Rheumatoid Arthritis
Conditions
Brief summary
This prospective, multi-center, observational study will evaluate the efficacy and the safety of MabThera (rituximab) in participants with rheumatoid arthritis who have not responded or have been intolerant to a first anti-TNF alpha therapy. Participants have commenced MabThera or an alternative anti-TNF alpha treatment as a second biological therapy. Data will be collected for 12 months.
Interventions
DRUGRituximab
Rituximab as per physician's discretion.
DRUGAdalimumab
Adalimumab as per physician's discretion.
DRUGEtanercept
Etanercept as per physician's discretion.
DRUGInfliximab
Infliximab as per physician's discretion.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult participants, \>/=20 years of age * Participants with rheumatoid arthritis, who have not responded or have been intolerant to a single anti-TNF alpha therapy and who have initiated MabThera or an alternative anti-TNF alpha therapy
Exclusion criteria
* Participants whose first anti-TNF alpha treatment was, or second biological therapy is given as part of a clinical trial studying rheumatoid arthritis * Participants who have not signed the informed consent form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Intention to Treat (ITT) Population | Baseline and Month 6 | DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hr\]) and patient's global assessment of disease activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=\<) 3.2 = low disease activity, a DAS28 score of \>3.2 to 5.1 = moderate to high disease activity. |
| Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Standard Population Set (SPS) | Baseline and Month 6 | DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hr\]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=\<) 3.2 = low disease activity, a DAS28 score of \>3.2 to 5.1 = moderate to high disease activity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Standard Population Set (SPS) | Baseline, Month 6 and 12 | TJC is a clinical method to quantify abnormalities in participants with RA. It is associated with the level of pain. The number of tender joints were scored as tender=1 and not tender=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of tender joints). |
| Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Intention to Treat (ITT) Population | Baseline, Month 6 and 12 | SJC is a clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue. The number of swollen joints were scored as swollen=1 and not swollen=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of swollen joints). |
| Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Standard Population Set (SPS) | Baseline, Month 6 and 12 | SJC is a clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue. The number of swollen joints were scored as swollen=1 and not swollen=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of swollen joints). |
| Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Intention to Treat (ITT) Population | Baseline, Month 6 and 12 | ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline represents a reduction in inflammation. |
| Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Standard Population Set (SPS) | Baseline, Month 6 and 12 | ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline represents a reduction in inflammation. |
| Efficacy: Mean Change From Baseline in DAS28 at Month 12 | Baseline and Month 12 | DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hr\]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=\<) 3.2 = low disease activity, a DAS28 score of \>3.2 to 5.1 = moderate to high disease activity. |
| Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Standard Population Set (SPS) | Baseline, Month 6 and 12 | CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as RA. A negative change from baseline represents a reduction in inflammation. |
| Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Intention to Treat (ITT) Population | Month 6 | The HAQ-DI is a participant-completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do). The overall HAQ-DI score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. |
| Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Standard Population Set (SPS) | Month 6 | The HAQ-DI is a participant-completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do). The overall HAQ-DI score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. |
| Safety: Number of Participants With Adverse Events (AE), Adverse Drug Reactions (ADR) and Serious Adverse Events | Baseline up to Month 12 | An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant. |
| Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Intention to Treat (ITT) Population | Baseline, Month 6 and 12 | CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as RA. A negative change from baseline represents a reduction in inflammation. |
| Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Intention to Treat (ITT) Population | Baseline, Month 6 and 12 | TJC is a clinical method to quantify abnormalities in participants with RA. It is associated with the level of pain. The number of tender joints were scored as tender=1 and not tender=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of tender joints). |
Countries
South Korea
Participant flow
Pre-assignment details
The arm Other anti-TNF agent consisting of participants treated with adalimumab, etanercept and infliximab was divided into individual treatment groups only for the purpose of Participant flow reporting. All other analyses were performed in Rituximab versus Other anti-TNF agent.
Participants by arm
| Arm | Count |
|---|---|
| Rituximab Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months. | 34 |
| Other Anti-TNF Agent Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician's discretion for RA treatment were observed for 12 months. | 31 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Follow-up loss | 3 | 3 | 1 | 0 |
| Overall Study | Other | 1 | 1 | 2 | 1 |
| Overall Study | Withdrew consent | 2 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Rituximab | Other Anti-TNF Agent | Total |
|---|---|---|---|
| Age, Customized 20-29 years | 0 participants | 2 participants | 2 participants |
| Age, Customized 30-39 years | 4 participants | 4 participants | 8 participants |
| Age, Customized 40-49 years | 7 participants | 7 participants | 14 participants |
| Age, Customized 50-59 years | 6 participants | 7 participants | 13 participants |
| Age, Customized 60-69 years | 15 participants | 6 participants | 21 participants |
| Age, Customized 70-79 years | 2 participants | 5 participants | 7 participants |
| Sex: Female, Male Female | 25 Participants | 26 Participants | 51 Participants |
| Sex: Female, Male Male | 9 Participants | 5 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 34 | 2 / 31 |
| serious Total, serious adverse events | 3 / 34 | 0 / 31 |
Outcome results
Primary
Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Intention to Treat (ITT) Population
DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hr\]) and patient's global assessment of disease activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=\<) 3.2 = low disease activity, a DAS28 score of \>3.2 to 5.1 = moderate to high disease activity.
Time frame: Baseline and Month 6
Population: The ITT set included participants who offered end-point results among participants who received study drugs after enrollment and met all inclusion/exclusion criteria.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab | Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Intention to Treat (ITT) Population | Baseline | 6.35 units on a scale | Standard Deviation 1.14 |
| Rituximab | Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Intention to Treat (ITT) Population | Change at Month 6 | -1.89 units on a scale | Standard Deviation 1.73 |
| Other Anti-TNF Agent | Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Intention to Treat (ITT) Population | Baseline | 5.54 units on a scale | Standard Deviation 1.14 |
| Other Anti-TNF Agent | Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Intention to Treat (ITT) Population | Change at Month 6 | -1.80 units on a scale | Standard Deviation 1.53 |
p-value: 0.3037ANCOVA
Primary
Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Standard Population Set (SPS)
DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hr\]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=\<) 3.2 = low disease activity, a DAS28 score of \>3.2 to 5.1 = moderate to high disease activity.
Time frame: Baseline and Month 6
Population: The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab | Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Standard Population Set (SPS) | Baseline | 6.30 units on a scale | Standard Deviation 1.18 |
| Rituximab | Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Standard Population Set (SPS) | Change at Month 6 | -1.74 units on a scale | Standard Deviation 1.59 |
| Other Anti-TNF Agent | Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Standard Population Set (SPS) | Baseline | 5.47 units on a scale | Standard Deviation 1.04 |
| Other Anti-TNF Agent | Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Standard Population Set (SPS) | Change at Month 6 | -1.91 units on a scale | Standard Deviation 1.53 |
p-value: 0.0951ANCOVA
Secondary
Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Intention to Treat (ITT) Population
The HAQ-DI is a participant-completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do). The overall HAQ-DI score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.
Time frame: Month 6
Population: The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria. Here number of participants analyzed is the total participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rituximab | Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Intention to Treat (ITT) Population | 0.69 units on a scale | Standard Deviation 0.7 |
| Other Anti-TNF Agent | Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Intention to Treat (ITT) Population | 0.40 units on a scale | Standard Deviation 0.48 |
p-value: 0.0568ANCOVA
Secondary
Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Standard Population Set (SPS)
The HAQ-DI is a participant-completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do). The overall HAQ-DI score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.
Time frame: Month 6
Population: The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set. Here number of participants analyzed is the total participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rituximab | Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Standard Population Set (SPS) | 0.73 units on a scale | Standard Deviation 0.71 |
| Other Anti-TNF Agent | Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Standard Population Set (SPS) | 0.46 units on a scale | Standard Deviation 0.52 |
p-value: 0.1167ANCOVA
Secondary
Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Intention to Treat (ITT) Population
CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as RA. A negative change from baseline represents a reduction in inflammation.
Time frame: Baseline, Month 6 and 12
Population: The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria. Here, 'n' represents the participants who were evaluable at specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab | Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Intention to Treat (ITT) Population | Baseline (n=34, 31) | 3.53 milligram/deciliter (mg/dL) | Standard Deviation 3.07 |
| Rituximab | Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Intention to Treat (ITT) Population | Change at Month 6 (n=34, 30) | -1.84 milligram/deciliter (mg/dL) | Standard Deviation 3.43 |
| Rituximab | Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Intention to Treat (ITT) Population | Change at Month 12 (n=31, 25) | -0.69 milligram/deciliter (mg/dL) | Standard Deviation 6.56 |
| Other Anti-TNF Agent | Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Intention to Treat (ITT) Population | Change at Month 6 (n=34, 30) | -0.74 milligram/deciliter (mg/dL) | Standard Deviation 3.25 |
| Other Anti-TNF Agent | Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Intention to Treat (ITT) Population | Change at Month 12 (n=31, 25) | -1.51 milligram/deciliter (mg/dL) | Standard Deviation 2.61 |
| Other Anti-TNF Agent | Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Intention to Treat (ITT) Population | Baseline (n=34, 31) | 2.56 milligram/deciliter (mg/dL) | Standard Deviation 2.73 |
p-value: 0.49ANCOVA
p-value: 0.1826ANCOVA
Secondary
Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Standard Population Set (SPS)
CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as RA. A negative change from baseline represents a reduction in inflammation.
Time frame: Baseline, Month 6 and 12
Population: The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set. Here, 'n' represents the participants who were evaluable at specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab | Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Standard Population Set (SPS) | Baseline (n=31, 24) | 3.53 mg/dL | Standard Deviation 3.17 |
| Rituximab | Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Standard Population Set (SPS) | Change at Month 6 (n=31, 24) | -1.79 mg/dL | Standard Deviation 3.56 |
| Rituximab | Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Standard Population Set (SPS) | Change at Month 12 (n=28, 20) | -0.60 mg/dL | Standard Deviation 6.88 |
| Other Anti-TNF Agent | Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Standard Population Set (SPS) | Baseline (n=31, 24) | 2.59 mg/dL | Standard Deviation 2.78 |
| Other Anti-TNF Agent | Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Standard Population Set (SPS) | Change at Month 6 (n=31, 24) | -1.63 mg/dL | Standard Deviation 2.37 |
| Other Anti-TNF Agent | Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Standard Population Set (SPS) | Change at Month 12 (n=28, 20) | -1.59 mg/dL | Standard Deviation 2.73 |
p-value: 0.1894ANCOVA
p-value: 0.1805ANCOVA
Secondary
Efficacy: Mean Change From Baseline in DAS28 at Month 12
DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hr\]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=\<) 3.2 = low disease activity, a DAS28 score of \>3.2 to 5.1 = moderate to high disease activity.
Time frame: Baseline and Month 12
Population: Analysis was performed on participants who were administered with secondary biological agent continuously without change or suspension for 12 months. Here, 'n' represents the participants who were evaluable at specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab | Efficacy: Mean Change From Baseline in DAS28 at Month 12 | Baseline (n=24, 17) | 6.28 units on a scale | Standard Deviation 1.27 |
| Rituximab | Efficacy: Mean Change From Baseline in DAS28 at Month 12 | Change at Month 12 (n=22, 16) | -2.30 units on a scale | Standard Deviation 1.52 |
| Other Anti-TNF Agent | Efficacy: Mean Change From Baseline in DAS28 at Month 12 | Baseline (n=24, 17) | 5.49 units on a scale | Standard Deviation 0.92 |
| Other Anti-TNF Agent | Efficacy: Mean Change From Baseline in DAS28 at Month 12 | Change at Month 12 (n=22, 16) | -2.29 units on a scale | Standard Deviation 1.36 |
p-value: 0.239ANCOVA
Secondary
Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Intention to Treat (ITT) Population
ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline represents a reduction in inflammation.
Time frame: Baseline, Month 6 and 12
Population: The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria. Here, 'n' represents the participants who were evaluable at specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab | Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Intention to Treat (ITT) Population | Baseline (n=34, 31) | 67.00 millimeter/hour (mm/hr) | Standard Deviation 27.5 |
| Rituximab | Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Intention to Treat (ITT) Population | Change at Month 6 (n=34, 31) | -19.35 millimeter/hour (mm/hr) | Standard Deviation 27.03 |
| Rituximab | Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Intention to Treat (ITT) Population | Change at Month 12 (n=31, 25) | -20.36 millimeter/hour (mm/hr) | Standard Deviation 29.84 |
| Other Anti-TNF Agent | Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Intention to Treat (ITT) Population | Baseline (n=34, 31) | 60.77 millimeter/hour (mm/hr) | Standard Deviation 30.76 |
| Other Anti-TNF Agent | Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Intention to Treat (ITT) Population | Change at Month 6 (n=34, 31) | -15.55 millimeter/hour (mm/hr) | Standard Deviation 33.19 |
| Other Anti-TNF Agent | Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Intention to Treat (ITT) Population | Change at Month 12 (n=31, 25) | -21.64 millimeter/hour (mm/hr) | Standard Deviation 28.16 |
p-value: 0.8987ANCOVA
p-value: 0.5808ANCOVA
Secondary
Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Standard Population Set (SPS)
ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline represents a reduction in inflammation.
Time frame: Baseline, Month 6 and 12
Population: The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set. Here, 'n' represents the participants who were evaluable at specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab | Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Standard Population Set (SPS) | Baseline (n=31, 24) | 67.55 mm/hr | Standard Deviation 28.76 |
| Rituximab | Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Standard Population Set (SPS) | Change at Month 6 (n=31, 24) | -19.13 mm/hr | Standard Deviation 26.96 |
| Rituximab | Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Standard Population Set (SPS) | Change at Month 12 (n=28, 20) | -21.54 mm/hr | Standard Deviation 30.51 |
| Other Anti-TNF Agent | Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Standard Population Set (SPS) | Baseline (n=31, 24) | 61.58 mm/hr | Standard Deviation 29.47 |
| Other Anti-TNF Agent | Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Standard Population Set (SPS) | Change at Month 6 (n=31, 24) | -23.21 mm/hr | Standard Deviation 31.33 |
| Other Anti-TNF Agent | Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Standard Population Set (SPS) | Change at Month 12 (n=28, 20) | -22.10 mm/hr | Standard Deviation 26.11 |
p-value: 0.2282ANCOVA
p-value: 0.5849ANCOVA
Secondary
Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Intention to Treat (ITT) Population
SJC is a clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue. The number of swollen joints were scored as swollen=1 and not swollen=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of swollen joints).
Time frame: Baseline, Month 6 and 12
Population: The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria. Here, 'n' represents the participants who were evaluable at specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab | Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Intention to Treat (ITT) Population | Baseline (n=34, 31) | 11.24 number of swollen joints | Standard Deviation 6.78 |
| Rituximab | Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Intention to Treat (ITT) Population | Change at Month 6 (n=34, 31) | -7.00 number of swollen joints | Standard Deviation 6.86 |
| Rituximab | Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Intention to Treat (ITT) Population | Change at Month 12 (n-29, 24) | -8.62 number of swollen joints | Standard Deviation 6.52 |
| Other Anti-TNF Agent | Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Intention to Treat (ITT) Population | Baseline (n=34, 31) | 7.52 number of swollen joints | Standard Deviation 6.63 |
| Other Anti-TNF Agent | Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Intention to Treat (ITT) Population | Change at Month 6 (n=34, 31) | -5.10 number of swollen joints | Standard Deviation 6.48 |
| Other Anti-TNF Agent | Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Intention to Treat (ITT) Population | Change at Month 12 (n-29, 24) | -4.29 number of swollen joints | Standard Deviation 5.81 |
p-value: 0.5306ANCOVA
p-value: 0.2542ANCOVA
Secondary
Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Standard Population Set (SPS)
SJC is a clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue. The number of swollen joints were scored as swollen=1 and not swollen=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of swollen joints).
Time frame: Baseline, Month 6 and 12
Population: The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set. Here, 'n' represents the participants who were evaluable at specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab | Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Standard Population Set (SPS) | Baseline (n=31, 24) | 11.16 number of swollen joints | Standard Deviation 7.1 |
| Rituximab | Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Standard Population Set (SPS) | Change at Month 6 (n=31, 24) | -6.74 number of swollen joints | Standard Deviation 7.02 |
| Rituximab | Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Standard Population Set (SPS) | Change at Month 6 (n=26, 20) | -8.31 number of swollen joints | Standard Deviation 6.8 |
| Other Anti-TNF Agent | Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Standard Population Set (SPS) | Baseline (n=31, 24) | 7.13 number of swollen joints | Standard Deviation 6.15 |
| Other Anti-TNF Agent | Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Standard Population Set (SPS) | Change at Month 6 (n=31, 24) | -5.21 number of swollen joints | Standard Deviation 6.35 |
| Other Anti-TNF Agent | Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Standard Population Set (SPS) | Change at Month 6 (n=26, 20) | -5.00 number of swollen joints | Standard Deviation 6.06 |
p-value: 0.2549ANCOVA
p-value: 0.7644ANCOVA
Secondary
Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Intention to Treat (ITT) Population
TJC is a clinical method to quantify abnormalities in participants with RA. It is associated with the level of pain. The number of tender joints were scored as tender=1 and not tender=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of tender joints).
Time frame: Baseline, Month 6 and 12
Population: The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria. Here, 'n' represents the participants who were evaluable at specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab | Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Intention to Treat (ITT) Population | Baseline (n=34, 31) | 13.38 number of tender joints | Standard Deviation 7.22 |
| Rituximab | Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Intention to Treat (ITT) Population | Change at Month 6 (n=34, 31) | -8.21 number of tender joints | Standard Deviation 7.54 |
| Rituximab | Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Intention to Treat (ITT) Population | Change at Month 12 (n=29, 24) | -9.48 number of tender joints | Standard Deviation 7.02 |
| Other Anti-TNF Agent | Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Intention to Treat (ITT) Population | Baseline (n=34, 31) | 8.81 number of tender joints | Standard Deviation 6.88 |
| Other Anti-TNF Agent | Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Intention to Treat (ITT) Population | Change at Month 6 (n=34, 31) | -6.32 number of tender joints | Standard Deviation 7.06 |
| Other Anti-TNF Agent | Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Intention to Treat (ITT) Population | Change at Month 12 (n=29, 24) | -5.96 number of tender joints | Standard Deviation 6.4 |
p-value: 0.3212ANCOVA
p-value: 0.7097ANCOVA
Secondary
Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Standard Population Set (SPS)
TJC is a clinical method to quantify abnormalities in participants with RA. It is associated with the level of pain. The number of tender joints were scored as tender=1 and not tender=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of tender joints).
Time frame: Baseline, Month 6 and 12
Population: The SPS included participants who maintained the secondary biological agent treatment selected for the first time for 6 months among the participants included in the ITT set. Here, 'n' represents the participants who were evaluable at specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab | Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Standard Population Set (SPS) | Baseline (n=31, 24) | 12.87 number of tender joints | Standard Deviation 7.32 |
| Rituximab | Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Standard Population Set (SPS) | Change at Month 6 (n=31, 24) | -7.68 number of tender joints | Standard Deviation 7.55 |
| Rituximab | Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Standard Population Set (SPS) | Change at Month 6 (n=26, 20) | -8.62 number of tender joints | Standard Deviation 6.89 |
| Other Anti-TNF Agent | Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Standard Population Set (SPS) | Baseline (n=31, 24) | 7.79 number of tender joints | Standard Deviation 5.99 |
| Other Anti-TNF Agent | Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Standard Population Set (SPS) | Change at Month 6 (n=31, 24) | -5.79 number of tender joints | Standard Deviation 6.17 |
| Other Anti-TNF Agent | Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Standard Population Set (SPS) | Change at Month 6 (n=26, 20) | -5.80 number of tender joints | Standard Deviation 5.78 |
p-value: 0.2444ANCOVA
p-value: 0.3903ANCOVA
Secondary
Safety: Number of Participants With Adverse Events (AE), Adverse Drug Reactions (ADR) and Serious Adverse Events
An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.
Time frame: Baseline up to Month 12
Population: The ITT set included participants who offered end-point results among the participants who received study drugs after enrollment and met all inclusion/exclusion criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rituximab | Safety: Number of Participants With Adverse Events (AE), Adverse Drug Reactions (ADR) and Serious Adverse Events | Adverse events | 8 participants |
| Rituximab | Safety: Number of Participants With Adverse Events (AE), Adverse Drug Reactions (ADR) and Serious Adverse Events | Adverse drug reactions (ADR) | 4 participants |
| Rituximab | Safety: Number of Participants With Adverse Events (AE), Adverse Drug Reactions (ADR) and Serious Adverse Events | Serious adverse events (SAE) | 3 participants |
| Other Anti-TNF Agent | Safety: Number of Participants With Adverse Events (AE), Adverse Drug Reactions (ADR) and Serious Adverse Events | Adverse events | 8 participants |
| Other Anti-TNF Agent | Safety: Number of Participants With Adverse Events (AE), Adverse Drug Reactions (ADR) and Serious Adverse Events | Adverse drug reactions (ADR) | 5 participants |
| Other Anti-TNF Agent | Safety: Number of Participants With Adverse Events (AE), Adverse Drug Reactions (ADR) and Serious Adverse Events | Serious adverse events (SAE) | 0 participants |