive instrument comprised of 7 items designed to evaluate the specific problems affecting production. These 7 items relate to the effect of health problems on concentration, work pace, the need to be alone, making decisions, postponing and transferring work to others. The participant can choose from 4 possible answers: (almost) never, sometimes, often and (nearly) always. Efficiency score range=6 to 24; higher scores indicate higher impairment.
Time frame: Baseline
Population: ITT population; n=number of participants assessed for the specified parameter.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab 8 mg/kg | Efficiency as Assessed by SF-HLQ | Efficiency in working (n=21) | 6.3 units on a scale | Standard Deviation 2.4 |
| Tocilizumab 8 mg/kg | Efficiency as Assessed by SF-HLQ | Efficiency score (n=24) | 10.1 units on a scale | Standard Deviation 3.2 |
Secondary
FACIT-F Scores
The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants 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). Clinically relevant improvement is defined as a ≥5-point change from Baseline.
Time frame: Baseline, Weeks 2, 4, 8,12, 16, 20 and 24
Population: ITT population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab 8 mg/kg | FACIT-F Scores | Baseline (n=105) | 28.60 units on a scale | Standard Deviation 9.77 |
| Tocilizumab 8 mg/kg | FACIT-F Scores | Week 2 (n=102) | 35.54 units on a scale | Standard Deviation 8.53 |
| Tocilizumab 8 mg/kg | FACIT-F Scores | Week 4 (n=101) | 37.24 units on a scale | Standard Deviation 8.46 |
| Tocilizumab 8 mg/kg | FACIT-F Scores | Week 8 (n=102) | 39.16 units on a scale | Standard Deviation 7.35 |
| Tocilizumab 8 mg/kg | FACIT-F Scores | Week 12 n=94 | 39.02 units on a scale | Standard Deviation 8.01 |
| Tocilizumab 8 mg/kg | FACIT-F Scores | Week 16 (n=97) | 40.21 units on a scale | Standard Deviation 7.87 |
| Tocilizumab 8 mg/kg | FACIT-F Scores | Week 20 (n=91) | 40.05 units on a scale | Standard Deviation 7.77 |
| Tocilizumab 8 mg/kg | FACIT-F Scores | Week 24/End of Study (n=102) | 39.69 units on a scale | Standard Deviation 8.39 |
Secondary
Improvement of Anemia Assessed as Change From Baseline in Hemoglobin
Improvement of anemia was evaluated as change in hemoglobin levels from baseline.
Time frame: Weeks 2, 4, 8, 12, 16, 20, and 24
Population: ITT population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab 8 mg/kg | Improvement of Anemia Assessed as Change From Baseline in Hemoglobin | Week 20 (n=90) | 0.67 g/dL | Standard Deviation 1.1 |
| Tocilizumab 8 mg/kg | Improvement of Anemia Assessed as Change From Baseline in Hemoglobin | Week 2 (n=99) | 0.47 g/dL | Standard Deviation 0.69 |
| Tocilizumab 8 mg/kg | Improvement of Anemia Assessed as Change From Baseline in Hemoglobin | Week 4 (n=101) | 0.40 g/dL | Standard Deviation 0.78 |
| Tocilizumab 8 mg/kg | Improvement of Anemia Assessed as Change From Baseline in Hemoglobin | Week 8 (n=100) | 0.56 g/dL | Standard Deviation 0.95 |
| Tocilizumab 8 mg/kg | Improvement of Anemia Assessed as Change From Baseline in Hemoglobin | Week 12 (n=94) | 0.64 g/dL | Standard Deviation 1.04 |
| Tocilizumab 8 mg/kg | Improvement of Anemia Assessed as Change From Baseline in Hemoglobin | Week 16 (n=95) | 0.62 g/dL | Standard Deviation 1.08 |
| Tocilizumab 8 mg/kg | Improvement of Anemia Assessed as Change From Baseline in Hemoglobin | Week 24/End of Study (n=100) | 0.64 g/dL | Standard Deviation 1.2 |
Secondary
Improvement of Fatigue Assessed as Change From Baseline in FACIT-F Scores
The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants 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). Clinically relevant improvement is defined as a ≥5-point change from Baseline.
Time frame: Weeks 2, 4, 8, 12, 16, 20 and 24
Population: ITT population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab 8 mg/kg | Improvement of Fatigue Assessed as Change From Baseline in FACIT-F Scores | Week 2 (n=102) | 7.11 units on a scale | Standard Deviation 8.4 |
| Tocilizumab 8 mg/kg | Improvement of Fatigue Assessed as Change From Baseline in FACIT-F Scores | Week 4 (n=101) | 8.76 units on a scale | Standard Deviation 8.83 |
| Tocilizumab 8 mg/kg | Improvement of Fatigue Assessed as Change From Baseline in FACIT-F Scores | Week 8 (n=102) | 10.74 units on a scale | Standard Deviation 9.49 |
| Tocilizumab 8 mg/kg | Improvement of Fatigue Assessed as Change From Baseline in FACIT-F Scores | Week 12 (n=94) | 10.60 units on a scale | Standard Deviation 10.13 |
| Tocilizumab 8 mg/kg | Improvement of Fatigue Assessed as Change From Baseline in FACIT-F Scores | Week 16 (n=97) | 11.47 units on a scale | Standard Deviation 10.24 |
| Tocilizumab 8 mg/kg | Improvement of Fatigue Assessed as Change From Baseline in FACIT-F Scores | Week 20 (n=91) | 11.63 units on a scale | Standard Deviation 10.22 |
| Tocilizumab 8 mg/kg | Improvement of Fatigue Assessed as Change From Baseline in FACIT-F Scores | Week 24/End of Study (n=102) | 10.84 units on a scale | Standard Deviation 11 |
Secondary
Mean Hemoglobin Levels During the Study
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24
Population: ITT population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab 8 mg/kg | Mean Hemoglobin Levels During the Study | Baseline (n=105) | 12.41 g/dL | Standard Deviation 1.51 |
| Tocilizumab 8 mg/kg | Mean Hemoglobin Levels During the Study | Week 2 (n=99) | 12.84 g/dL | Standard Deviation 1.47 |
| Tocilizumab 8 mg/kg | Mean Hemoglobin Levels During the Study | Week 4 (n=101) | 12.79 g/dL | Standard Deviation 1.44 |
| Tocilizumab 8 mg/kg | Mean Hemoglobin Levels During the Study | Week 8 (n=100) | 12.95 g/dL | Standard Deviation 1.45 |
| Tocilizumab 8 mg/kg | Mean Hemoglobin Levels During the Study | Week 12 (n=94) | 13.06 g/dL | Standard Deviation 1.49 |
| Tocilizumab 8 mg/kg | Mean Hemoglobin Levels During the Study | Week 16 (n=95) | 13.10 g/dL | Standard Deviation 1.42 |
| Tocilizumab 8 mg/kg | Mean Hemoglobin Levels During the Study | Week 20 (n=90) | 13.13 g/dL | Standard Deviation 1.4 |
| Tocilizumab 8 mg/kg | Mean Hemoglobin Levels During the Study | Week 24/End of Study (n=100) | 13.12 g/dL | Standard Deviation 1.39 |
Secondary
Number of Days as Assessed by Short Form-Health and Labour Questionnaire (SF-HLQ)
The SF-HLQ assessed productivity losses related to health problems in individuals with paid or unpaid work and consists of three modules (absenteeism from paid work, production losses without absenteeism from paid work and hindrance in the performance of paid and unpaid work). Any missed working days or number of worked days with reduced efficiency during the last month were reported.
Time frame: Baseline
Population: ITT population; n=number of participants assessed for the specified parameter.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab 8 mg/kg | Number of Days as Assessed by Short Form-Health and Labour Questionnaire (SF-HLQ) | Missed working days (n=25) | 3.6 days | Standard Deviation 5 |
| Tocilizumab 8 mg/kg | Number of Days as Assessed by Short Form-Health and Labour Questionnaire (SF-HLQ) | Days with reduced capacity (n=19) | 11.8 days | Standard Deviation 8.8 |
Secondary
Number of Hours as Assessed by SF-HLQ
Number of working hours lost, and number of hours of support in in taking over and performing usual household tasks in the last month: chores done by family members, chores done by other persons receiving no pay, home care, other paid care, total number of unpaid hours, and total number of hours during the last month were reported.
Time frame: Baseline
Population: ITT population; n=number of participants assessed for the specified parameter.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab 8 mg/kg | Number of Hours as Assessed by SF-HLQ | Other paid care (n=77) | 1.1 hours | Standard Deviation 4.2 |
| Tocilizumab 8 mg/kg | Number of Hours as Assessed by SF-HLQ | Work lost (n=17) | 13.6 hours | Standard Deviation 19.8 |
| Tocilizumab 8 mg/kg | Number of Hours as Assessed by SF-HLQ | Chores by family (n=77) | 10.3 hours | Standard Deviation 26.5 |
| Tocilizumab 8 mg/kg | Number of Hours as Assessed by SF-HLQ | Chores by other unpaid person (n=77) | 0.2 hours | Standard Deviation 0.8 |
| Tocilizumab 8 mg/kg | Number of Hours as Assessed by SF-HLQ | Home care (n=77) | 0.0 hours | Standard Deviation 0 |
| Tocilizumab 8 mg/kg | Number of Hours as Assessed by SF-HLQ | Total unpaid (n=77) | 10.4 hours | Standard Deviation 26.5 |
| Tocilizumab 8 mg/kg | Number of Hours as Assessed by SF-HLQ | Total (n=77) | 11.5 hours | Standard Deviation 26.4 |
Secondary
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50% or 70% Improvement
The ACR response rates ACR20, ACR50, and ACR70 were defined as ≥20%, ≥50% and ≥ 70% improvement, respectively, in: swollen joint count (SJC) (66 joints) and tender joint count (TJC) (68 joints) and 3 of the 5 remaining ACR parameters: Patient assessment of pain; Patient Global Assessment of Disease Activity; Investigator Global Assessment of Disease Activity; participant self-rated assessment of disability measured by the Health Assessment Questionnaire Disability Index (HAQ-DI); and acute phase response (erythrocyte sedimentation rate \[ESR\] or C-reactive protein \[CRP\]).
Time frame: Week 24
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab 8 mg/kg | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50% or 70% Improvement | ACR20 | 81.0 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50% or 70% Improvement | ACR50 | 59.0 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50% or 70% Improvement | ACR70 | 42.9 percentage of participants |
Secondary
Percentage of Participants With an Improvement of ≥1 g/dL in Hemoglobin
Time frame: Week 24
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tocilizumab 8 mg/kg | Percentage of Participants With an Improvement of ≥1 g/dL in Hemoglobin | 31.4 percentage of participants |
Secondary
Percentage of Participants With a Response at Week 24 by DAS28 Category
DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the ESR (mm/hr) and patient's global assessment of disease activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2=low disease activity, DAS28 \>5.1=high disease activity and DAS \<2.6=remission.
Time frame: Week 24
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab 8 mg/kg | Percentage of Participants With a Response at Week 24 by DAS28 Category | DAS28 <2.6 | 49.5 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With a Response at Week 24 by DAS28 Category | DAS28 ≥2.6 | 50.5 percentage of participants |
Secondary
Percentage of Participants With a Response at Week 24 by European League Against Rheumatism (EULAR) Category
Disease response was assessed using EULAR Disease Activity Score Based on 28-Joint Count (DAS28) categories of Good, Moderate, or No Response. Good response was defined as a DAS28 score of less than (\<)3.2 and improvement from baseline of \>1.2; Moderate response was defined as a DAS28 score of 3.2-5.1 and improvement from baseline of 1.2-0.6 or a DAS28 score of \>5.1 and improvement from baseline of \>1.2; No response was defined as a DAS28 score of \>5.1 and improvement from baseline of \<1.2. Participants who discontinued prematurely were identified as non-responders.
Time frame: Week 24
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tocilizumab 8 mg/kg | Percentage of Participants With a Response at Week 24 by European League Against Rheumatism (EULAR) Category | No Response | 12.4 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With a Response at Week 24 by European League Against Rheumatism (EULAR) Category | Moderate Response | 23.8 percentage of participants |
| Tocilizumab 8 mg/kg | Percentage of Participants With a Response at Week 24 by European League Against Rheumatism (EULAR) Category | Good Response | 63.8 percentage of participants |
Secondary
Percent Change From Baseline to Week 24 in DAS28 Score
DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the ESR (mm/hr) and patient's global assessment of disease activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2=low disease activity, DAS28 \>5.1=high disease activity and DAS \<2.6=remission.
Time frame: Week 24
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tocilizumab 8 mg/kg | Percent Change From Baseline to Week 24 in DAS28 Score | -55.78 percent change from baseline | Standard Deviation 23.49 |
Secondary
Percent Change From Baseline to Week 24 in ESR
ESR is a blood test used to monitor therapy in inflammatory diseases such as RA and reflects acute phase reactant levels. ESR is measured in mm per hour (mm/hr); active disease in RA is defined by an ESR greater than 30 mm/hr.
Time frame: Week 24
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tocilizumab 8 mg/kg | Percent Change From Baseline to Week 24 in ESR | -66.00 percent change in mm/hr | Standard Deviation 47.73 |
Secondary
Percent Change From Baseline to Week 24 in HAQ-DI
HAQ-DI includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Overall score was computed as the sum of the domain scores and divided by the number of domains answered. Total possible score range was 0-3 where 0 (equals)=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all.
Time frame: Week 24
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tocilizumab 8 mg/kg | Percent Change From Baseline to Week 24 in HAQ-DI | -45.94 percent change from baseline | Standard Deviation 54.17 |
Secondary
Percent Change From Baseline to Week 24 in High-Sensitivity CRP (Hs-CRP)
hs-CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). hsCRP is measured in milligrams per liter (mg/L).
Time frame: Week 24
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tocilizumab 8 mg/kg | Percent Change From Baseline to Week 24 in High-Sensitivity CRP (Hs-CRP) | -53.33 percent change in mg/L | Standard Deviation 149.9 |
Secondary
Percent Change From Baseline to Week 24 in Investigator's Global Assessment of Disease Activity
The physician's assessment of the participant's current disease activity was displayed on a 100-mm horizontal VAS. The left-hand extreme of the line was described as no disease activity (symptom-free and no arthritis symptoms) and the right-hand extreme was considered maximum disease activity. The physician's global assessment of disease activity was completed by the Efficacy Assessor who could or could not be a physician. The assessor was asked to mark the line corresponding to their assessment of the participant's present level of disease activity; the distance from the left edge was recorded.
Time frame: Week 24
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tocilizumab 8 mg/kg | Percent Change From Baseline to Week 24 in Investigator's Global Assessment of Disease Activity | -65.89 percent change in mm | Standard Deviation 36.72 |
Secondary
Percent Change From Baseline to Week 24 in Patient Global Assessment of Pain
The participant's assessment of their current level of pain was displayed on a 100-millimeter (mm) horizontal visual analog scale (VAS). The left-hand extreme of the line was described as no pain and the right-hand as unbearable pain. The participant was asked to mark the line that corresponded to their current level of pain; the distance from the left edge was recorded.
Time frame: Week 24
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tocilizumab 8 mg/kg | Percent Change From Baseline to Week 24 in Patient Global Assessment of Pain | -52.25 percent change in mm | Standard Deviation 56.88 |
Secondary
Percent Change From Baseline to Week 24 in Patient's Global Assessment of Disease Activity
The participant's overall assessment of their current disease activity was displayed on a 100-mm horizontal VAS. The left-hand extreme of the line was described as no disease activity (symptom free and no arthritis symptoms) and the right-hand extreme as maximum disease activity (maximum arthritis disease activity). Participants were asked to assess their current level of disease activity and mark the line; the distance from the left edge was recorded.
Time frame: Week 24
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tocilizumab 8 mg/kg | Percent Change From Baseline to Week 24 in Patient's Global Assessment of Disease Activity | -55.43 percent change in mm | Standard Deviation 56.12 |
Secondary
Percent Change From Baseline to Week 24 in SJC
Sixty-six (66) joints were assessed at each visit for swelling; joints were assessed and classified as swollen/not swollen. Swollen joint count 66 (SJC-66) was calculated as the number of swollen joints from 66 joints; the number of swollen joints was summed (maximum score 66). Calculated values were used for the analysis. A negative score indicated improvement.
Time frame: Week 24
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tocilizumab 8 mg/kg | Percent Change From Baseline to Week 24 in SJC | -77.59 percent change in swollen joints | Standard Deviation 31.22 |
Secondary
Percent Change From Baseline to Week 24 in TJC
Sixty-eight (68) joints were assessed at each visit for tenderness; joints were assessed and classified as tender/not tender. Tender joint count 68 (TJC-68) was calculated as the number of tender joints from 68 joints; the number of tender joints was summed (maximum score 68). Calculated values were used for the analysis. A negative score indicated improvement.
Time frame: Week 24
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tocilizumab 8 mg/kg | Percent Change From Baseline to Week 24 in TJC | -70.65 percent change in tender joints | Standard Deviation 47.71 |
Secondary
SF-HLQ Hindrance Score
Participants were asked if their health problems hindered their paid work on a scale of 1 to 3 (1=no, 2=yes, slightly, 3=yes, very much) and their unpaid work including household work, going shopping, odd jobs, specific activities sharing the household on a scale of 0 to 3 (0=performed without being bothered by healthy problems; 1=performed although bothered by health problems; 2=not performed because of health problems; 3=not performed for reasons other than health problems). The total hindrance score for unpaid work was derived by adding up the item scores. This hindrance score is a measure of the hindrance experienced as a result of health problems during the performance of unpaid work. The minimum score per item for hindrance score was 0, maximum score was 2 (Score of 3 was not considered since the reasons were other than health problems). Total score was calculated by adding all 4 items together and ranged from 0 (best possible score) to 8 (worst possible score).
Time frame: Baseline
Population: ITT population; n=number of participants assessed for the specified parameter.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab 8 mg/kg | SF-HLQ Hindrance Score | Paid work (n=23) | 0.9 units on a scale | Standard Deviation 0.5 |
| Tocilizumab 8 mg/kg | SF-HLQ Hindrance Score | Household work (n=84) | 1.1 units on a scale | Standard Deviation 0.5 |
| Tocilizumab 8 mg/kg | SF-HLQ Hindrance Score | Going shopping (n=84) | 1.0 units on a scale | Standard Deviation 0.6 |
| Tocilizumab 8 mg/kg | SF-HLQ Hindrance Score | Odd jobs (n=84) | 1.1 units on a scale | Standard Deviation 0.7 |
| Tocilizumab 8 mg/kg | SF-HLQ Hindrance Score | Activities for/with children (n=85) | 0.6 units on a scale | Standard Deviation 0.6 |
| Tocilizumab 8 mg/kg | SF-HLQ Hindrance Score | Total score (n=84) | 3.7 units on a scale | Standard Deviation 1.7 |