Rheumatoid Arthritis
Conditions
Brief summary
This multi-center, observational study will evaluate the treatment patterns in clinical practice, efficacy and safety of tocilizumab in participants with rheumatoid arthritis (RA) who have had an inadequate response (or were intolerant to) treatment with non-biological disease-modifying anti-rheumatic drugs (DMARDs) or with one biological agent. Data will be collected from each eligible participant initiated on tocilizumab treatment by their treating physician according to approved label for 6 months from start of treatment.
Interventions
OTHERObservational study
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
* Severe RA. * Inadequate response (or intolerant) to non-biological DMARDs or one biologic agent * Participants initiating treatment with tocilizumab on their physician's decision (in accordance with the local label), including participants who started treatment with tocilizumab within the 8 weeks prior to the enrolment visit.
Exclusion criteria
* Tocilizumab treatment more than 8 weeks prior to the enrolment visit. * Previous tocilizumab treatment in a clinical trial or for compassionate use. * Enrolled in an ongoing clinical trial and/or treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with tocilizumab. * History of autoimmune disease or any joint inflammatory disease other than RA.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation | Month 6 | Percentage of participants on tocilizumab treatment at Month 6 was calculated as: \[(participants on tocilizumab treatment at Month 6) divided by (participants evaluable for primary objective)\] multiplied by 100. |
| Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline | Baseline | Participants measured the pain intensity due to RA on a 100 millimeter (mm) VAS, where the responses were on a continuous range from 0 = no pain to 100 = unbearable pain. |
| Patient Global Assessment of Disease Activity Using VAS at Baseline | Baseline | The patient's global assessment of disease activity was measured using a 100 mm VAS, where the responses were on a continuous range from 0 = managing very well to 100 = managing very poorly. |
| Physician Global Assessment of Disease Activity Using VAS at Baseline | Baseline | Physician global assessment of disease activity was assessed on a 100 mm VAS, where 0 = no arthritis activity to 100 = extremely active arthritis. |
| Health Assessment Questionnaire Disability Index (HAQ-DI) Scores at Baseline | Baseline | The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question is evaluated according to the degree of severity on a 4-point scale. Total score for HAQ-DI is the average of all questions and ranges from 0 = without any difficulty to 3 = unable to do. |
| Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline | Baseline | TJC was determined by examining 28 and 68 joints and identifying the joints that were painful under pressure or to passive motion. Tenderness was recorded on the joint assessment form at baseline, no tenderness = 0, tenderness = 1. SJC was determined by examining 28 and 66 joints and identifying when swelling was present. Swelling was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1. |
| Erythrocyte Sedimentation Rate (ESR) at Baseline | Baseline | ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeters per hour (mm/hr). A decrease in the level indicates reduction in inflammation and therefore improvement. |
| C-Reactive Protein (CRP) at Baseline | Baseline | The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Tocilizumab Treatment | Baseline up to Month 6 | — |
| Percentage of Participants by Duration of Morning Stiffness | Baseline, Month 3, Month 6 | Duration of morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS by 1 of the six categories: less than (\<) 30 minutes, between 30 and 240 minutes, greater than (\>) 240 minutes and whole day. |
| Percentage of Participants With and Without Morning Stiffness | Baseline, Month 3, Month 6 | Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant assessed morning stiffness based on the following criteria: 1. Presence of participant's joints stiff when woke up that day, measured as yes or no 2. Duration of morning stiffness, measured using a ruler on a 100 mm VAS by 1 of the six categories: \< 30 minutes, between 30 and 240 minutes, \> 240 minutes, and the whole day. 3. Severity of morning stiffness measured using a ruler on a 100 mm VAS where the responses were on a continuous range from 0 = no stiffness to 100 = maximum stiffness. |
| Percentage of Participants Adhering to Local Label for Adverse Events | Baseline up to Month 6 | Percentage of participants who adhered to local label/protocol for the management of adverse events is reported. |
| Disease Activity Score Based on 28 Joint Count (DAS28) Score by Visit | Baseline, Month 3, Month 6 | The DAS28 score is a measurement of RA activity on a 0 to 10 scale, with higher scores representing higher disease activity, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.70 x natural logarithm (ln) (CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient global assessment of disease activity, which was measured on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly. A score of less than 2.6 represents clinical remission, a score of greater than or equal to 2.6 and less than or equal to 3.2 represents low disease activity, a score of greater than 3.2 and less than or equal to 5.1 represents moderate disease activity, and a score of greater than 5.1 represents high (or severe) disease. |
| Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6 | Month 3 and Month 6 | Clinical response was assessed according to EULAR criteria that classified the participant according to individual changes in DAS28 score as good, moderate, or no response. The DAS28 score is a measurement of RA activity on a 0 to 10 scale, with higher scores represent higher disease activity, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient's global assessment of disease activity, which was measured on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly. Good responders experienced a change from baseline of greater than 1.2 with a DAS28 score less than or equal to 3.2. |
| Clinical Disease Activity Index (CDAI) Score by Visit | Baseline, Month 3, Month 6 | The CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in centimeters) + PhGH (in centimeters), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, and PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 = no arthritis activity and 100 = extremely active arthritis; with a total score ranged from 0-76. Higher scores indicate greater disease activity. CDAI score of less than or equal to 2.8 represents clinical remission, score of less than or equal to 10.0 represents low disease activity, score of less than or equal to 22.0 represents moderate disease activity, and score of greater than 22.0 represents high (or severe) disease. |
| Change From Baseline in TJC and SJC at Month 3 and Month 6 | Baseline, Month 3, Month 6 | TJC was determined by examining 28 and 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at baseline, no tenderness = 0, tenderness = 1. SJC was determined by examination of 28 and 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1. |
| Percentage of Participants Starting Tocilizumab After Stopping a Biologic Treatment or After Failing DMARDs | Baseline | — |
| Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment | Month 3 and Month 6 | ACR 20,50 or 70 response=an improvement of ≥ 20%, ≥ 50% or ≥ 70% respectively, as compared to baseline in TJC28 and SJC28, and 20%, 50% or 70% improvement in at least 3 of the 5 following measures: Patient's Assessment of Pain over the previous 24 hours, PGA, PhGA, HAQ, and acute phase reactant (either CRP or ESR). TJC and SJC, based on 28-joint assessments. Number of tender joints and swollen joints were recorded on the joint assessment form at baseline, no tenderness = 0 and tenderness = 1, no swelling = 0 and swelling =1, respectively. HAQ measures functional status (disability) and health-related quality of life with 20 questions, summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week, 0=without difficulty to 3=unable to do. Patient's assessment of pain assessed using a VAS; 0=no pain, 100=unbearable pain; PGA and PhGA, assessed using VAS ; 0= no disease activity, 100=maximum disease activity. |
| Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6 | Baseline, Month 3, Month 6 | The physician global assessment of disease activity was evaluated using a 100 mm VAS where 0 = no arthritis activity and 100 = extremely active arthritis. Higher scores indicated increased level of disease. |
| Change From Baseline in Patient Global Assessment of Disease Activity at Months 3 and 6 | Baseline, Month 3, Month 6 | The patient's global assessment of disease activity was measured using a 100 mm VAS, where the responses were on a continuous range from 0= managing very well and 100 = managing very poorly. |
| Change From Baseline in HAQ-DI Score at Months 3 and 6 | Baseline, Month 3, Month 6 | The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score is the sum of each question, which ranges from 0 to 60, where higher scores represent higher disease activity. The change from baseline in HAQ-DI score at Month 3 and Month 6 was calculated as the difference between HAQ-D1 score reported at baseline and the HAQ-D1 score reported at Month 3 and Month 6. |
| Change From Baseline in VAS-Fatigue at Months 3 and 6 | Baseline, Month 3, Month 6 | Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 = no fatigue to 100 = extreme fatigue. |
| Change From Baseline in Patient's Assessment of Pain at Months 3 and 6 | Baseline, Month 3, Month 6 | Participants measured the pain intensity due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 = no pain to 100 = unbearable pain. |
| Change From Baseline in Participant Assessment of Morning Stiffness Using VAS at Months 3 and 6 | Baseline, Month 3, Month 6 | The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS, where the responses were on a continuous range from 0 = no stiffness and 100 = maximum stiffness. |
| Simplified Disease Activity Index (SDAI) Score by Visit | Baseline, Month 3, Month 6 | The SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in centimeters) + PhGH (in centimeters) + CRP (in mg/dL), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 = no arthritis activity and 100 = extremely active arthritis, CRP = serum concentration of c-reactive protein; with a total SDAI score ranged from 0-86. Higher scores indicate greater disease activity. SDAI scores of less than or equal to 3.3 represents clinical remission, less than or equal to 11.0 represents low disease activity, less than or equal to 26.0 represents moderate disease activity, and greater than 26.0 represents high (or severe) disease. |
| Median Dose at Month 6 | Month 6 | — |
| Percentage of Participants With Tocilizumab Dose Changed According to the Reason for Change | Baseline up to Month 6 | Percentage of participants with increase or decrease in tocilizumab administration according to the reason for dose modification was reported. |
| Mean Dosing Interval at Month 6 | Month 6 | The time interval between two successive doses in days was reported. |
| Percentage of Participants With Reasons Who Discontinued Tocilizumab | Baseline up to Month 6 | — |
| Time to Restoration of Initial Dosing Regimen | Baseline up to Month 6 | — |
| Percentage of Participants by Reason for Choice of Monotherapy at Baseline | Baseline up to Month 6 | — |
| Percentage of Participants on Tocilizumab Monotherapy (8 mg/Kg) at Baseline and at Month 6 | Baseline, Month 6 | — |
Countries
Australia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| RA Participants (All Groups) Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months. | 37 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Other | 2 |
Baseline characteristics
| Characteristic | RA Participants (All Groups) |
|---|---|
| Age, Continuous | 59.3 years STANDARD_DEVIATION 10.62 |
| Sex: Female, Male Female | 21 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 | 12 / 37 |
| serious Total, serious adverse events | 2 / 37 |
Outcome results
Primary
C-Reactive Protein (CRP) at Baseline
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time frame: Baseline
Population: FAS population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RA Participants (Biologic Naïve Group) | C-Reactive Protein (CRP) at Baseline | 15.3 milligrams per liter (mg/L) | Standard Deviation 17.36 |
| RA Participants (Biologic Exposed Group) | C-Reactive Protein (CRP) at Baseline | 22.6 milligrams per liter (mg/L) | Standard Deviation 42.91 |
| RA Participants (Monotherapy Group) | C-Reactive Protein (CRP) at Baseline | 22.5 milligrams per liter (mg/L) | Standard Deviation 24.3 |
| RA Participants (Combination Therapy Group) | C-Reactive Protein (CRP) at Baseline | 16.0 milligrams per liter (mg/L) | Standard Deviation 24.84 |
| RA Participants (All Groups) | C-Reactive Protein (CRP) at Baseline | 16.9 milligrams per liter (mg/L) | Standard Deviation 24.53 |
Primary
Erythrocyte Sedimentation Rate (ESR) at Baseline
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeters per hour (mm/hr). A decrease in the level indicates reduction in inflammation and therefore improvement.
Time frame: Baseline
Population: FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RA Participants (Biologic Naïve Group) | Erythrocyte Sedimentation Rate (ESR) at Baseline | 27.0 mm/hr | Standard Deviation 24.79 |
| RA Participants (Biologic Exposed Group) | Erythrocyte Sedimentation Rate (ESR) at Baseline | 35.2 mm/hr | Standard Deviation 36.78 |
| RA Participants (Monotherapy Group) | Erythrocyte Sedimentation Rate (ESR) at Baseline | 34.8 mm/hr | Standard Deviation 26.79 |
| RA Participants (Combination Therapy Group) | Erythrocyte Sedimentation Rate (ESR) at Baseline | 27.3 mm/hr | Standard Deviation 27.04 |
| RA Participants (All Groups) | Erythrocyte Sedimentation Rate (ESR) at Baseline | 28.4 mm/hr | Standard Deviation 26.74 |
Primary
Health Assessment Questionnaire Disability Index (HAQ-DI) Scores at Baseline
The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question is evaluated according to the degree of severity on a 4-point scale. Total score for HAQ-DI is the average of all questions and ranges from 0 = without any difficulty to 3 = unable to do.
Time frame: Baseline
Population: FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RA Participants (Biologic Naïve Group) | Health Assessment Questionnaire Disability Index (HAQ-DI) Scores at Baseline | 1.7 units on a scale | Standard Deviation 0.86 |
| RA Participants (Biologic Exposed Group) | Health Assessment Questionnaire Disability Index (HAQ-DI) Scores at Baseline | 1.7 units on a scale | Standard Deviation 0.98 |
| RA Participants (Monotherapy Group) | Health Assessment Questionnaire Disability Index (HAQ-DI) Scores at Baseline | 1.7 units on a scale | Standard Deviation 0.59 |
| RA Participants (Combination Therapy Group) | Health Assessment Questionnaire Disability Index (HAQ-DI) Scores at Baseline | 1.7 units on a scale | Standard Deviation 0.9 |
| RA Participants (All Groups) | Health Assessment Questionnaire Disability Index (HAQ-DI) Scores at Baseline | 1.7 units on a scale | Standard Deviation 0.87 |
Primary
Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline
Participants measured the pain intensity due to RA on a 100 millimeter (mm) VAS, where the responses were on a continuous range from 0 = no pain to 100 = unbearable pain.
Time frame: Baseline
Population: FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RA Participants (Biologic Naïve Group) | Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline | 60.1 millimeters (mm) | Standard Deviation 31.08 |
| RA Participants (Biologic Exposed Group) | Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline | 47.2 millimeters (mm) | Standard Deviation 31.93 |
| RA Participants (Monotherapy Group) | Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline | 79.3 millimeters (mm) | Standard Deviation 19.55 |
| RA Participants (Combination Therapy Group) | Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline | 55.3 millimeters (mm) | Standard Deviation 31.49 |
| RA Participants (All Groups) | Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline | 57.6 millimeters (mm) | Standard Deviation 31.14 |
Primary
Patient Global Assessment of Disease Activity Using VAS at Baseline
The patient's global assessment of disease activity was measured using a 100 mm VAS, where the responses were on a continuous range from 0 = managing very well to 100 = managing very poorly.
Time frame: Baseline
Population: FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RA Participants (Biologic Naïve Group) | Patient Global Assessment of Disease Activity Using VAS at Baseline | 69.6 mm | Standard Deviation 29.71 |
| RA Participants (Biologic Exposed Group) | Patient Global Assessment of Disease Activity Using VAS at Baseline | 59.0 mm | Standard Deviation 33.03 |
| RA Participants (Monotherapy Group) | Patient Global Assessment of Disease Activity Using VAS at Baseline | 85.0 mm | Standard Deviation 11.36 |
| RA Participants (Combination Therapy Group) | Patient Global Assessment of Disease Activity Using VAS at Baseline | 65.5 mm | Standard Deviation 31.02 |
| RA Participants (All Groups) | Patient Global Assessment of Disease Activity Using VAS at Baseline | 67.5 mm | Standard Deviation 30.11 |
Primary
Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation
Percentage of participants on tocilizumab treatment at Month 6 was calculated as: \[(participants on tocilizumab treatment at Month 6) divided by (participants evaluable for primary objective)\] multiplied by 100.
Time frame: Month 6
Population: FAS population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RA Participants (Biologic Naïve Group) | Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation | 79.3 percentage of participants |
| RA Participants (Biologic Exposed Group) | Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation | 100 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation | 80 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation | 84.4 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation | 83.8 percentage of participants |
Primary
Physician Global Assessment of Disease Activity Using VAS at Baseline
Physician global assessment of disease activity was assessed on a 100 mm VAS, where 0 = no arthritis activity to 100 = extremely active arthritis.
Time frame: Baseline
Population: FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RA Participants (Biologic Naïve Group) | Physician Global Assessment of Disease Activity Using VAS at Baseline | 65.2 mm | Standard Deviation 24.53 |
| RA Participants (Biologic Exposed Group) | Physician Global Assessment of Disease Activity Using VAS at Baseline | 63.3 mm | Standard Deviation 9.61 |
| RA Participants (Monotherapy Group) | Physician Global Assessment of Disease Activity Using VAS at Baseline | 69.0 mm | Standard Deviation 9 |
| RA Participants (Combination Therapy Group) | Physician Global Assessment of Disease Activity Using VAS at Baseline | 64.4 mm | Standard Deviation 23.33 |
| RA Participants (All Groups) | Physician Global Assessment of Disease Activity Using VAS at Baseline | 64.9 mm | Standard Deviation 22.3 |
Primary
Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline
TJC was determined by examining 28 and 68 joints and identifying the joints that were painful under pressure or to passive motion. Tenderness was recorded on the joint assessment form at baseline, no tenderness = 0, tenderness = 1. SJC was determined by examining 28 and 66 joints and identifying when swelling was present. Swelling was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1.
Time frame: Baseline
Population: FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data for the specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RA Participants (Biologic Naïve Group) | Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline | TJC28 (n= 27, 6, 4, 29, 33) | 15.6 joint counts | Standard Deviation 7.68 |
| RA Participants (Biologic Naïve Group) | Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline | TJC68 (n= 18, 5, 2, 21, 23) | 34.4 joint counts | Standard Deviation 16.97 |
| RA Participants (Biologic Naïve Group) | Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline | SJC28 (n= 27, 6, 4, 29, 33) | 14.0 joint counts | Standard Deviation 6.66 |
| RA Participants (Biologic Naïve Group) | Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline | SJC66 (n= 18, 5, 2, 21, 23) | 27.7 joint counts | Standard Deviation 13.73 |
| RA Participants (Biologic Exposed Group) | Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline | TJC28 (n= 27, 6, 4, 29, 33) | 14.7 joint counts | Standard Deviation 8.48 |
| RA Participants (Biologic Exposed Group) | Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline | SJC66 (n= 18, 5, 2, 21, 23) | 21.0 joint counts | Standard Deviation 13.62 |
| RA Participants (Biologic Exposed Group) | Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline | TJC68 (n= 18, 5, 2, 21, 23) | 24.2 joint counts | Standard Deviation 18.43 |
| RA Participants (Biologic Exposed Group) | Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline | SJC28 (n= 27, 6, 4, 29, 33) | 14.0 joint counts | Standard Deviation 7.51 |
| RA Participants (Monotherapy Group) | Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline | SJC66 (n= 18, 5, 2, 21, 23) | 26.5 joint counts | Standard Deviation 7.78 |
| RA Participants (Monotherapy Group) | Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline | TJC68 (n= 18, 5, 2, 21, 23) | 26.0 joint counts | Standard Deviation 7.07 |
| RA Participants (Monotherapy Group) | Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline | SJC28 (n= 27, 6, 4, 29, 33) | 12.5 joint counts | Standard Deviation 3.79 |
| RA Participants (Monotherapy Group) | Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline | TJC28 (n= 27, 6, 4, 29, 33) | 13.0 joint counts | Standard Deviation 8.41 |
| RA Participants (Combination Therapy Group) | Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline | TJC28 (n= 27, 6, 4, 29, 33) | 15.8 joint counts | Standard Deviation 7.69 |
| RA Participants (Combination Therapy Group) | Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline | TJC68 (n= 18, 5, 2, 21, 23) | 32.8 joint counts | Standard Deviation 18.07 |
| RA Participants (Combination Therapy Group) | Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline | SJC66 (n= 18, 5, 2, 21, 23) | 26.2 joint counts | Standard Deviation 14.25 |
| RA Participants (Combination Therapy Group) | Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline | SJC28 (n= 27, 6, 4, 29, 33) | 14.2 joint counts | Standard Deviation 7.03 |
| RA Participants (All Groups) | Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline | SJC66 (n= 18, 5, 2, 21, 23) | 26.3 joint counts | Standard Deviation 13.69 |
| RA Participants (All Groups) | Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline | SJC28 (n= 27, 6, 4, 29, 33) | 14.0 joint counts | Standard Deviation 6.7 |
| RA Participants (All Groups) | Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline | TJC68 (n= 18, 5, 2, 21, 23) | 32.2 joint counts | Standard Deviation 17.4 |
| RA Participants (All Groups) | Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline | TJC28 (n= 27, 6, 4, 29, 33) | 15.4 joint counts | Standard Deviation 7.7 |
Secondary
Change From Baseline in HAQ-DI Score at Months 3 and 6
The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score is the sum of each question, which ranges from 0 to 60, where higher scores represent higher disease activity. The change from baseline in HAQ-DI score at Month 3 and Month 6 was calculated as the difference between HAQ-D1 score reported at baseline and the HAQ-D1 score reported at Month 3 and Month 6.
Time frame: Baseline, Month 3, Month 6
Population: FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n = participants with available HAQ-DI score at specified visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RA Participants (Biologic Naïve Group) | Change From Baseline in HAQ-DI Score at Months 3 and 6 | Baseline (n= 24, 6, 3, 27, 30) | 1.7 units on a scale | Standard Deviation 0.86 |
| RA Participants (Biologic Naïve Group) | Change From Baseline in HAQ-DI Score at Months 3 and 6 | Change at Month 6 (n= 12, 2, 2, 12, 14) | -0.3 units on a scale | Standard Deviation 0.48 |
| RA Participants (Biologic Naïve Group) | Change From Baseline in HAQ-DI Score at Months 3 and 6 | Change at Month 3 (n= 16, 4, 2, 18, 20) | -0.5 units on a scale | Standard Deviation 0.94 |
| RA Participants (Biologic Exposed Group) | Change From Baseline in HAQ-DI Score at Months 3 and 6 | Change at Month 3 (n= 16, 4, 2, 18, 20) | -0.4 units on a scale | Standard Deviation 0.37 |
| RA Participants (Biologic Exposed Group) | Change From Baseline in HAQ-DI Score at Months 3 and 6 | Baseline (n= 24, 6, 3, 27, 30) | 1.7 units on a scale | Standard Deviation 0.98 |
| RA Participants (Biologic Exposed Group) | Change From Baseline in HAQ-DI Score at Months 3 and 6 | Change at Month 6 (n= 12, 2, 2, 12, 14) | -0.6 units on a scale | Standard Deviation 0.35 |
| RA Participants (Monotherapy Group) | Change From Baseline in HAQ-DI Score at Months 3 and 6 | Change at Month 3 (n= 16, 4, 2, 18, 20) | -0.3 units on a scale | Standard Deviation 0.35 |
| RA Participants (Monotherapy Group) | Change From Baseline in HAQ-DI Score at Months 3 and 6 | Baseline (n= 24, 6, 3, 27, 30) | 1.7 units on a scale | Standard Deviation 0.59 |
| RA Participants (Monotherapy Group) | Change From Baseline in HAQ-DI Score at Months 3 and 6 | Change at Month 6 (n= 12, 2, 2, 12, 14) | -0.4 units on a scale | Standard Deviation 0.09 |
| RA Participants (Combination Therapy Group) | Change From Baseline in HAQ-DI Score at Months 3 and 6 | Baseline (n= 24, 6, 3, 27, 30) | 1.7 units on a scale | Standard Deviation 0.9 |
| RA Participants (Combination Therapy Group) | Change From Baseline in HAQ-DI Score at Months 3 and 6 | Change at Month 6 (n= 12, 2, 2, 12, 14) | -0.3 units on a scale | Standard Deviation 0.51 |
| RA Participants (Combination Therapy Group) | Change From Baseline in HAQ-DI Score at Months 3 and 6 | Change at Month 3 (n= 16, 4, 2, 18, 20) | -0.5 units on a scale | Standard Deviation 0.89 |
| RA Participants (All Groups) | Change From Baseline in HAQ-DI Score at Months 3 and 6 | Change at Month 3 (n= 16, 4, 2, 18, 20) | -0.5 units on a scale | Standard Deviation 0.85 |
| RA Participants (All Groups) | Change From Baseline in HAQ-DI Score at Months 3 and 6 | Baseline (n= 24, 6, 3, 27, 30) | 1.7 units on a scale | Standard Deviation 0.87 |
| RA Participants (All Groups) | Change From Baseline in HAQ-DI Score at Months 3 and 6 | Change at Month 6 (n= 12, 2, 2, 12, 14) | -0.3 units on a scale | Standard Deviation 0.46 |
Secondary
Change From Baseline in Participant Assessment of Morning Stiffness Using VAS at Months 3 and 6
The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS, where the responses were on a continuous range from 0 = no stiffness and 100 = maximum stiffness.
Time frame: Baseline, Month 3, Month 6
Population: FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RA Participants (Biologic Naïve Group) | Change From Baseline in Participant Assessment of Morning Stiffness Using VAS at Months 3 and 6 | Baseline (n= 25, 6, 3, 28, 31) | 65.6 mm | Standard Deviation 31.29 |
| RA Participants (Biologic Naïve Group) | Change From Baseline in Participant Assessment of Morning Stiffness Using VAS at Months 3 and 6 | Change at Month 6 (n= 12, 2, 2, 12, 14) | -30.2 mm | Standard Deviation 35.88 |
| RA Participants (Biologic Naïve Group) | Change From Baseline in Participant Assessment of Morning Stiffness Using VAS at Months 3 and 6 | Change at Month 3 (n= 15, 4, 2, 17, 19) | -30.7 mm | Standard Deviation 37.88 |
| RA Participants (Biologic Exposed Group) | Change From Baseline in Participant Assessment of Morning Stiffness Using VAS at Months 3 and 6 | Change at Month 3 (n= 15, 4, 2, 17, 19) | -34.0 mm | Standard Deviation 17.8 |
| RA Participants (Biologic Exposed Group) | Change From Baseline in Participant Assessment of Morning Stiffness Using VAS at Months 3 and 6 | Baseline (n= 25, 6, 3, 28, 31) | 57.3 mm | Standard Deviation 29.92 |
| RA Participants (Biologic Exposed Group) | Change From Baseline in Participant Assessment of Morning Stiffness Using VAS at Months 3 and 6 | Change at Month 6 (n= 12, 2, 2, 12, 14) | -38.0 mm | Standard Deviation 14.14 |
| RA Participants (Monotherapy Group) | Change From Baseline in Participant Assessment of Morning Stiffness Using VAS at Months 3 and 6 | Change at Month 3 (n= 15, 4, 2, 17, 19) | -42.5 mm | Standard Deviation 14.85 |
| RA Participants (Monotherapy Group) | Change From Baseline in Participant Assessment of Morning Stiffness Using VAS at Months 3 and 6 | Baseline (n= 25, 6, 3, 28, 31) | 77.3 mm | Standard Deviation 22.03 |
| RA Participants (Monotherapy Group) | Change From Baseline in Participant Assessment of Morning Stiffness Using VAS at Months 3 and 6 | Change at Month 6 (n= 12, 2, 2, 12, 14) | -31.5 mm | Standard Deviation 4.95 |
| RA Participants (Combination Therapy Group) | Change From Baseline in Participant Assessment of Morning Stiffness Using VAS at Months 3 and 6 | Baseline (n= 25, 6, 3, 28, 31) | 62.5 mm | Standard Deviation 31.46 |
| RA Participants (Combination Therapy Group) | Change From Baseline in Participant Assessment of Morning Stiffness Using VAS at Months 3 and 6 | Change at Month 6 (n= 12, 2, 2, 12, 14) | -31.3 mm | Standard Deviation 36.23 |
| RA Participants (Combination Therapy Group) | Change From Baseline in Participant Assessment of Morning Stiffness Using VAS at Months 3 and 6 | Change at Month 3 (n= 15, 4, 2, 17, 19) | -30.1 mm | Standard Deviation 35.86 |
| RA Participants (All Groups) | Change From Baseline in Participant Assessment of Morning Stiffness Using VAS at Months 3 and 6 | Change at Month 3 (n= 15, 4, 2, 17, 19) | -31.4 mm | Standard Deviation 34.21 |
| RA Participants (All Groups) | Change From Baseline in Participant Assessment of Morning Stiffness Using VAS at Months 3 and 6 | Baseline (n= 25, 6, 3, 28, 31) | 64.0 mm | Standard Deviation 30.71 |
| RA Participants (All Groups) | Change From Baseline in Participant Assessment of Morning Stiffness Using VAS at Months 3 and 6 | Change at Month 6 (n= 12, 2, 2, 12, 14) | -31.3 mm | Standard Deviation 33.35 |
Secondary
Change From Baseline in Patient Global Assessment of Disease Activity at Months 3 and 6
The patient's global assessment of disease activity was measured using a 100 mm VAS, where the responses were on a continuous range from 0= managing very well and 100 = managing very poorly.
Time frame: Baseline, Month 3, Month 6
Population: FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RA Participants (Biologic Naïve Group) | Change From Baseline in Patient Global Assessment of Disease Activity at Months 3 and 6 | Baseline (n=24, 6, 3, 27, 30) | 69.6 mm | Standard Deviation 29.71 |
| RA Participants (Biologic Naïve Group) | Change From Baseline in Patient Global Assessment of Disease Activity at Months 3 and 6 | Change at Month 3 (n= 16, 4, 2, 18, 20 ) | -43.2 mm | Standard Deviation 35.87 |
| RA Participants (Biologic Naïve Group) | Change From Baseline in Patient Global Assessment of Disease Activity at Months 3 and 6 | Change at Month 6 (n= 13, 2, 2, 13, 15) | -26.4 mm | Standard Deviation 31.28 |
| RA Participants (Biologic Exposed Group) | Change From Baseline in Patient Global Assessment of Disease Activity at Months 3 and 6 | Change at Month 6 (n= 13, 2, 2, 13, 15) | -37.0 mm | Standard Deviation 33.94 |
| RA Participants (Biologic Exposed Group) | Change From Baseline in Patient Global Assessment of Disease Activity at Months 3 and 6 | Baseline (n=24, 6, 3, 27, 30) | 59.0 mm | Standard Deviation 33.03 |
| RA Participants (Biologic Exposed Group) | Change From Baseline in Patient Global Assessment of Disease Activity at Months 3 and 6 | Change at Month 3 (n= 16, 4, 2, 18, 20 ) | -34.5 mm | Standard Deviation 18.7 |
| RA Participants (Monotherapy Group) | Change From Baseline in Patient Global Assessment of Disease Activity at Months 3 and 6 | Change at Month 6 (n= 13, 2, 2, 13, 15) | -32.0 mm | Standard Deviation 26.87 |
| RA Participants (Monotherapy Group) | Change From Baseline in Patient Global Assessment of Disease Activity at Months 3 and 6 | Change at Month 3 (n= 16, 4, 2, 18, 20 ) | -50.0 mm | Standard Deviation 16.97 |
| RA Participants (Monotherapy Group) | Change From Baseline in Patient Global Assessment of Disease Activity at Months 3 and 6 | Baseline (n=24, 6, 3, 27, 30) | 85.0 mm | Standard Deviation 11.36 |
| RA Participants (Combination Therapy Group) | Change From Baseline in Patient Global Assessment of Disease Activity at Months 3 and 6 | Baseline (n=24, 6, 3, 27, 30) | 65.5 mm | Standard Deviation 31.02 |
| RA Participants (Combination Therapy Group) | Change From Baseline in Patient Global Assessment of Disease Activity at Months 3 and 6 | Change at Month 3 (n= 16, 4, 2, 18, 20 ) | -40.5 mm | Standard Deviation 34.42 |
| RA Participants (Combination Therapy Group) | Change From Baseline in Patient Global Assessment of Disease Activity at Months 3 and 6 | Change at Month 6 (n= 13, 2, 2, 13, 15) | -27.2 mm | Standard Deviation 32.05 |
| RA Participants (All Groups) | Change From Baseline in Patient Global Assessment of Disease Activity at Months 3 and 6 | Baseline (n=24, 6, 3, 27, 30) | 67.5 mm | Standard Deviation 30.11 |
| RA Participants (All Groups) | Change From Baseline in Patient Global Assessment of Disease Activity at Months 3 and 6 | Change at Month 6 (n= 13, 2, 2, 13, 15) | -27.8 mm | Standard Deviation 30.57 |
| RA Participants (All Groups) | Change From Baseline in Patient Global Assessment of Disease Activity at Months 3 and 6 | Change at Month 3 (n= 16, 4, 2, 18, 20 ) | -41.5 mm | Standard Deviation 32.92 |
Secondary
Change From Baseline in Patient's Assessment of Pain at Months 3 and 6
Participants measured the pain intensity due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 = no pain to 100 = unbearable pain.
Time frame: Baseline, Month 3, Month 6
Population: FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n = participants with available data for the specified visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RA Participants (Biologic Naïve Group) | Change From Baseline in Patient's Assessment of Pain at Months 3 and 6 | Baseline (n= 25, 6, 3, 28, 31) | 60.1 mm | Standard Deviation 31.08 |
| RA Participants (Biologic Naïve Group) | Change From Baseline in Patient's Assessment of Pain at Months 3 and 6 | Change at Month 6 (n= 13, 2, 2, 13, 15) | -32.3 mm | Standard Deviation 34.88 |
| RA Participants (Biologic Naïve Group) | Change From Baseline in Patient's Assessment of Pain at Months 3 and 6 | Change at Month 3 (n= 16, 4, 2, 18, 20) | -35.6 mm | Standard Deviation 39.39 |
| RA Participants (Biologic Exposed Group) | Change From Baseline in Patient's Assessment of Pain at Months 3 and 6 | Change at Month 3 (n= 16, 4, 2, 18, 20) | -15.8 mm | Standard Deviation 26.99 |
| RA Participants (Biologic Exposed Group) | Change From Baseline in Patient's Assessment of Pain at Months 3 and 6 | Baseline (n= 25, 6, 3, 28, 31) | 47.2 mm | Standard Deviation 31.93 |
| RA Participants (Biologic Exposed Group) | Change From Baseline in Patient's Assessment of Pain at Months 3 and 6 | Change at Month 6 (n= 13, 2, 2, 13, 15) | -47.0 mm | Standard Deviation 14.14 |
| RA Participants (Monotherapy Group) | Change From Baseline in Patient's Assessment of Pain at Months 3 and 6 | Change at Month 3 (n= 16, 4, 2, 18, 20) | -39.5 mm | Standard Deviation 14.85 |
| RA Participants (Monotherapy Group) | Change From Baseline in Patient's Assessment of Pain at Months 3 and 6 | Baseline (n= 25, 6, 3, 28, 31) | 79.3 mm | Standard Deviation 19.55 |
| RA Participants (Monotherapy Group) | Change From Baseline in Patient's Assessment of Pain at Months 3 and 6 | Change at Month 6 (n= 13, 2, 2, 13, 15) | -51.5 mm | Standard Deviation 7.78 |
| RA Participants (Combination Therapy Group) | Change From Baseline in Patient's Assessment of Pain at Months 3 and 6 | Baseline (n= 25, 6, 3, 28, 31) | 55.3 mm | Standard Deviation 31.49 |
| RA Participants (Combination Therapy Group) | Change From Baseline in Patient's Assessment of Pain at Months 3 and 6 | Change at Month 6 (n= 13, 2, 2, 13, 15) | -31.6 mm | Standard Deviation 34.68 |
| RA Participants (Combination Therapy Group) | Change From Baseline in Patient's Assessment of Pain at Months 3 and 6 | Change at Month 3 (n= 16, 4, 2, 18, 20) | -30.8 mm | Standard Deviation 39.38 |
| RA Participants (All Groups) | Change From Baseline in Patient's Assessment of Pain at Months 3 and 6 | Change at Month 3 (n= 16, 4, 2, 18, 20) | -31.17 mm | Standard Deviation 37.5 |
| RA Participants (All Groups) | Change From Baseline in Patient's Assessment of Pain at Months 3 and 6 | Baseline (n= 25, 6, 3, 28, 31) | 57.6 mm | Standard Deviation 31.14 |
| RA Participants (All Groups) | Change From Baseline in Patient's Assessment of Pain at Months 3 and 6 | Change at Month 6 (n= 13, 2, 2, 13, 15) | -34.3 mm | Standard Deviation 32.93 |
Secondary
Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6
The physician global assessment of disease activity was evaluated using a 100 mm VAS where 0 = no arthritis activity and 100 = extremely active arthritis. Higher scores indicated increased level of disease.
Time frame: Baseline, Month 3, Month 6
Population: FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RA Participants (Biologic Naïve Group) | Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6 | Baseline (n= 25, 6, 3, 28, 31) | 65.2 mm | Standard Deviation 24.53 |
| RA Participants (Biologic Naïve Group) | Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6 | Change at Month 6 (n= 13, 2, 2, 13, 15) | -35.2 mm | Standard Deviation 28.12 |
| RA Participants (Biologic Naïve Group) | Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6 | Change at Month 3 (n= 13, 4, 2, 15, 17) | -40.8 mm | Standard Deviation 24.07 |
| RA Participants (Biologic Exposed Group) | Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6 | Change at Month 3 (n= 13, 4, 2, 15, 17) | -33.8 mm | Standard Deviation 11.56 |
| RA Participants (Biologic Exposed Group) | Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6 | Baseline (n= 25, 6, 3, 28, 31) | 63.3 mm | Standard Deviation 9.61 |
| RA Participants (Biologic Exposed Group) | Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6 | Change at Month 6 (n= 13, 2, 2, 13, 15) | -38.5 mm | Standard Deviation 13.44 |
| RA Participants (Monotherapy Group) | Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6 | Change at Month 3 (n= 13, 4, 2, 15, 17) | -43.5 mm | Standard Deviation 4.95 |
| RA Participants (Monotherapy Group) | Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6 | Baseline (n= 25, 6, 3, 28, 31) | 69.0 mm | Standard Deviation 9 |
| RA Participants (Monotherapy Group) | Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6 | Change at Month 6 (n= 13, 2, 2, 13, 15) | -45.5 mm | Standard Deviation 23.33 |
| RA Participants (Combination Therapy Group) | Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6 | Baseline (n= 25, 6, 3, 28, 31) | 64.4 mm | Standard Deviation 23.33 |
| RA Participants (Combination Therapy Group) | Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6 | Change at Month 6 (n= 13, 2, 2, 13, 15) | -34.2 mm | Standard Deviation 27.27 |
| RA Participants (Combination Therapy Group) | Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6 | Change at Month 3 (n= 13, 4, 2, 15, 17) | -38.6 mm | Standard Deviation 23.05 |
| RA Participants (All Groups) | Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6 | Change at Month 3 (n= 13, 4, 2, 15, 17) | -39.2 mm | Standard Deviation 21.66 |
| RA Participants (All Groups) | Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6 | Baseline (n= 25, 6, 3, 28, 31) | 64.9 mm | Standard Deviation 22.3 |
| RA Participants (All Groups) | Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6 | Change at Month 6 (n= 13, 2, 2, 13, 15) | -35.7 mm | Standard Deviation 26.31 |
Secondary
Change From Baseline in TJC and SJC at Month 3 and Month 6
TJC was determined by examining 28 and 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at baseline, no tenderness = 0, tenderness = 1. SJC was determined by examination of 28 and 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1.
Time frame: Baseline, Month 3, Month 6
Population: FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RA Participants (Biologic Naïve Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | SJC28: Change at Month 3 (n= 14, 4, 3, 15, 18) | -13.8 joint counts | Standard Deviation 4.54 |
| RA Participants (Biologic Naïve Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | SJC66: Change at Month 3 (n= 11, 3, 2, 12, 14) | -27.2 joint counts | Standard Deviation 9.58 |
| RA Participants (Biologic Naïve Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | TJC28: Baseline (n= 27, 6, 4, 29, 33) | 15.6 joint counts | Standard Deviation 7.68 |
| RA Participants (Biologic Naïve Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | TJC68: Baseline (n= 18, 5, 2, 21, 23 ) | 34.4 joint counts | Standard Deviation 16.97 |
| RA Participants (Biologic Naïve Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | TJC68: Change at Month 6 (n= 11, 1, 2, 10, 12 ) | -27.5 joint counts | Standard Deviation 17.41 |
| RA Participants (Biologic Naïve Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | SJC66: Change at Month 6 (n= 11, 1, 2, 10, 12) | -26.0 joint counts | Standard Deviation 13.8 |
| RA Participants (Biologic Naïve Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | SJC66: Baseline (n= 18, 5, 2, 21, 23) | 27.7 joint counts | Standard Deviation 13.73 |
| RA Participants (Biologic Naïve Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | TJC28: Change at Month 6 (n= 14, 2, 3, 13, 16) | -11.1 joint counts | Standard Deviation 8.56 |
| RA Participants (Biologic Naïve Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | TJC68: Change at Month 3 (n= 11, 3, 2, 12, 14) | -30.5 joint counts | Standard Deviation 8.13 |
| RA Participants (Biologic Naïve Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | SJC28: Baseline (n= 27, 6, 4, 29, 33) | 14.0 joint counts | Standard Deviation 6.66 |
| RA Participants (Biologic Naïve Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | TJC28: Change at Month 3 (n= 14, 4, 3, 15, 18) | -13.9 joint counts | Standard Deviation 5.17 |
| RA Participants (Biologic Naïve Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | SJC28: Change at Month 6 (n= 14, 2, 3, 13, 16) | -10.8 joint counts | Standard Deviation 6.34 |
| RA Participants (Biologic Exposed Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | SJC66: Change at Month 6 (n= 11, 1, 2, 10, 12) | -17.0 joint counts | — |
| RA Participants (Biologic Exposed Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | TJC68: Change at Month 6 (n= 11, 1, 2, 10, 12 ) | -17.0 joint counts | — |
| RA Participants (Biologic Exposed Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | TJC28: Change at Month 3 (n= 14, 4, 3, 15, 18) | -11.0 joint counts | Standard Deviation 6.78 |
| RA Participants (Biologic Exposed Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | SJC28: Baseline (n= 27, 6, 4, 29, 33) | 14.0 joint counts | Standard Deviation 7.51 |
| RA Participants (Biologic Exposed Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | TJC28: Baseline (n= 27, 6, 4, 29, 33) | 14.7 joint counts | Standard Deviation 8.48 |
| RA Participants (Biologic Exposed Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | SJC66: Change at Month 3 (n= 11, 3, 2, 12, 14) | -12.7 joint counts | Standard Deviation 5.51 |
| RA Participants (Biologic Exposed Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | TJC28: Change at Month 6 (n= 14, 2, 3, 13, 16) | -15.0 joint counts | Standard Deviation 7.07 |
| RA Participants (Biologic Exposed Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | SJC28: Change at Month 3 (n= 14, 4, 3, 15, 18) | -10.5 joint counts | Standard Deviation 6.81 |
| RA Participants (Biologic Exposed Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | SJC66: Baseline (n= 18, 5, 2, 21, 23) | 21.0 joint counts | Standard Deviation 13.62 |
| RA Participants (Biologic Exposed Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | TJC68: Baseline (n= 18, 5, 2, 21, 23 ) | 24.2 joint counts | Standard Deviation 18.43 |
| RA Participants (Biologic Exposed Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | SJC28: Change at Month 6 (n= 14, 2, 3, 13, 16) | -13.5 joint counts | Standard Deviation 4.95 |
| RA Participants (Biologic Exposed Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | TJC68: Change at Month 3 (n= 11, 3, 2, 12, 14) | -12.3 joint counts | Standard Deviation 6.66 |
| RA Participants (Monotherapy Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | SJC66: Change at Month 3 (n= 11, 3, 2, 12, 14) | -18.5 joint counts | Standard Deviation 13.44 |
| RA Participants (Monotherapy Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | TJC28: Baseline (n= 27, 6, 4, 29, 33) | 13.0 joint counts | Standard Deviation 8.41 |
| RA Participants (Monotherapy Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | TJC28: Change at Month 3 (n= 14, 4, 3, 15, 18) | -7.0 joint counts | Standard Deviation 5.57 |
| RA Participants (Monotherapy Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | TJC28: Change at Month 6 (n= 14, 2, 3, 13, 16) | -8.3 joint counts | Standard Deviation 6.66 |
| RA Participants (Monotherapy Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | TJC68: Baseline (n= 18, 5, 2, 21, 23 ) | 26.0 joint counts | Standard Deviation 7.07 |
| RA Participants (Monotherapy Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | TJC68: Change at Month 3 (n= 11, 3, 2, 12, 14) | -18.0 joint counts | Standard Deviation 12.73 |
| RA Participants (Monotherapy Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | TJC68: Change at Month 6 (n= 11, 1, 2, 10, 12 ) | -21.5 joint counts | Standard Deviation 6.36 |
| RA Participants (Monotherapy Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | SJC28: Baseline (n= 27, 6, 4, 29, 33) | 12.5 joint counts | Standard Deviation 3.79 |
| RA Participants (Monotherapy Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | SJC28: Change at Month 3 (n= 14, 4, 3, 15, 18) | -9.3 joint counts | Standard Deviation 5.51 |
| RA Participants (Monotherapy Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | SJC28: Change at Month 6 (n= 14, 2, 3, 13, 16) | -11.7 joint counts | Standard Deviation 2.89 |
| RA Participants (Monotherapy Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | SJC66: Baseline (n= 18, 5, 2, 21, 23) | 26.5 joint counts | Standard Deviation 7.78 |
| RA Participants (Monotherapy Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | SJC66: Change at Month 6 (n= 11, 1, 2, 10, 12) | -21.5 joint counts | Standard Deviation 6.36 |
| RA Participants (Combination Therapy Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | TJC68: Change at Month 6 (n= 11, 1, 2, 10, 12 ) | -27.7 joint counts | Standard Deviation 18.34 |
| RA Participants (Combination Therapy Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | TJC28: Baseline (n= 27, 6, 4, 29, 33) | 15.8 joint counts | Standard Deviation 7.69 |
| RA Participants (Combination Therapy Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | SJC28: Change at Month 3 (n= 14, 4, 3, 15, 18) | -13.8 joint counts | Standard Deviation 4.86 |
| RA Participants (Combination Therapy Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | TJC68: Change at Month 3 (n= 11, 3, 2, 12, 14) | -28.1 joint counts | Standard Deviation 10.42 |
| RA Participants (Combination Therapy Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | SJC28: Change at Month 6 (n= 14, 2, 3, 13, 16) | -11.0 joint counts | Standard Deviation 6.72 |
| RA Participants (Combination Therapy Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | TJC68: Baseline (n= 18, 5, 2, 21, 23 ) | 32.8 joint counts | Standard Deviation 18.07 |
| RA Participants (Combination Therapy Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | SJC66: Change at Month 6 (n= 11, 1, 2, 10, 12) | -26.0 joint counts | Standard Deviation 14.54 |
| RA Participants (Combination Therapy Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | SJC66: Baseline (n= 18, 5, 2, 21, 23) | 26.2 joint counts | Standard Deviation 14.25 |
| RA Participants (Combination Therapy Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | TJC28: Change at Month 6 (n= 14, 2, 3, 13, 16) | -12.3 joint counts | Standard Deviation 8.67 |
| RA Participants (Combination Therapy Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | TJC28: Change at Month 3 (n= 14, 4, 3, 15, 18) | -14.5 joint counts | Standard Deviation 4.7 |
| RA Participants (Combination Therapy Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | SJC66: Change at Month 3 (n= 11, 3, 2, 12, 14) | -25.0 joint counts | Standard Deviation 10.54 |
| RA Participants (Combination Therapy Group) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | SJC28: Baseline (n= 27, 6, 4, 29, 33) | 14.2 joint counts | Standard Deviation 7.03 |
| RA Participants (All Groups) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | TJC68: Change at Month 6 (n= 11, 1, 2, 10, 12 ) | -26.7 joint counts | Standard Deviation 16.88 |
| RA Participants (All Groups) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | SJC66: Baseline (n= 18, 5, 2, 21, 23) | 26.3 joint counts | Standard Deviation 13.69 |
| RA Participants (All Groups) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | TJC28: Baseline (n= 27, 6, 4, 29, 33) | 15.4 joint counts | Standard Deviation 7.7 |
| RA Participants (All Groups) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | SJC28: Change at Month 3 (n= 14, 4, 3, 15, 18) | -13.1 joint counts | Standard Deviation 5.09 |
| RA Participants (All Groups) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | TJC28: Change at Month 3 (n= 14, 4, 3, 15, 18) | -13.2 joint counts | Standard Deviation 5.48 |
| RA Participants (All Groups) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | TJC68: Baseline (n= 18, 5, 2, 21, 23 ) | 32.2 joint counts | Standard Deviation 17.4 |
| RA Participants (All Groups) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | SJC66: Change at Month 6 (n= 11, 1, 2, 10, 12) | -25.3 joint counts | Standard Deviation 13.41 |
| RA Participants (All Groups) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | TJC68: Change at Month 3 (n= 11, 3, 2, 12, 14) | -26.6 joint counts | Standard Deviation 10.85 |
| RA Participants (All Groups) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | SJC28: Change at Month 6 (n= 14, 2, 3, 13, 16) | -11.1 joint counts | Standard Deviation 6.11 |
| RA Participants (All Groups) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | SJC28: Baseline (n= 27, 6, 4, 29, 33) | 14.0 joint counts | Standard Deviation 6.7 |
| RA Participants (All Groups) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | TJC28: Change at Month 6 (n= 14, 2, 3, 13, 16) | -11.6 joint counts | Standard Deviation 8.29 |
| RA Participants (All Groups) | Change From Baseline in TJC and SJC at Month 3 and Month 6 | SJC66: Change at Month 3 (n= 11, 3, 2, 12, 14) | -24.1 joint counts | Standard Deviation 10.65 |
Secondary
Change From Baseline in VAS-Fatigue at Months 3 and 6
Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 = no fatigue to 100 = extreme fatigue.
Time frame: Baseline, Month 3, Month 6
Population: FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RA Participants (Biologic Naïve Group) | Change From Baseline in VAS-Fatigue at Months 3 and 6 | Baseline (n= 25, 6, 3, 28, 31) | 59.0 mm | Standard Deviation 34.35 |
| RA Participants (Biologic Naïve Group) | Change From Baseline in VAS-Fatigue at Months 3 and 6 | Change at Month 6 (n=12, 2, 2, 12, 14) | -19.8 mm | Standard Deviation 29.81 |
| RA Participants (Biologic Naïve Group) | Change From Baseline in VAS-Fatigue at Months 3 and 6 | Change at Month 3 (n= 16, 4, 2, 18, 20) | -23.2 mm | Standard Deviation 29.9 |
| RA Participants (Biologic Exposed Group) | Change From Baseline in VAS-Fatigue at Months 3 and 6 | Change at Month 3 (n= 16, 4, 2, 18, 20) | -37.8 mm | Standard Deviation 24.93 |
| RA Participants (Biologic Exposed Group) | Change From Baseline in VAS-Fatigue at Months 3 and 6 | Baseline (n= 25, 6, 3, 28, 31) | 67.8 mm | Standard Deviation 27.01 |
| RA Participants (Biologic Exposed Group) | Change From Baseline in VAS-Fatigue at Months 3 and 6 | Change at Month 6 (n=12, 2, 2, 12, 14) | -34.0 mm | Standard Deviation 22.63 |
| RA Participants (Monotherapy Group) | Change From Baseline in VAS-Fatigue at Months 3 and 6 | Change at Month 3 (n= 16, 4, 2, 18, 20) | -38.5 mm | Standard Deviation 13.44 |
| RA Participants (Monotherapy Group) | Change From Baseline in VAS-Fatigue at Months 3 and 6 | Baseline (n= 25, 6, 3, 28, 31) | 86.3 mm | Standard Deviation 8.08 |
| RA Participants (Monotherapy Group) | Change From Baseline in VAS-Fatigue at Months 3 and 6 | Change at Month 6 (n=12, 2, 2, 12, 14) | -51.5 mm | Standard Deviation 2.12 |
| RA Participants (Combination Therapy Group) | Change From Baseline in VAS-Fatigue at Months 3 and 6 | Baseline (n= 25, 6, 3, 28, 31) | 58.0 mm | Standard Deviation 33.35 |
| RA Participants (Combination Therapy Group) | Change From Baseline in VAS-Fatigue at Months 3 and 6 | Change at Month 6 (n=12, 2, 2, 12, 14) | -16.8 mm | Standard Deviation 27.91 |
| RA Participants (Combination Therapy Group) | Change From Baseline in VAS-Fatigue at Months 3 and 6 | Change at Month 3 (n= 16, 4, 2, 18, 20) | -24.7 mm | Standard Deviation 30.13 |
| RA Participants (All Groups) | Change From Baseline in VAS-Fatigue at Months 3 and 6 | Change at Month 3 (n= 16, 4, 2, 18, 20) | -26.1 mm | Standard Deviation 28.98 |
| RA Participants (All Groups) | Change From Baseline in VAS-Fatigue at Months 3 and 6 | Baseline (n= 25, 6, 3, 28, 31) | 60.7 mm | Standard Deviation 32.84 |
| RA Participants (All Groups) | Change From Baseline in VAS-Fatigue at Months 3 and 6 | Change at Month 6 (n=12, 2, 2, 12, 14) | -21.8 mm | Standard Deviation 28.6 |
Secondary
Clinical Disease Activity Index (CDAI) Score by Visit
The CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in centimeters) + PhGH (in centimeters), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, and PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 = no arthritis activity and 100 = extremely active arthritis; with a total score ranged from 0-76. Higher scores indicate greater disease activity. CDAI score of less than or equal to 2.8 represents clinical remission, score of less than or equal to 10.0 represents low disease activity, score of less than or equal to 22.0 represents moderate disease activity, and score of greater than 22.0 represents high (or severe) disease.
Time frame: Baseline, Month 3, Month 6
Population: FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with CDAI score available at specified visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RA Participants (Biologic Naïve Group) | Clinical Disease Activity Index (CDAI) Score by Visit | Baseline (n= 22, 6, 3, 25, 28) | 46.41 units on a scale | Standard Deviation 16.482 |
| RA Participants (Biologic Naïve Group) | Clinical Disease Activity Index (CDAI) Score by Visit | Month 6 (n= 13, 3, 4, 12, 16) | 13.20 units on a scale | Standard Deviation 15.017 |
| RA Participants (Biologic Naïve Group) | Clinical Disease Activity Index (CDAI) Score by Visit | Month 3 (n= 13, 5, 4, 14, 18) | 12.37 units on a scale | Standard Deviation 10.97 |
| RA Participants (Biologic Exposed Group) | Clinical Disease Activity Index (CDAI) Score by Visit | Month 3 (n= 13, 5, 4, 14, 18) | 16.00 units on a scale | Standard Deviation 5.632 |
| RA Participants (Biologic Exposed Group) | Clinical Disease Activity Index (CDAI) Score by Visit | Baseline (n= 22, 6, 3, 25, 28) | 40.90 units on a scale | Standard Deviation 18.277 |
| RA Participants (Biologic Exposed Group) | Clinical Disease Activity Index (CDAI) Score by Visit | Month 6 (n= 13, 3, 4, 12, 16) | 14.93 units on a scale | Standard Deviation 4.14 |
| RA Participants (Monotherapy Group) | Clinical Disease Activity Index (CDAI) Score by Visit | Month 3 (n= 13, 5, 4, 14, 18) | 13.05 units on a scale | Standard Deviation 7.468 |
| RA Participants (Monotherapy Group) | Clinical Disease Activity Index (CDAI) Score by Visit | Baseline (n= 22, 6, 3, 25, 28) | 45.40 units on a scale | Standard Deviation 4.9 |
| RA Participants (Monotherapy Group) | Clinical Disease Activity Index (CDAI) Score by Visit | Month 6 (n= 13, 3, 4, 12, 16) | 11.30 units on a scale | Standard Deviation 7.338 |
| RA Participants (Combination Therapy Group) | Clinical Disease Activity Index (CDAI) Score by Visit | Baseline (n= 22, 6, 3, 25, 28) | 45.21 units on a scale | Standard Deviation 17.643 |
| RA Participants (Combination Therapy Group) | Clinical Disease Activity Index (CDAI) Score by Visit | Month 6 (n= 13, 3, 4, 12, 16) | 14.27 units on a scale | Standard Deviation 15.254 |
| RA Participants (Combination Therapy Group) | Clinical Disease Activity Index (CDAI) Score by Visit | Month 3 (n= 13, 5, 4, 14, 18) | 13.47 units on a scale | Standard Deviation 10.564 |
| RA Participants (All Groups) | Clinical Disease Activity Index (CDAI) Score by Visit | Month 3 (n= 13, 5, 4, 14, 18) | 13.38 units on a scale | Standard Deviation 9.758 |
| RA Participants (All Groups) | Clinical Disease Activity Index (CDAI) Score by Visit | Baseline (n= 22, 6, 3, 25, 28) | 45.23 units on a scale | Standard Deviation 16.687 |
| RA Participants (All Groups) | Clinical Disease Activity Index (CDAI) Score by Visit | Month 6 (n= 13, 3, 4, 12, 16) | 13.53 units on a scale | Standard Deviation 13.534 |
Secondary
Disease Activity Score Based on 28 Joint Count (DAS28) Score by Visit
The DAS28 score is a measurement of RA activity on a 0 to 10 scale, with higher scores representing higher disease activity, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.70 x natural logarithm (ln) (CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient global assessment of disease activity, which was measured on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly. A score of less than 2.6 represents clinical remission, a score of greater than or equal to 2.6 and less than or equal to 3.2 represents low disease activity, a score of greater than 3.2 and less than or equal to 5.1 represents moderate disease activity, and a score of greater than 5.1 represents high (or severe) disease.
Time frame: Baseline, Month 3, Month 6
Population: FAS population. Here, Number of participants analyzed = Participants evaluable for the outcome measure and n= participants with DAS28 score available at the specified visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RA Participants (Biologic Naïve Group) | Disease Activity Score Based on 28 Joint Count (DAS28) Score by Visit | Baseline (n=22, 6, 3, 25, 28) | 6.34 units on a scale | Standard Deviation 1.611 |
| RA Participants (Biologic Naïve Group) | Disease Activity Score Based on 28 Joint Count (DAS28) Score by Visit | Month 6 (n=12, 2, 2, 12, 14) | 3.02 units on a scale | Standard Deviation 1.459 |
| RA Participants (Biologic Naïve Group) | Disease Activity Score Based on 28 Joint Count (DAS28) Score by Visit | Month 3 (n=13, 4, 2, 15, 17) | 2.69 units on a scale | Standard Deviation 1.274 |
| RA Participants (Biologic Exposed Group) | Disease Activity Score Based on 28 Joint Count (DAS28) Score by Visit | Month 3 (n=13, 4, 2, 15, 17) | 2.98 units on a scale | Standard Deviation 1.25 |
| RA Participants (Biologic Exposed Group) | Disease Activity Score Based on 28 Joint Count (DAS28) Score by Visit | Baseline (n=22, 6, 3, 25, 28) | 6.04 units on a scale | Standard Deviation 1.272 |
| RA Participants (Biologic Exposed Group) | Disease Activity Score Based on 28 Joint Count (DAS28) Score by Visit | Month 6 (n=12, 2, 2, 12, 14) | 2.75 units on a scale | Standard Deviation 1.42 |
| RA Participants (Monotherapy Group) | Disease Activity Score Based on 28 Joint Count (DAS28) Score by Visit | Month 3 (n=13, 4, 2, 15, 17) | 3.61 units on a scale | Standard Deviation 0.151 |
| RA Participants (Monotherapy Group) | Disease Activity Score Based on 28 Joint Count (DAS28) Score by Visit | Baseline (n=22, 6, 3, 25, 28) | 6.73 units on a scale | Standard Deviation 0.868 |
| RA Participants (Monotherapy Group) | Disease Activity Score Based on 28 Joint Count (DAS28) Score by Visit | Month 6 (n=12, 2, 2, 12, 14) | 3.49 units on a scale | Standard Deviation 0.38 |
| RA Participants (Combination Therapy Group) | Disease Activity Score Based on 28 Joint Count (DAS28) Score by Visit | Baseline (n=22, 6, 3, 25, 28) | 6.22 units on a scale | Standard Deviation 1.592 |
| RA Participants (Combination Therapy Group) | Disease Activity Score Based on 28 Joint Count (DAS28) Score by Visit | Month 6 (n=12, 2, 2, 12, 14) | 2.89 units on a scale | Standard Deviation 1.502 |
| RA Participants (Combination Therapy Group) | Disease Activity Score Based on 28 Joint Count (DAS28) Score by Visit | Month 3 (n=13, 4, 2, 15, 17) | 2.64 units on a scale | Standard Deviation 1.275 |
| RA Participants (All Groups) | Disease Activity Score Based on 28 Joint Count (DAS28) Score by Visit | Month 3 (n=13, 4, 2, 15, 17) | 2.76 units on a scale | Standard Deviation 1.236 |
| RA Participants (All Groups) | Disease Activity Score Based on 28 Joint Count (DAS28) Score by Visit | Baseline (n=22, 6, 3, 25, 28) | 6.28 units on a scale | Standard Deviation 1.528 |
| RA Participants (All Groups) | Disease Activity Score Based on 28 Joint Count (DAS28) Score by Visit | Month 6 (n=12, 2, 2, 12, 14) | 2.98 units on a scale | Standard Deviation 1.402 |
Secondary
Duration of Tocilizumab Treatment
Time frame: Baseline up to Month 6
Population: FAS population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RA Participants (Biologic Naïve Group) | Duration of Tocilizumab Treatment | 181.1 days | Standard Deviation 56.31 |
| RA Participants (Biologic Exposed Group) | Duration of Tocilizumab Treatment | 211.3 days | Standard Deviation 28.17 |
| RA Participants (Monotherapy Group) | Duration of Tocilizumab Treatment | 174.8 days | Standard Deviation 48.43 |
| RA Participants (Combination Therapy Group) | Duration of Tocilizumab Treatment | 189.7 days | Standard Deviation 53.79 |
| RA Participants (All Groups) | Duration of Tocilizumab Treatment | 187.6 days | Standard Deviation 52.71 |
Secondary
Mean Dosing Interval at Month 6
The time interval between two successive doses in days was reported.
Time frame: Month 6
Population: FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RA Participants (Biologic Naïve Group) | Mean Dosing Interval at Month 6 | 30.97 days | Standard Deviation 3.803 |
| RA Participants (Biologic Exposed Group) | Mean Dosing Interval at Month 6 | 32.10 days | Standard Deviation 3.783 |
| RA Participants (Monotherapy Group) | Mean Dosing Interval at Month 6 | 29.63 days | Standard Deviation 1.505 |
| RA Participants (Combination Therapy Group) | Mean Dosing Interval at Month 6 | 31.48 days | Standard Deviation 3.978 |
| RA Participants (All Groups) | Mean Dosing Interval at Month 6 | 31.22 days | Standard Deviation 3.775 |
Secondary
Median Dose at Month 6
Time frame: Month 6
Population: FAS population. Here Number of participants analyzed = participants evaluable for the outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| RA Participants (Biologic Naïve Group) | Median Dose at Month 6 | 8 milligram per kilogram (mg/kg) |
| RA Participants (Biologic Exposed Group) | Median Dose at Month 6 | 8 milligram per kilogram (mg/kg) |
| RA Participants (Monotherapy Group) | Median Dose at Month 6 | 8 milligram per kilogram (mg/kg) |
| RA Participants (Combination Therapy Group) | Median Dose at Month 6 | 8 milligram per kilogram (mg/kg) |
| RA Participants (All Groups) | Median Dose at Month 6 | 8 milligram per kilogram (mg/kg) |
Secondary
Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6
Clinical response was assessed according to EULAR criteria that classified the participant according to individual changes in DAS28 score as good, moderate, or no response. The DAS28 score is a measurement of RA activity on a 0 to 10 scale, with higher scores represent higher disease activity, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient's global assessment of disease activity, which was measured on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly. Good responders experienced a change from baseline of greater than 1.2 with a DAS28 score less than or equal to 3.2.
Time frame: Month 3 and Month 6
Population: FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with EULAR response available at specified visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RA Participants (Biologic Naïve Group) | Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6 | Month 3 (n= 11, 3, 1, 13, 14) | 63.6 percentage of participants |
| RA Participants (Biologic Naïve Group) | Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6 | Month 6 (n= 10, 1,1, 10, 11) | 50.0 percentage of participants |
| RA Participants (Biologic Exposed Group) | Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6 | Month 3 (n= 11, 3, 1, 13, 14) | 66.7 percentage of participants |
| RA Participants (Biologic Exposed Group) | Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6 | Month 6 (n= 10, 1,1, 10, 11) | 100 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6 | Month 3 (n= 11, 3, 1, 13, 14) | 0 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6 | Month 6 (n= 10, 1,1, 10, 11) | 0 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6 | Month 6 (n= 10, 1,1, 10, 11) | 60.0 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6 | Month 3 (n= 11, 3, 1, 13, 14) | 69.2 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6 | Month 3 (n= 11, 3, 1, 13, 14) | 64.3 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6 | Month 6 (n= 10, 1,1, 10, 11) | 54.5 percentage of participants |
Secondary
Percentage of Participants Adhering to Local Label for Adverse Events
Percentage of participants who adhered to local label/protocol for the management of adverse events is reported.
Time frame: Baseline up to Month 6
Population: FAS population. Number of participants analyzed = participants with available data for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RA Participants (Biologic Naïve Group) | Percentage of Participants Adhering to Local Label for Adverse Events | 100 percentage of participants |
| RA Participants (Biologic Exposed Group) | Percentage of Participants Adhering to Local Label for Adverse Events | 100 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants Adhering to Local Label for Adverse Events | 100 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants Adhering to Local Label for Adverse Events | 75 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants Adhering to Local Label for Adverse Events | 80 percentage of participants |
Secondary
Percentage of Participants by Duration of Morning Stiffness
Duration of morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS by 1 of the six categories: less than (\<) 30 minutes, between 30 and 240 minutes, greater than (\>) 240 minutes and whole day.
Time frame: Baseline, Month 3, Month 6
Population: FAS population. Here, n= participants with available data at specified visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RA Participants (Biologic Naïve Group) | Percentage of Participants by Duration of Morning Stiffness | Month 3 (60-120 minutes) (n= 13, 4, 3, 14, 17) | 7.7 percentage of participants |
| RA Participants (Biologic Naïve Group) | Percentage of Participants by Duration of Morning Stiffness | Baseline (60-120 minutes) (n= 22, 6, 2, 26, 28) | 18.2 percentage of participants |
| RA Participants (Biologic Naïve Group) | Percentage of Participants by Duration of Morning Stiffness | Month 3 (30-60 minutes) (n= 13, 4, 3, 14, 17) | 53.8 percentage of participants |
| RA Participants (Biologic Naïve Group) | Percentage of Participants by Duration of Morning Stiffness | Baseline (whole day) (n= 22, 6, 2, 26, 28) | 9.1 percentage of participants |
| RA Participants (Biologic Naïve Group) | Percentage of Participants by Duration of Morning Stiffness | Month 6 (30-60 minutes) (n= 12, 3, 3, 12, 15) | 16.7 percentage of participants |
| RA Participants (Biologic Naïve Group) | Percentage of Participants by Duration of Morning Stiffness | Month 3 (< 30 minutes) (n=13, 4, 3, 14, 17) | 30.8 percentage of participants |
| RA Participants (Biologic Naïve Group) | Percentage of Participants by Duration of Morning Stiffness | Month 6 (whole day) (n= 12, 3, 3, 12, 15) | 8.3 percentage of participants |
| RA Participants (Biologic Naïve Group) | Percentage of Participants by Duration of Morning Stiffness | Month 6 (> 240 minutes) (n= 12, 3, 3, 12, 15) | 8.3 percentage of participants |
| RA Participants (Biologic Naïve Group) | Percentage of Participants by Duration of Morning Stiffness | Month 3 (> 240 minutes) (n= 13, 4, 3, 14, 17) | 0 percentage of participants |
| RA Participants (Biologic Naïve Group) | Percentage of Participants by Duration of Morning Stiffness | Baseline (> 240 minutes) (n= 22, 6, 2, 26, 28) | 22.7 percentage of participants |
| RA Participants (Biologic Naïve Group) | Percentage of Participants by Duration of Morning Stiffness | Month 6 (< 30 minutes) (n= 12, 3, 3, 12, 15) | 33.3 percentage of participants |
| RA Participants (Biologic Naïve Group) | Percentage of Participants by Duration of Morning Stiffness | Baseline ( < 30 minutes) (n= 22, 6, 2, 26, 28) | 4.5 percentage of participants |
| RA Participants (Biologic Naïve Group) | Percentage of Participants by Duration of Morning Stiffness | Month 6 (120-240 minutes) (n=12, 3, 3, 12, 15) | 25.0 percentage of participants |
| RA Participants (Biologic Naïve Group) | Percentage of Participants by Duration of Morning Stiffness | Month 3 (120-240 minutes) (n= 13, 4, 3, 14, 17) | 0 percentage of participants |
| RA Participants (Biologic Naïve Group) | Percentage of Participants by Duration of Morning Stiffness | Baseline (120-240 minutes) (n= 22, 6, 2, 26, 28) | 31.8 percentage of participants |
| RA Participants (Biologic Naïve Group) | Percentage of Participants by Duration of Morning Stiffness | Baseline (30-60 minutes) (n= 22, 6, 2, 26, 28) | 13.6 percentage of participants |
| RA Participants (Biologic Naïve Group) | Percentage of Participants by Duration of Morning Stiffness | Month 3 (whole day) (n= 13, 4, 3, 14, 17) | 7.7 percentage of participants |
| RA Participants (Biologic Naïve Group) | Percentage of Participants by Duration of Morning Stiffness | Month 6 (60-120 minutes) (n= 12, 3, 3, 12, 15) | 8.3 percentage of participants |
| RA Participants (Biologic Exposed Group) | Percentage of Participants by Duration of Morning Stiffness | Month 6 (< 30 minutes) (n= 12, 3, 3, 12, 15) | 0 percentage of participants |
| RA Participants (Biologic Exposed Group) | Percentage of Participants by Duration of Morning Stiffness | Baseline ( < 30 minutes) (n= 22, 6, 2, 26, 28) | 16.7 percentage of participants |
| RA Participants (Biologic Exposed Group) | Percentage of Participants by Duration of Morning Stiffness | Month 3 (< 30 minutes) (n=13, 4, 3, 14, 17) | 75.0 percentage of participants |
| RA Participants (Biologic Exposed Group) | Percentage of Participants by Duration of Morning Stiffness | Baseline (30-60 minutes) (n= 22, 6, 2, 26, 28) | 16.7 percentage of participants |
| RA Participants (Biologic Exposed Group) | Percentage of Participants by Duration of Morning Stiffness | Month 3 (30-60 minutes) (n= 13, 4, 3, 14, 17) | 0 percentage of participants |
| RA Participants (Biologic Exposed Group) | Percentage of Participants by Duration of Morning Stiffness | Month 6 (30-60 minutes) (n= 12, 3, 3, 12, 15) | 66.7 percentage of participants |
| RA Participants (Biologic Exposed Group) | Percentage of Participants by Duration of Morning Stiffness | Baseline (60-120 minutes) (n= 22, 6, 2, 26, 28) | 16.7 percentage of participants |
| RA Participants (Biologic Exposed Group) | Percentage of Participants by Duration of Morning Stiffness | Month 3 (60-120 minutes) (n= 13, 4, 3, 14, 17) | 25.0 percentage of participants |
| RA Participants (Biologic Exposed Group) | Percentage of Participants by Duration of Morning Stiffness | Month 6 (60-120 minutes) (n= 12, 3, 3, 12, 15) | 0 percentage of participants |
| RA Participants (Biologic Exposed Group) | Percentage of Participants by Duration of Morning Stiffness | Baseline (120-240 minutes) (n= 22, 6, 2, 26, 28) | 33.3 percentage of participants |
| RA Participants (Biologic Exposed Group) | Percentage of Participants by Duration of Morning Stiffness | Month 3 (120-240 minutes) (n= 13, 4, 3, 14, 17) | 0 percentage of participants |
| RA Participants (Biologic Exposed Group) | Percentage of Participants by Duration of Morning Stiffness | Month 6 (120-240 minutes) (n=12, 3, 3, 12, 15) | 0 percentage of participants |
| RA Participants (Biologic Exposed Group) | Percentage of Participants by Duration of Morning Stiffness | Baseline (> 240 minutes) (n= 22, 6, 2, 26, 28) | 16.7 percentage of participants |
| RA Participants (Biologic Exposed Group) | Percentage of Participants by Duration of Morning Stiffness | Month 3 (> 240 minutes) (n= 13, 4, 3, 14, 17) | 0 percentage of participants |
| RA Participants (Biologic Exposed Group) | Percentage of Participants by Duration of Morning Stiffness | Month 6 (> 240 minutes) (n= 12, 3, 3, 12, 15) | 33.3 percentage of participants |
| RA Participants (Biologic Exposed Group) | Percentage of Participants by Duration of Morning Stiffness | Baseline (whole day) (n= 22, 6, 2, 26, 28) | 0 percentage of participants |
| RA Participants (Biologic Exposed Group) | Percentage of Participants by Duration of Morning Stiffness | Month 3 (whole day) (n= 13, 4, 3, 14, 17) | 0 percentage of participants |
| RA Participants (Biologic Exposed Group) | Percentage of Participants by Duration of Morning Stiffness | Month 6 (whole day) (n= 12, 3, 3, 12, 15) | 0 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants by Duration of Morning Stiffness | Month 6 (whole day) (n= 12, 3, 3, 12, 15) | 0 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants by Duration of Morning Stiffness | Month 6 (< 30 minutes) (n= 12, 3, 3, 12, 15) | 0 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants by Duration of Morning Stiffness | Month 6 (30-60 minutes) (n= 12, 3, 3, 12, 15) | 66.7 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants by Duration of Morning Stiffness | Month 6 (120-240 minutes) (n=12, 3, 3, 12, 15) | 0 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants by Duration of Morning Stiffness | Baseline (whole day) (n= 22, 6, 2, 26, 28) | 0 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants by Duration of Morning Stiffness | Month 6 (> 240 minutes) (n= 12, 3, 3, 12, 15) | 33.3 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants by Duration of Morning Stiffness | Month 3 (< 30 minutes) (n=13, 4, 3, 14, 17) | 33.3 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants by Duration of Morning Stiffness | Month 3 (> 240 minutes) (n= 13, 4, 3, 14, 17) | 0 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants by Duration of Morning Stiffness | Baseline (> 240 minutes) (n= 22, 6, 2, 26, 28) | 50.0 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants by Duration of Morning Stiffness | Baseline (30-60 minutes) (n= 22, 6, 2, 26, 28) | 0 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants by Duration of Morning Stiffness | Baseline ( < 30 minutes) (n= 22, 6, 2, 26, 28) | 0 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants by Duration of Morning Stiffness | Baseline (120-240 minutes) (n= 22, 6, 2, 26, 28) | 0 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants by Duration of Morning Stiffness | Month 3 (60-120 minutes) (n= 13, 4, 3, 14, 17) | 33.3 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants by Duration of Morning Stiffness | Month 3 (30-60 minutes) (n= 13, 4, 3, 14, 17) | 33.3 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants by Duration of Morning Stiffness | Month 6 (60-120 minutes) (n= 12, 3, 3, 12, 15) | 0 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants by Duration of Morning Stiffness | Month 3 (whole day) (n= 13, 4, 3, 14, 17) | 0 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants by Duration of Morning Stiffness | Month 3 (120-240 minutes) (n= 13, 4, 3, 14, 17) | 0 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants by Duration of Morning Stiffness | Baseline (60-120 minutes) (n= 22, 6, 2, 26, 28) | 50.0 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants by Duration of Morning Stiffness | Month 3 (30-60 minutes) (n= 13, 4, 3, 14, 17) | 42.9 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants by Duration of Morning Stiffness | Month 3 (60-120 minutes) (n= 13, 4, 3, 14, 17) | 7.1 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants by Duration of Morning Stiffness | Baseline ( < 30 minutes) (n= 22, 6, 2, 26, 28) | 7.7 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants by Duration of Morning Stiffness | Month 6 (60-120 minutes) (n= 12, 3, 3, 12, 15) | 8.3 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants by Duration of Morning Stiffness | Month 6 (whole day) (n= 12, 3, 3, 12, 15) | 8.3 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants by Duration of Morning Stiffness | Baseline (120-240 minutes) (n= 22, 6, 2, 26, 28) | 34.6 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants by Duration of Morning Stiffness | Month 6 (< 30 minutes) (n= 12, 3, 3, 12, 15) | 33.3 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants by Duration of Morning Stiffness | Month 3 (120-240 minutes) (n= 13, 4, 3, 14, 17) | 0 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants by Duration of Morning Stiffness | Month 3 (whole day) (n= 13, 4, 3, 14, 17) | 7.1 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants by Duration of Morning Stiffness | Month 6 (120-240 minutes) (n=12, 3, 3, 12, 15) | 25.0 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants by Duration of Morning Stiffness | Baseline (> 240 minutes) (n= 22, 6, 2, 26, 28) | 19.2 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants by Duration of Morning Stiffness | Month 3 (< 30 minutes) (n=13, 4, 3, 14, 17) | 42.9 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants by Duration of Morning Stiffness | Month 3 (> 240 minutes) (n= 13, 4, 3, 14, 17) | 0 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants by Duration of Morning Stiffness | Month 6 (> 240 minutes) (n= 12, 3, 3, 12, 15) | 8.3 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants by Duration of Morning Stiffness | Month 6 (30-60 minutes) (n= 12, 3, 3, 12, 15) | 16.7 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants by Duration of Morning Stiffness | Baseline (whole day) (n= 22, 6, 2, 26, 28) | 7.7 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants by Duration of Morning Stiffness | Baseline (60-120 minutes) (n= 22, 6, 2, 26, 28) | 15.4 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants by Duration of Morning Stiffness | Baseline (30-60 minutes) (n= 22, 6, 2, 26, 28) | 15.4 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants by Duration of Morning Stiffness | Month 6 (120-240 minutes) (n=12, 3, 3, 12, 15) | 20.0 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants by Duration of Morning Stiffness | Baseline (60-120 minutes) (n= 22, 6, 2, 26, 28) | 17.9 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants by Duration of Morning Stiffness | Month 6 (> 240 minutes) (n= 12, 3, 3, 12, 15) | 13.3 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants by Duration of Morning Stiffness | Baseline ( < 30 minutes) (n= 22, 6, 2, 26, 28) | 7.1 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants by Duration of Morning Stiffness | Month 3 (120-240 minutes) (n= 13, 4, 3, 14, 17) | 0 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants by Duration of Morning Stiffness | Baseline (whole day) (n= 22, 6, 2, 26, 28) | 7.1 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants by Duration of Morning Stiffness | Month 3 (30-60 minutes) (n= 13, 4, 3, 14, 17) | 41.2 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants by Duration of Morning Stiffness | Baseline (120-240 minutes) (n= 22, 6, 2, 26, 28) | 32.1 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants by Duration of Morning Stiffness | Month 6 (< 30 minutes) (n= 12, 3, 3, 12, 15) | 26.7 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants by Duration of Morning Stiffness | Month 6 (60-120 minutes) (n= 12, 3, 3, 12, 15) | 6.7 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants by Duration of Morning Stiffness | Month 3 (60-120 minutes) (n= 13, 4, 3, 14, 17) | 11.8 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants by Duration of Morning Stiffness | Month 6 (30-60 minutes) (n= 12, 3, 3, 12, 15) | 26.7 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants by Duration of Morning Stiffness | Baseline (> 240 minutes) (n= 22, 6, 2, 26, 28) | 21.4 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants by Duration of Morning Stiffness | Month 3 (whole day) (n= 13, 4, 3, 14, 17) | 5.9 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants by Duration of Morning Stiffness | Baseline (30-60 minutes) (n= 22, 6, 2, 26, 28) | 14.3 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants by Duration of Morning Stiffness | Month 3 (> 240 minutes) (n= 13, 4, 3, 14, 17) | 0 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants by Duration of Morning Stiffness | Month 3 (< 30 minutes) (n=13, 4, 3, 14, 17) | 41.2 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants by Duration of Morning Stiffness | Month 6 (whole day) (n= 12, 3, 3, 12, 15) | 6.7 percentage of participants |
Secondary
Percentage of Participants by Reason for Choice of Monotherapy at Baseline
Time frame: Baseline up to Month 6
Population: Analysis was not performed as the data was not collected on case report form.
Secondary
Percentage of Participants on Tocilizumab Monotherapy (8 mg/Kg) at Baseline and at Month 6
Time frame: Baseline, Month 6
Population: FAS population. n= participants with available data at the specified visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RA Participants (Biologic Naïve Group) | Percentage of Participants on Tocilizumab Monotherapy (8 mg/Kg) at Baseline and at Month 6 | Baseline (n=29,8,5,32,37) | 93.1 percentage of participants |
| RA Participants (Biologic Naïve Group) | Percentage of Participants on Tocilizumab Monotherapy (8 mg/Kg) at Baseline and at Month 6 | Month 6 (n=20,8,4,24,28) | 87.0 percentage of participants |
| RA Participants (Biologic Exposed Group) | Percentage of Participants on Tocilizumab Monotherapy (8 mg/Kg) at Baseline and at Month 6 | Month 6 (n=20,8,4,24,28) | 100 percentage of participants |
| RA Participants (Biologic Exposed Group) | Percentage of Participants on Tocilizumab Monotherapy (8 mg/Kg) at Baseline and at Month 6 | Baseline (n=29,8,5,32,37) | 100 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants on Tocilizumab Monotherapy (8 mg/Kg) at Baseline and at Month 6 | Month 6 (n=20,8,4,24,28) | 100.0 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants on Tocilizumab Monotherapy (8 mg/Kg) at Baseline and at Month 6 | Baseline (n=29,8,5,32,37) | 100.0 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants on Tocilizumab Monotherapy (8 mg/Kg) at Baseline and at Month 6 | Month 6 (n=20,8,4,24,28) | 88.9 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants on Tocilizumab Monotherapy (8 mg/Kg) at Baseline and at Month 6 | Baseline (n=29,8,5,32,37) | 93.8 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants on Tocilizumab Monotherapy (8 mg/Kg) at Baseline and at Month 6 | Month 6 (n=20,8,4,24,28) | 90.3 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants on Tocilizumab Monotherapy (8 mg/Kg) at Baseline and at Month 6 | Baseline (n=29,8,5,32,37) | 94.6 percentage of participants |
Secondary
Percentage of Participants Starting Tocilizumab After Stopping a Biologic Treatment or After Failing DMARDs
Time frame: Baseline
Population: FAS population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RA Participants (Biologic Naïve Group) | Percentage of Participants Starting Tocilizumab After Stopping a Biologic Treatment or After Failing DMARDs | Previous biologic therapy | 0 percentage of participants |
| RA Participants (Biologic Naïve Group) | Percentage of Participants Starting Tocilizumab After Stopping a Biologic Treatment or After Failing DMARDs | Previous DMARD therapy | 31.0 percentage of participants |
| RA Participants (Biologic Exposed Group) | Percentage of Participants Starting Tocilizumab After Stopping a Biologic Treatment or After Failing DMARDs | Previous biologic therapy | 100 percentage of participants |
| RA Participants (Biologic Exposed Group) | Percentage of Participants Starting Tocilizumab After Stopping a Biologic Treatment or After Failing DMARDs | Previous DMARD therapy | 7.5 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants Starting Tocilizumab After Stopping a Biologic Treatment or After Failing DMARDs | Previous biologic therapy | 40 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants Starting Tocilizumab After Stopping a Biologic Treatment or After Failing DMARDs | Previous DMARD therapy | 100 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants Starting Tocilizumab After Stopping a Biologic Treatment or After Failing DMARDs | Previous DMARD therapy | 34.4 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants Starting Tocilizumab After Stopping a Biologic Treatment or After Failing DMARDs | Previous biologic therapy | 18.8 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants Starting Tocilizumab After Stopping a Biologic Treatment or After Failing DMARDs | Previous biologic therapy | 21.6 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants Starting Tocilizumab After Stopping a Biologic Treatment or After Failing DMARDs | Previous DMARD therapy | 43.2 percentage of participants |
Secondary
Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment
ACR 20,50 or 70 response=an improvement of ≥ 20%, ≥ 50% or ≥ 70% respectively, as compared to baseline in TJC28 and SJC28, and 20%, 50% or 70% improvement in at least 3 of the 5 following measures: Patient's Assessment of Pain over the previous 24 hours, PGA, PhGA, HAQ, and acute phase reactant (either CRP or ESR). TJC and SJC, based on 28-joint assessments. Number of tender joints and swollen joints were recorded on the joint assessment form at baseline, no tenderness = 0 and tenderness = 1, no swelling = 0 and swelling =1, respectively. HAQ measures functional status (disability) and health-related quality of life with 20 questions, summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week, 0=without difficulty to 3=unable to do. Patient's assessment of pain assessed using a VAS; 0=no pain, 100=unbearable pain; PGA and PhGA, assessed using VAS ; 0= no disease activity, 100=maximum disease activity.
Time frame: Month 3 and Month 6
Population: FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data for the specified visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RA Participants (Biologic Naïve Group) | Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment | Month 3: ACR20 responders (n= 11, 3, 2, 12, 14) | 90.9 percentage of participants |
| RA Participants (Biologic Naïve Group) | Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment | Month 6: ACR20 responders (n= 10, 1, 2, 9, 11) | 80.0 percentage of participants |
| RA Participants (Biologic Naïve Group) | Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment | Month 3: ACR50 responders (n= 11, 3, 2, 12, 14) | 63.6 percentage of participants |
| RA Participants (Biologic Naïve Group) | Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment | Month 6: ACR50 responders (n= 10, 1, 2, 9, 11) | 70.0 percentage of participants |
| RA Participants (Biologic Naïve Group) | Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment | Month 3: ACR70 responders (n= 11, 3, 2, 12, 14) | 36.4 percentage of participants |
| RA Participants (Biologic Naïve Group) | Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment | Month 6: ACR70 responders (n= 10, 1, 2, 9, 11) | 50.0 percentage of participants |
| RA Participants (Biologic Exposed Group) | Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment | Month 3: ACR70 responders (n= 11, 3, 2, 12, 14) | 0.0 percentage of participants |
| RA Participants (Biologic Exposed Group) | Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment | Month 6: ACR70 responders (n= 10, 1, 2, 9, 11) | 0.0 percentage of participants |
| RA Participants (Biologic Exposed Group) | Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment | Month 3: ACR20 responders (n= 11, 3, 2, 12, 14) | 100.0 percentage of participants |
| RA Participants (Biologic Exposed Group) | Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment | Month 3: ACR50 responders (n= 11, 3, 2, 12, 14) | 33.3 percentage of participants |
| RA Participants (Biologic Exposed Group) | Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment | Month 6: ACR50 responders (n= 10, 1, 2, 9, 11) | 0.0 percentage of participants |
| RA Participants (Biologic Exposed Group) | Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment | Month 6: ACR20 responders (n= 10, 1, 2, 9, 11) | 100.0 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment | Month 6: ACR50 responders (n= 10, 1, 2, 9, 11) | 50.0 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment | Month 3: ACR70 responders (n= 11, 3, 2, 12, 14) | 0.0 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment | Month 3: ACR20 responders (n= 11, 3, 2, 12, 14) | 100.0 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment | Month 3: ACR50 responders (n= 11, 3, 2, 12, 14) | 0.0 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment | Month 6: ACR20 responders (n= 10, 1, 2, 9, 11) | 100.0 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment | Month 6: ACR70 responders (n= 10, 1, 2, 9, 11) | 0.0 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment | Month 6: ACR50 responders (n= 10, 1, 2, 9, 11) | 66.7 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment | Month 6: ACR20 responders (n= 10, 1, 2, 9, 11) | 77.8 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment | Month 3: ACR50 responders (n= 11, 3, 2, 12, 14) | 66.7 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment | Month 6: ACR70 responders (n= 10, 1, 2, 9, 11) | 55.6 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment | Month 3: ACR70 responders (n= 11, 3, 2, 12, 14) | 33.3 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment | Month 3: ACR20 responders (n= 11, 3, 2, 12, 14) | 91.7 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment | Month 3: ACR70 responders (n= 11, 3, 2, 12, 14) | 28.6 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment | Month 3: ACR50 responders (n= 11, 3, 2, 12, 14) | 57.1 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment | Month 6: ACR20 responders (n= 10, 1, 2, 9, 11) | 81.8 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment | Month 6: ACR70 responders (n= 10, 1, 2, 9, 11) | 45.5 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment | Month 6: ACR50 responders (n= 10, 1, 2, 9, 11) | 63.6 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment | Month 3: ACR20 responders (n= 11, 3, 2, 12, 14) | 92.9 percentage of participants |
Secondary
Percentage of Participants With and Without Morning Stiffness
Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant assessed morning stiffness based on the following criteria: 1. Presence of participant's joints stiff when woke up that day, measured as yes or no 2. Duration of morning stiffness, measured using a ruler on a 100 mm VAS by 1 of the six categories: \< 30 minutes, between 30 and 240 minutes, \> 240 minutes, and the whole day. 3. Severity of morning stiffness measured using a ruler on a 100 mm VAS where the responses were on a continuous range from 0 = no stiffness to 100 = maximum stiffness.
Time frame: Baseline, Month 3, Month 6
Population: FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with available data at the specified visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RA Participants (Biologic Naïve Group) | Percentage of Participants With and Without Morning Stiffness | Baseline(with morning stiffness)(n=24,6,3,27,30) | 95.8 percentage of participants |
| RA Participants (Biologic Naïve Group) | Percentage of Participants With and Without Morning Stiffness | Baseline(without morningstiffness)(n=24,6,3,27,30) | 4.2 percentage of participants |
| RA Participants (Biologic Naïve Group) | Percentage of Participants With and Without Morning Stiffness | Month 3(with morning stiffness)(n=14,5,4,15,19) | 92.9 percentage of participants |
| RA Participants (Biologic Naïve Group) | Percentage of Participants With and Without Morning Stiffness | Month 3(without morning stiffness)(n=14,5,4,15,19) | 7.1 percentage of participants |
| RA Participants (Biologic Naïve Group) | Percentage of Participants With and Without Morning Stiffness | Month 6(with morning stiffness)(n=14,3,4,13,17) | 92.9 percentage of participants |
| RA Participants (Biologic Naïve Group) | Percentage of Participants With and Without Morning Stiffness | Month 6(without morning stiffness)(n=14,3,4,13,17) | 17.1 percentage of participants |
| RA Participants (Biologic Exposed Group) | Percentage of Participants With and Without Morning Stiffness | Month 6(with morning stiffness)(n=14,3,4,13,17) | 100 percentage of participants |
| RA Participants (Biologic Exposed Group) | Percentage of Participants With and Without Morning Stiffness | Month 6(without morning stiffness)(n=14,3,4,13,17) | 0 percentage of participants |
| RA Participants (Biologic Exposed Group) | Percentage of Participants With and Without Morning Stiffness | Baseline(with morning stiffness)(n=24,6,3,27,30) | 100 percentage of participants |
| RA Participants (Biologic Exposed Group) | Percentage of Participants With and Without Morning Stiffness | Month 3(with morning stiffness)(n=14,5,4,15,19) | 100 percentage of participants |
| RA Participants (Biologic Exposed Group) | Percentage of Participants With and Without Morning Stiffness | Month 3(without morning stiffness)(n=14,5,4,15,19) | 0 percentage of participants |
| RA Participants (Biologic Exposed Group) | Percentage of Participants With and Without Morning Stiffness | Baseline(without morningstiffness)(n=24,6,3,27,30) | 0 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants With and Without Morning Stiffness | Month 3(without morning stiffness)(n=14,5,4,15,19) | 0 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants With and Without Morning Stiffness | Month 6(with morning stiffness)(n=14,3,4,13,17) | 100 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants With and Without Morning Stiffness | Baseline(with morning stiffness)(n=24,6,3,27,30) | 100 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants With and Without Morning Stiffness | Month 3(with morning stiffness)(n=14,5,4,15,19) | 100 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants With and Without Morning Stiffness | Baseline(without morningstiffness)(n=24,6,3,27,30) | 0 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants With and Without Morning Stiffness | Month 6(without morning stiffness)(n=14,3,4,13,17) | 0 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants With and Without Morning Stiffness | Month 3(without morning stiffness)(n=14,5,4,15,19) | 6.7 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants With and Without Morning Stiffness | Baseline(without morningstiffness)(n=24,6,3,27,30) | 3.7 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants With and Without Morning Stiffness | Month 3(with morning stiffness)(n=14,5,4,15,19) | 93.3 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants With and Without Morning Stiffness | Month 6(without morning stiffness)(n=14,3,4,13,17) | 7.7 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants With and Without Morning Stiffness | Month 6(with morning stiffness)(n=14,3,4,13,17) | 92.3 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants With and Without Morning Stiffness | Baseline(with morning stiffness)(n=24,6,3,27,30) | 96.3 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants With and Without Morning Stiffness | Month 6(with morning stiffness)(n=14,3,4,13,17) | 94.1 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants With and Without Morning Stiffness | Month 3(with morning stiffness)(n=14,5,4,15,19) | 94.7 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants With and Without Morning Stiffness | Baseline(without morningstiffness)(n=24,6,3,27,30) | 3.3 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants With and Without Morning Stiffness | Month 6(without morning stiffness)(n=14,3,4,13,17) | 5.9 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants With and Without Morning Stiffness | Month 3(without morning stiffness)(n=14,5,4,15,19) | 5.3 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants With and Without Morning Stiffness | Baseline(with morning stiffness)(n=24,6,3,27,30) | 96.7 percentage of participants |
Secondary
Percentage of Participants With Reasons Who Discontinued Tocilizumab
Time frame: Baseline up to Month 6
Population: FAS population. Here, Number of Participants Analyzed (N) signifies participants who discontinued tocilizumab treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RA Participants (Biologic Naïve Group) | Percentage of Participants With Reasons Who Discontinued Tocilizumab | Lack of efficacy | 20.0 percentage of participants |
| RA Participants (Biologic Naïve Group) | Percentage of Participants With Reasons Who Discontinued Tocilizumab | Unspecified | 40.0 percentage of participants |
| RA Participants (Biologic Naïve Group) | Percentage of Participants With Reasons Who Discontinued Tocilizumab | Adverse event | 40.0 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants With Reasons Who Discontinued Tocilizumab | Lack of efficacy | 0 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants With Reasons Who Discontinued Tocilizumab | Unspecified | 100.0 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants With Reasons Who Discontinued Tocilizumab | Adverse event | 0 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants With Reasons Who Discontinued Tocilizumab | Adverse event | 50.0 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants With Reasons Who Discontinued Tocilizumab | Lack of efficacy | 25.0 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants With Reasons Who Discontinued Tocilizumab | Unspecified | 25.0 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants With Reasons Who Discontinued Tocilizumab | Lack of efficacy | 20.0 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants With Reasons Who Discontinued Tocilizumab | Unspecified | 40.0 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants With Reasons Who Discontinued Tocilizumab | Adverse event | 40.0 percentage of participants |
Secondary
Percentage of Participants With Tocilizumab Dose Changed According to the Reason for Change
Percentage of participants with increase or decrease in tocilizumab administration according to the reason for dose modification was reported.
Time frame: Baseline up to Month 6
Population: FAS population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RA Participants (Biologic Naïve Group) | Percentage of Participants With Tocilizumab Dose Changed According to the Reason for Change | Increase in dose | 0 percentage of participants |
| RA Participants (Biologic Naïve Group) | Percentage of Participants With Tocilizumab Dose Changed According to the Reason for Change | Reason:Unspecified | 3.4 percentage of participants |
| RA Participants (Biologic Naïve Group) | Percentage of Participants With Tocilizumab Dose Changed According to the Reason for Change | Decrease in dose | 3.4 percentage of participants |
| RA Participants (Biologic Exposed Group) | Percentage of Participants With Tocilizumab Dose Changed According to the Reason for Change | Decrease in dose | 0 percentage of participants |
| RA Participants (Biologic Exposed Group) | Percentage of Participants With Tocilizumab Dose Changed According to the Reason for Change | Increase in dose | 12.5 percentage of participants |
| RA Participants (Biologic Exposed Group) | Percentage of Participants With Tocilizumab Dose Changed According to the Reason for Change | Reason:Unspecified | 12.5 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants With Tocilizumab Dose Changed According to the Reason for Change | Decrease in dose | 0 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants With Tocilizumab Dose Changed According to the Reason for Change | Increase in dose | 0 percentage of participants |
| RA Participants (Monotherapy Group) | Percentage of Participants With Tocilizumab Dose Changed According to the Reason for Change | Reason:Unspecified | 0 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants With Tocilizumab Dose Changed According to the Reason for Change | Increase in dose | 3.1 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants With Tocilizumab Dose Changed According to the Reason for Change | Reason:Unspecified | 6.3 percentage of participants |
| RA Participants (Combination Therapy Group) | Percentage of Participants With Tocilizumab Dose Changed According to the Reason for Change | Decrease in dose | 3.1 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants With Tocilizumab Dose Changed According to the Reason for Change | Decrease in dose | 2.7 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants With Tocilizumab Dose Changed According to the Reason for Change | Increase in dose | 2.7 percentage of participants |
| RA Participants (All Groups) | Percentage of Participants With Tocilizumab Dose Changed According to the Reason for Change | Reason:Unspecified | 5.4 percentage of participants |
Secondary
Simplified Disease Activity Index (SDAI) Score by Visit
The SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in centimeters) + PhGH (in centimeters) + CRP (in mg/dL), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 = no arthritis activity and 100 = extremely active arthritis, CRP = serum concentration of c-reactive protein; with a total SDAI score ranged from 0-86. Higher scores indicate greater disease activity. SDAI scores of less than or equal to 3.3 represents clinical remission, less than or equal to 11.0 represents low disease activity, less than or equal to 26.0 represents moderate disease activity, and greater than 26.0 represents high (or severe) disease.
Time frame: Baseline, Month 3, Month 6
Population: FAS population. Here, Number of participants analyzed = participants evaluable for the outcome measure and n= participants with SDAI score available at the specified visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RA Participants (Biologic Naïve Group) | Simplified Disease Activity Index (SDAI) Score by Visit | Baseline (n= 22, 6, 3, 25, 28) | 48.01 units on a scale | Standard Deviation 16.853 |
| RA Participants (Biologic Naïve Group) | Simplified Disease Activity Index (SDAI) Score by Visit | Month 6 (n= 12, 2, 2, 12, 14) | 14.55 units on a scale | Standard Deviation 15.357 |
| RA Participants (Biologic Naïve Group) | Simplified Disease Activity Index (SDAI) Score by Visit | Month 3 (n= 11, 4, 2, 13, 15) | 13.29 units on a scale | Standard Deviation 11.602 |
| RA Participants (Biologic Exposed Group) | Simplified Disease Activity Index (SDAI) Score by Visit | Month 3 (n= 11, 4, 2, 13, 15) | 15.16 units on a scale | Standard Deviation 6.066 |
| RA Participants (Biologic Exposed Group) | Simplified Disease Activity Index (SDAI) Score by Visit | Baseline (n= 22, 6, 3, 25, 28) | 43.57 units on a scale | Standard Deviation 14.898 |
| RA Participants (Biologic Exposed Group) | Simplified Disease Activity Index (SDAI) Score by Visit | Month 6 (n= 12, 2, 2, 12, 14) | 14.65 units on a scale | Standard Deviation 5.798 |
| RA Participants (Monotherapy Group) | Simplified Disease Activity Index (SDAI) Score by Visit | Month 3 (n= 11, 4, 2, 13, 15) | 14.95 units on a scale | Standard Deviation 3.536 |
| RA Participants (Monotherapy Group) | Simplified Disease Activity Index (SDAI) Score by Visit | Baseline (n= 22, 6, 3, 25, 28) | 47.07 units on a scale | Standard Deviation 6.689 |
| RA Participants (Monotherapy Group) | Simplified Disease Activity Index (SDAI) Score by Visit | Month 6 (n= 12, 2, 2, 12, 14) | 13.70 units on a scale | Standard Deviation 7.142 |
| RA Participants (Combination Therapy Group) | Simplified Disease Activity Index (SDAI) Score by Visit | Baseline (n= 22, 6, 3, 25, 28) | 47.06 units on a scale | Standard Deviation 17.173 |
| RA Participants (Combination Therapy Group) | Simplified Disease Activity Index (SDAI) Score by Visit | Month 6 (n= 12, 2, 2, 12, 14) | 14.70 units on a scale | Standard Deviation 15.301 |
| RA Participants (Combination Therapy Group) | Simplified Disease Activity Index (SDAI) Score by Visit | Month 3 (n= 11, 4, 2, 13, 15) | 13.61 units on a scale | Standard Deviation 10.997 |
| RA Participants (All Groups) | Simplified Disease Activity Index (SDAI) Score by Visit | Month 3 (n= 11, 4, 2, 13, 15) | 13.79 units on a scale | Standard Deviation 10.236 |
| RA Participants (All Groups) | Simplified Disease Activity Index (SDAI) Score by Visit | Baseline (n= 22, 6, 3, 25, 28) | 47.06 units on a scale | Standard Deviation 16.293 |
| RA Participants (All Groups) | Simplified Disease Activity Index (SDAI) Score by Visit | Month 6 (n= 12, 2, 2, 12, 14) | 14.56 units on a scale | Standard Deviation 14.218 |
Secondary
Time to Restoration of Initial Dosing Regimen
Time frame: Baseline up to Month 6
Population: Analysis was not performed due to inadequate data available for this outcome measure.