Rheumatoid Arthritis
Conditions
Brief summary
This open-label, single-arm, non-randomized study will evaluate the adherence and persistence to tocilizumab therapy in patients with moderate to severe active rheumatoid arthritis, who have an inadequate clinical response to non-biologic DMARDs. Patients will receive tocilizumab 8 mg/kg as intravenous infusion once every 4 weeks in combination with methotrexate or in case of intolerance to methotrexate as monotherapy. The anticipated time of study treatment is 6 months. The target sample size is 20-50 patients.
Interventions
DRUGtocilizumab [RoActemra/Actemra]
tocilizumab 8 mg/kg intravenous infusion once in 4 weeks
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
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 * moderate to severe active rheumatoid arthritis * inadequate response, or intolerance to previous therapy with one or more traditional DMARDs * DAS \>3.6 * pneumology examination (including chest x-ray and quantiferon)
Exclusion criteria
* \< 18 years of age * active infection * active tuberculosis * uncontrolled hyperlipoproteinaemia * demyelinating disorders * concomitant anti-TNF drugs * history of intestinal ulceration and diverticulitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Adherent to Original Treatment | Week 24 | Adherence rate to original treatment according to the protocol included all participants that received the study drug beginning from Week 8 and remaining until the end of the study. This number represents participants with no changes in treatment protocol, participants with treatment discontinuation, and participants with dose reduction, but not participants that withdrew from the study prematurely. |
| Percentage of Participants Receiving Less Than or Equal to (≤) 1 Dose of Study Drug Who Discontinued Treatment for Any Reason | Weeks 0, 4, 8, 12, 16, 20, and 24 | — |
| Percentage of Participants Receiving Greater Than (>) 1 Dose Who Discontinued Treatment for Any Reason | Weeks 0, 4, 8, 12, 16, 20, and 24 | — |
| Percentage of Participants Withdrawing From the Study Prematurely for Any Reason | Weeks 0, 4, 8, 12, 16, 20, and 24 | — |
| Percentage of Participants With Dose Reduction to Tocilizumab 4 mg/kg | Weeks 0, 4, 8, 12, 16, and 20 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tender Joint Count (TJC) | Weeks 0, 4, 8, 12, 16, 20, and 24 | The following 28 joints were assessed by the physician for tenderness: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). Joints were rated as 0=not tender or 1=tender. The total number was calculated from all the joints for a maximum score of 28. |
| Erythrocyte Sedimentation Rate (ESR) | Weeks 0, 4, 12, 20, and 24 | ESR indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation. |
| Disease Activity Score Based on 28-Joint Count (DAS28) | Weeks 0, 4, 12, and 24 | DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hr\]) 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 equals (=) low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity. |
| Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Weeks 0, 4, 8, 12, 16, 20, and 24 | The HAQ-DI was used to assess the physical ability and functional status of participants as well as quality of life. The disability dimension consists of 20 multiple choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from 4 response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. |
| Short Form-36 (SF-36) | Weeks 0, 12, and 24 | The SF-36 measures the impact of disease on overall quality of life and consists of 8 subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. Scores for each subscale range from 0 to 10, and the composite scores range from 0 to 100, with higher scores indicating better health. |
| C-Reactive Protein (CRP) | Weeks 0, 4, 12, 20, and 24 | CRP is an acute phase protein. Levels of CRP increase with inflammation. |
| Patient Global Assessment of Pain | Weeks 0, 4, 8, 12, 16, 20, and 24 | Participants were asked to rate their pain using a 0 to 100 mm visual analog scale (VAS), where 0 mm = no pain and 100 mm = worst possible pain. The participant was asked to mark the line corresponding to their perceived level of pain and the distance in mm from the left edge of the scale was measured. |
| Patient Global Assessment of Disease Activity | Weeks 0, 4, 8, 12, 16, 20, and 24 | The participant's assessment of disease activity was performed using a 100 mm VAS ranging from no activity (0) to maximal activity (100). The participant was asked to mark the line corresponding to their perceived level of disease activity and the distance in mm from the left edge of the scale was measured. |
| Physician's Global Assessment of Disease Activity | Weeks 0, 4, 8, 12, 16, 20, and 24 | Physician's global assessment of disease activity was performed using a 100 mm VAS ranging from no arthritis activity (0) to maximal arthritis activity (100). The physician was asked to mark the line corresponding to their perceived level of the participant's disease activity and the distance in mm from the left edge of the scale was measured. |
| Swollen Joint Count (SJC) | Weeks 0, 4, 8, 12, 16, 20, and 24 | The following 28 joints were assessed by the physician for swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). Joints were rated as 0=not swollen or 1=swollen. The total number was calculated from all the joints for a maximum score of 28. |
Countries
Slovakia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tocilizumab 8 mg/kg Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). | 32 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Death | 1 |
Baseline characteristics
| Characteristic | Tocilizumab 8 mg/kg |
|---|---|
| Age, Continuous | 52.38 years STANDARD_DEVIATION 12.05 |
| C-Reactive Protein (CRP) | 17.84 mg/L STANDARD_DEVIATION 21.3 |
| Disease Duration | 11.97 years STANDARD_DEVIATION 10.55 |
| Disease Phase/Stage Phase/Stage I | 4 participants |
| Disease Phase/Stage Phase/Stage II | 12 participants |
| Disease Phase/Stage Phase/Stage III | 12 participants |
| Disease Phase/Stage Phase/Stage IV | 4 participants |
| Erythrocyte Sedimentation Rate (ESR) | 55.81 mm/hr STANDARD_DEVIATION 25.05 |
| Functional Class of Disease Class I | 0 participants |
| Functional Class of Disease Class II | 10 participants |
| Functional Class of Disease Class III | 22 participants |
| Functional Class of Disease Class IV | 0 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 32 Participants |
| Region of Enrollment Slovakia | 32 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 10 / 32 |
| serious Total, serious adverse events | 3 / 32 |
Outcome results
Primary
Percentage of Participants Adherent to Original Treatment
Adherence rate to original treatment according to the protocol included all participants that received the study drug beginning from Week 8 and remaining until the end of the study. This number represents participants with no changes in treatment protocol, participants with treatment discontinuation, and participants with dose reduction, but not participants that withdrew from the study prematurely.
Time frame: Week 24
Population: Intent-to-treat population (ITT), all enrolled participants who received at least one dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tocilizumab 8 mg/kg | Percentage of Participants Adherent to Original Treatment | 93.75 percentage of participants |
Primary
Percentage of Participants Receiving Greater Than (>) 1 Dose Who Discontinued Treatment for Any Reason
Time frame: Weeks 0, 4, 8, 12, 16, 20, and 24
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tocilizumab 8 mg/kg | Percentage of Participants Receiving Greater Than (>) 1 Dose Who Discontinued Treatment for Any Reason | 0 percentage of participants |
Primary
Percentage of Participants Receiving Less Than or Equal to (≤) 1 Dose of Study Drug Who Discontinued Treatment for Any Reason
Time frame: Weeks 0, 4, 8, 12, 16, 20, and 24
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tocilizumab 8 mg/kg | Percentage of Participants Receiving Less Than or Equal to (≤) 1 Dose of Study Drug Who Discontinued Treatment for Any Reason | 3.13 percentage of participants |
Primary
Percentage of Participants With Dose Reduction to Tocilizumab 4 mg/kg
Time frame: Weeks 0, 4, 8, 12, 16, and 20
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tocilizumab 8 mg/kg | Percentage of Participants With Dose Reduction to Tocilizumab 4 mg/kg | 18.75 percentage of participants |
Primary
Percentage of Participants Withdrawing From the Study Prematurely for Any Reason
Time frame: Weeks 0, 4, 8, 12, 16, 20, and 24
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tocilizumab 8 mg/kg | Percentage of Participants Withdrawing From the Study Prematurely for Any Reason | 6.25 percentage of participants |
Secondary
C-Reactive Protein (CRP)
CRP is an acute phase protein. Levels of CRP increase with inflammation.
Time frame: Weeks 0, 4, 12, 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 | C-Reactive Protein (CRP) | Week 0 (n=32) | 17.84 mg/L | Standard Deviation 21.3 |
| Tocilizumab 8 mg/kg | C-Reactive Protein (CRP) | Week 4 (n=32) | 5.03 mg/L | Standard Deviation 6.07 |
| Tocilizumab 8 mg/kg | C-Reactive Protein (CRP) | Week 12 (n=30) | 5.54 mg/L | Standard Deviation 9.22 |
| Tocilizumab 8 mg/kg | C-Reactive Protein (CRP) | Week 20 (n=30) | 6.71 mg/L | Standard Deviation 13.9 |
| Tocilizumab 8 mg/kg | C-Reactive Protein (CRP) | Week 24 (n=30) | 2.97 mg/L | Standard Deviation 0.7 |
Secondary
Disease Activity Score Based on 28-Joint Count (DAS28)
DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hr\]) 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 equals (=) low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.
Time frame: Weeks 0, 4, 12, 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 | Disease Activity Score Based on 28-Joint Count (DAS28) | Week 0 (n=32) | 7.02 units on a scale | Standard Deviation 0.66 |
| Tocilizumab 8 mg/kg | Disease Activity Score Based on 28-Joint Count (DAS28) | Week 4 (n=32) | 4.30 units on a scale | Standard Deviation 1.04 |
| Tocilizumab 8 mg/kg | Disease Activity Score Based on 28-Joint Count (DAS28) | Week 12 (n=30) | 2.85 units on a scale | Standard Deviation 1.11 |
| Tocilizumab 8 mg/kg | Disease Activity Score Based on 28-Joint Count (DAS28) | Week 24 (n=30) | 2.57 units on a scale | Standard Deviation 0.91 |
Secondary
Erythrocyte Sedimentation Rate (ESR)
ESR indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation.
Time frame: Weeks 0, 4, 12, 20, and 24
Population: TT population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tocilizumab 8 mg/kg | Erythrocyte Sedimentation Rate (ESR) | Week 0 (n=32) | 55.81 mm/hr | Standard Deviation 25.05 |
| Tocilizumab 8 mg/kg | Erythrocyte Sedimentation Rate (ESR) | Week 4 (n=32) | 16.69 mm/hr | Standard Deviation 10.88 |
| Tocilizumab 8 mg/kg | Erythrocyte Sedimentation Rate (ESR) | Week 12 (n=30) | 15.23 mm/hr | Standard Deviation 14.78 |
| Tocilizumab 8 mg/kg | Erythrocyte Sedimentation Rate (ESR) | Week 20 (n=30) | 14.17 mm/hr | Standard Deviation 17.81 |
| Tocilizumab 8 mg/kg | Erythrocyte Sedimentation Rate (ESR) | Week 24 (n=30) | 11.00 mm/hr | Standard Deviation 7.94 |
Secondary
Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
The HAQ-DI was used to assess the physical ability and functional status of participants as well as quality of life. The disability dimension consists of 20 multiple choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from 4 response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.
Time frame: Weeks 0, 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 | Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Week 0 (n=32) | 1.77 scores on a scale | Standard Deviation 0.43 |
| Tocilizumab 8 mg/kg | Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Week 4 (n=32) | 1.56 scores on a scale | Standard Deviation 0.49 |
| Tocilizumab 8 mg/kg | Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Week 8 (n=30) | 1.31 scores on a scale | Standard Deviation 0.65 |
| Tocilizumab 8 mg/kg | Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Week 12 (n=30) | 1.28 scores on a scale | Standard Deviation 0.65 |
| Tocilizumab 8 mg/kg | Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Week 16 (n=30) | 1.23 scores on a scale | Standard Deviation 0.64 |
| Tocilizumab 8 mg/kg | Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Week 20 (n=30) | 1.20 scores on a scale | Standard Deviation 0.644 |
| Tocilizumab 8 mg/kg | Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Week 24 (n=30) | 1.16 scores on a scale | Standard Deviation 0.63 |
Secondary
Patient Global Assessment of Disease Activity
The participant's assessment of disease activity was performed using a 100 mm VAS ranging from no activity (0) to maximal activity (100). The participant was asked to mark the line corresponding to their perceived level of disease activity and the distance in mm from the left edge of the scale was measured.
Time frame: Weeks 0, 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 | Patient Global Assessment of Disease Activity | Week 0 (n=32) | 61.75 units on a scale | Standard Deviation 11.76 |
| Tocilizumab 8 mg/kg | Patient Global Assessment of Disease Activity | Week 4 (n=32) | 35.59 units on a scale | Standard Deviation 16.62 |
| Tocilizumab 8 mg/kg | Patient Global Assessment of Disease Activity | Week 8 (n=30) | 22.20 units on a scale | Standard Deviation 14.86 |
| Tocilizumab 8 mg/kg | Patient Global Assessment of Disease Activity | Week 12 (n=30) | 18.20 units on a scale | Standard Deviation 14.57 |
| Tocilizumab 8 mg/kg | Patient Global Assessment of Disease Activity | Week 16 (n=30) | 18.80 units on a scale | Standard Deviation 13.42 |
| Tocilizumab 8 mg/kg | Patient Global Assessment of Disease Activity | Week 20 (n=30) | 18.13 units on a scale | Standard Deviation 18.49 |
| Tocilizumab 8 mg/kg | Patient Global Assessment of Disease Activity | Week 24 (n=30) | 15.47 units on a scale | Standard Deviation 12.62 |
Secondary
Patient Global Assessment of Pain
Participants were asked to rate their pain using a 0 to 100 mm visual analog scale (VAS), where 0 mm = no pain and 100 mm = worst possible pain. The participant was asked to mark the line corresponding to their perceived level of pain and the distance in mm from the left edge of the scale was measured.
Time frame: Weeks 0, 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 | Patient Global Assessment of Pain | Week 0 (n=32) | 59.91 units on a scale | Standard Deviation 14.66 |
| Tocilizumab 8 mg/kg | Patient Global Assessment of Pain | Week 4 (n=32) | 36.31 units on a scale | Standard Deviation 17.1 |
| Tocilizumab 8 mg/kg | Patient Global Assessment of Pain | Week 8 (n=30) | 22.3 units on a scale | Standard Deviation 15.79 |
| Tocilizumab 8 mg/kg | Patient Global Assessment of Pain | Week 12 (n=30) | 17.30 units on a scale | Standard Deviation 14 |
| Tocilizumab 8 mg/kg | Patient Global Assessment of Pain | Week 16 (n=30) | 18.93 units on a scale | Standard Deviation 14.59 |
| Tocilizumab 8 mg/kg | Patient Global Assessment of Pain | Week 20 (n=30) | 16.73 units on a scale | Standard Deviation 15.11 |
| Tocilizumab 8 mg/kg | Patient Global Assessment of Pain | Week 24 (n=30) | 14.87 units on a scale | Standard Deviation 11.32 |
Secondary
Physician's Global Assessment of Disease Activity
Physician's global assessment of disease activity was performed using a 100 mm VAS ranging from no arthritis activity (0) to maximal arthritis activity (100). The physician was asked to mark the line corresponding to their perceived level of the participant's disease activity and the distance in mm from the left edge of the scale was measured.
Time frame: Weeks 0, 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 | Physician's Global Assessment of Disease Activity | Week 0 (n=32) | 59.63 units on a scale | Standard Deviation 7.89 |
| Tocilizumab 8 mg/kg | Physician's Global Assessment of Disease Activity | Week 4 (n=32) | 27.75 units on a scale | Standard Deviation 14 |
| Tocilizumab 8 mg/kg | Physician's Global Assessment of Disease Activity | Week 8 (n=30) | 17.40 units on a scale | Standard Deviation 9.96 |
| Tocilizumab 8 mg/kg | Physician's Global Assessment of Disease Activity | Week 12 (n=30) | 14.20 units on a scale | Standard Deviation 9.93 |
| Tocilizumab 8 mg/kg | Physician's Global Assessment of Disease Activity | Week 16 (n=30) | 13.00 units on a scale | Standard Deviation 8.68 |
| Tocilizumab 8 mg/kg | Physician's Global Assessment of Disease Activity | Week 20 (n=30) | 12.77 units on a scale | Standard Deviation 10.17 |
| Tocilizumab 8 mg/kg | Physician's Global Assessment of Disease Activity | Week 24 (n=30) | 12.47 units on a scale | Standard Deviation 8.22 |
Secondary
Short Form-36 (SF-36)
The SF-36 measures the impact of disease on overall quality of life and consists of 8 subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. Scores for each subscale range from 0 to 10, and the composite scores range from 0 to 100, with higher scores indicating better health.
Time frame: Weeks 0, 12, 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 | Short Form-36 (SF-36) | Physical Functioning, Week 0 (n=32) | 26.08 scores on a scale | Standard Deviation 18.09 |
| Tocilizumab 8 mg/kg | Short Form-36 (SF-36) | Physical Functioning, Week 12 (n=30) | 44.50 scores on a scale | Standard Deviation 27.58 |
| Tocilizumab 8 mg/kg | Short Form-36 (SF-36) | Physical Functioning, Week 24 (n=30) | 47.22 scores on a scale | Standard Deviation 31.92 |
| Tocilizumab 8 mg/kg | Short Form-36 (SF-36) | Role limits due to physical health, Week 0 (n=32) | 6.25 scores on a scale | Standard Deviation 18.71 |
| Tocilizumab 8 mg/kg | Short Form-36 (SF-36) | Role limits due to physical health, Week 12 (n=30) | 49.17 scores on a scale | Standard Deviation 45.34 |
| Tocilizumab 8 mg/kg | Short Form-36 (SF-36) | Role limits due to physical health, Week 24 (n=30) | 44.44 scores on a scale | Standard Deviation 45.6 |
| Tocilizumab 8 mg/kg | Short Form-36 (SF-36) | Role limits due to emotional prob., Week 0 (n=32) | 16.67 scores on a scale | Standard Deviation 34.23 |
| Tocilizumab 8 mg/kg | Short Form-36 (SF-36) | Role limits due to emotional prob., Week 12 (n=30) | 61.11 scores on a scale | Standard Deviation 45.34 |
| Tocilizumab 8 mg/kg | Short Form-36 (SF-36) | Role limits due to emotional prob., Week 24 (n=30) | 55.56 scores on a scale | Standard Deviation 48.47 |
| Tocilizumab 8 mg/kg | Short Form-36 (SF-36) | Energy/fatigue, Week 0 (n=32) | 30.31 scores on a scale | Standard Deviation 17.93 |
| Tocilizumab 8 mg/kg | Short Form-36 (SF-36) | Energy/ fatigue, Week 12 (n=30) | 48.33 scores on a scale | Standard Deviation 26.14 |
| Tocilizumab 8 mg/kg | Short Form-36 (SF-36) | Energy/fatigue, Week 24 (n=30) | 50.00 scores on a scale | Standard Deviation 31.32 |
| Tocilizumab 8 mg/kg | Short Form-36 (SF-36) | Emotional well-being, Week 0 (n=32) | 50.00 scores on a scale | Standard Deviation 19.1 |
| Tocilizumab 8 mg/kg | Short Form-36 (SF-36) | Emotional well-being, Week 12 (n=30) | 63.70 scores on a scale | Standard Deviation 24.16 |
| Tocilizumab 8 mg/kg | Short Form-36 (SF-36) | Emotional well-being, Week 24 (n=30) | 65.33 scores on a scale | Standard Deviation 32.92 |
| Tocilizumab 8 mg/kg | Short Form-36 (SF-36) | Social functioning, Week 0 (n=32) | 39.45 scores on a scale | Standard Deviation 17.61 |
| Tocilizumab 8 mg/kg | Short Form-36 (SF-36) | Social functioning, Week 12 (n=30) | 60.83 scores on a scale | Standard Deviation 25.36 |
| Tocilizumab 8 mg/kg | Short Form-36 (SF-36) | Social functioning, Week 24 (n=30) | 62.50 scores on a scale | Standard Deviation 35.11 |
| Tocilizumab 8 mg/kg | Short Form-36 (SF-36) | Pain, Week 0 (n=32) | 28.67 scores on a scale | Standard Deviation 15.34 |
| Tocilizumab 8 mg/kg | Short Form-36 (SF-36) | Pain, Week 12 (n=30) | 55.75 scores on a scale | Standard Deviation 27.63 |
| Tocilizumab 8 mg/kg | Short Form-36 (SF-36) | Pain, Week 24 (n=30) | 56.11 scores on a scale | Standard Deviation 33.32 |
| Tocilizumab 8 mg/kg | Short Form-36 (SF-36) | General health, Week 0 (n=32) | 38.28 scores on a scale | Standard Deviation 10.82 |
| Tocilizumab 8 mg/kg | Short Form-36 (SF-36) | General health, Week 12 (n=30) | 46.83 scores on a scale | Standard Deviation 16.32 |
| Tocilizumab 8 mg/kg | Short Form-36 (SF-36) | General health, Week 24 (n=30) | 46.25 scores on a scale | Standard Deviation 23.41 |
Secondary
Swollen Joint Count (SJC)
The following 28 joints were assessed by the physician for swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). Joints were rated as 0=not swollen or 1=swollen. The total number was calculated from all the joints for a maximum score of 28.
Time frame: Weeks 0, 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 | Swollen Joint Count (SJC) | Week 0 (n=32) | 26.66 swollen joints | Standard Deviation 7.11 |
| Tocilizumab 8 mg/kg | Swollen Joint Count (SJC) | Week 4 (n=32) | 12.03 swollen joints | Standard Deviation 8.24 |
| Tocilizumab 8 mg/kg | Swollen Joint Count (SJC) | Week 8 (n=30) | 7.00 swollen joints | Standard Deviation 6.52 |
| Tocilizumab 8 mg/kg | Swollen Joint Count (SJC) | Week 12 (n=30) | 5.33 swollen joints | Standard Deviation 6.47 |
| Tocilizumab 8 mg/kg | Swollen Joint Count (SJC) | Week 16 (n=30) | 5.33 swollen joints | Standard Deviation 6.33 |
| Tocilizumab 8 mg/kg | Swollen Joint Count (SJC) | Week 20 (n=30) | 4.20 swollen joints | Standard Deviation 5.088 |
| Tocilizumab 8 mg/kg | Swollen Joint Count (SJC) | Week 24 (n=30) | 4.00 swollen joints | Standard Deviation 5.24 |
Secondary
Tender Joint Count (TJC)
The following 28 joints were assessed by the physician for tenderness: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). Joints were rated as 0=not tender or 1=tender. The total number was calculated from all the joints for a maximum score of 28.
Time frame: Weeks 0, 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 | Tender Joint Count (TJC) | Week 0 (n=32) | 16.16 tender joints | Standard Deviation 5.18 |
| Tocilizumab 8 mg/kg | Tender Joint Count (TJC) | Week 4 (n=32) | 5.53 tender joints | Standard Deviation 5.16 |
| Tocilizumab 8 mg/kg | Tender Joint Count (TJC) | Week 8 (n=30) | 1.97 tender joints | Standard Deviation 2.01 |
| Tocilizumab 8 mg/kg | Tender Joint Count (TJC) | Week 12 (n=30) | 1.30 tender joints | Standard Deviation 1.68 |
| Tocilizumab 8 mg/kg | Tender Joint Count (TJC) | Week 16 (n=30) | 1.00 tender joints | Standard Deviation 1.2 |
| Tocilizumab 8 mg/kg | Tender Joint Count (TJC) | Week 20 (n=30) | 0.83 tender joints | Standard Deviation 1.315 |
| Tocilizumab 8 mg/kg | Tender Joint Count (TJC) | Week 24 (n=30) | 0.63 tender joints | Standard Deviation 1 |