Rheumatoid Arthritis
Conditions
Brief summary
This observational study will evaluate the effect on disease activity and the safety in routine clinical practice of MabThera (rituximab) in participants with active seropositive rheumatoid arthritis, who have an inadequate response to one or more tumour necrosis factor inhibitor (anti-TNF) therapies.
Interventions
BIOLOGICALRituximab
Rituximab administered according to prescribing information and normal clinical practice.
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
* Age \>18 years with rheumatoid arthritis (RA) * Seropositive participants with RA (positive for rheumatoid factor (RF) and/or anti-Citrullinated Cyclic Peptide \[CCP\]) * Active disease despite receiving one or more TNF inhibitors * Absence of serious or active infection
Exclusion criteria
* Participants with serious history of heart failure (class New York Heart Association \[NYHA\] IV) or severe uncontrolled heart disease * Participants pregnant or lactating * Prior treatment with Mabthera® * Participants receiving any other investigational product in the context of other clinical study * Participants with known hypersensitivity to rituximab or to any of the excipients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Disease Activity Score Based on 28-joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) at Month 6 and Month 12 | Baseline, Month 6, Month 12 | DAS28-ESR is a measure of the participant's disease activity and was calculated using the swollen joint count of 28 joints (SJC28), tender joint count of 28 joints (TJC28), erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment of disease activity (100-millimeter \[mm\] horizontal visual analog scale with 0=no disease activity to 100=maximum disease activity). DAS28-ESR scores range from 0 to 10, with higher scores corresponding to greater disease activity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Swollen Joint Count (SJC) at Month 6 and Month 12 | Baseline, Month 6, Month 12 | 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. The sum of swollen joints, each, ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status. A decrease from baseline indicates improvement. |
| Change From Baseline in Tender Joint Count (TJC) at Month 6 and Month 12 | Baseline, Month 6, Month 12 | 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. A decrease from baseline indicates improvement. |
| Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and Month 12 | Baseline, Month 6, Month 12 | ESR is an direct measure of how much inflammation is in the body. The normal range is 0-22 mm/hour for men and 0-29 mm/hour for women. A decrease from baseline indicates improvement. |
| Change From Baseline in C-reactive Protein (CRP) at Month 6 and Month 12 | Baseline, Month 6, Month 12 | C-reactive protein (CRP) is a blood test marker for inflammation in the body. Normal CRP levels are below 5.0 milligrams per liter (mg/L). A decrease from baseline indicates improvement. |
| Percentage of Participants Who Remained on Treatment or Discontinued Treatment by Month 6 and Month 12 | Up to 12 months | — |
| Reasons for Discontinuation of Treatment by Month 6 | Baseline to Month 6 | Reasons for discontinuation from baseline to Month 6 are presented as the number of participants who discontinued treatment by category of reason for discontinuation. |
| Reasons for Discontinuation of Treatment by Month 12 | Baseline to Month 12 | Reasons for discontinuation from baseline to Month 12 are presented as the number of participants who discontinued treatment by category of reason for discontinuation. |
| Percentage of Participants With European League Against Rheumatism (EULAR) Response at Month 6 and Month 12 | Baseline, Month 6, Month 12 | EULAR response was calculated as the difference between DAS28-ESR scores at baseline and Month 6, and baseline and Month 12, and reported as the percentage of participants with response overall, good response, moderate response, and no response measured at each time point. Good responders = decrease from baseline \>1.2 with a DAS28 score of ≤3.2; moderate responders = decrease from baseline \>1.2 with a DAS28 score of \>3.2, or decrease from baseline \>0.6 to ≤1.2 with a DAS28 score of ≤5.1; non-responders = decrease from baseline ≤0.6 or decrease from baseline \>0.6 and ≤1.2 with a DAS28 score of \>5.1. |
| Percentage of Participants With Adverse Events (AEs) and Adverse Drug Reactions (ADRs) | Up to 12 months | An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An ADR was defined as any noxious and unintended response to a medicinal product related to any dose. AEs of special interest includes progressive multifocal leukoencephalopathy (PML), any encephalopathy, hepatitis B or hepatitis B reactivation, gastrointestinal perforation, tuberculosis (TB) or TB reactivation, opportunistic infections, and malignancies. |
| Percentage of Participants With Any Non-Serious AE and Any Serious AE by Intensity | Up to 12 months | Percentage of participants with any non-serious AE and any serious AE by intensity (mild, moderate, severe) was reported. An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. |
| Percentage of Non-Serious AEs | Up to 12 months | Percentage of non-serious AEs resolved and ongoing at the time of study completion were reported. An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. |
| Percentage of Non-Serious ADRs | Up to 12 months | Percentage of non-serious ADRs at the time of study completion was reported. An ADR was defined as any noxious and unintended response to a medicinal product related to any dose. |
| Percentage of Serious AEs | Up to 12 months | Percentage of serious AEs resolved and ongoing at the time of study completion was reported. An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. |
| Percentage of Serious ADRs | Up to 12 months | Percentage of serious ADRs resolved and ongoing at the time of study completion was reported. An ADR was defined as any noxious and unintended response to a medicinal product related to any dose. |
| Percentage of Participants With Clinically Meaningful Improvement From Baseline in Modified Health Assessment Questionnaire (M-HAQ) | Up to 12 months | The M-HAQ is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. A negative change from baseline indicates improvement. Clinically meaningful improvement was defined as minimum clinically significant reduction from baseline of ≥0.22 at the respective time point. |
Countries
Greece
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rituximab Rituximab administered according to prescribing information and normal clinical practice. | 135 |
| Total | 135 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Patient's Decision Due to Adverse Event | 1 |
| Overall Study | Switched Physician | 1 |
Baseline characteristics
| Characteristic | Rituximab |
|---|---|
| Age, Continuous | 61.2 years STANDARD_DEVIATION 12.5 |
| Sex: Female, Male Female | 115 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 135 |
| serious Total, serious adverse events | 9 / 135 |
Outcome results
Primary
Change From Baseline in Disease Activity Score Based on 28-joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) at Month 6 and Month 12
DAS28-ESR is a measure of the participant's disease activity and was calculated using the swollen joint count of 28 joints (SJC28), tender joint count of 28 joints (TJC28), erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment of disease activity (100-millimeter \[mm\] horizontal visual analog scale with 0=no disease activity to 100=maximum disease activity). DAS28-ESR scores range from 0 to 10, with higher scores corresponding to greater disease activity.
Time frame: Baseline, Month 6, Month 12
Population: Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab | Change From Baseline in Disease Activity Score Based on 28-joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) at Month 6 and Month 12 | Baseline | 5.53 units on a scale | Standard Deviation 1.12 |
| Rituximab | Change From Baseline in Disease Activity Score Based on 28-joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) at Month 6 and Month 12 | Change at Month 6 | -1.52 units on a scale | Standard Deviation 1.36 |
| Rituximab | Change From Baseline in Disease Activity Score Based on 28-joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) at Month 6 and Month 12 | Change at Month 12 | -1.88 units on a scale | Standard Deviation 1.4 |
Comparison: Difference in change at Month 6p-value: <0.001Paired t-test
Comparison: Difference in change at Month 12p-value: <0.001Paired t-test
Secondary
Change From Baseline in C-reactive Protein (CRP) at Month 6 and Month 12
C-reactive protein (CRP) is a blood test marker for inflammation in the body. Normal CRP levels are below 5.0 milligrams per liter (mg/L). A decrease from baseline indicates improvement.
Time frame: Baseline, Month 6, Month 12
Population: Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab. Data at Month 6 and Month 12 are included for participants who had assessments for CRP.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab | Change From Baseline in C-reactive Protein (CRP) at Month 6 and Month 12 | Baseline | 21.8 mg/L | Standard Deviation 39.3 |
| Rituximab | Change From Baseline in C-reactive Protein (CRP) at Month 6 and Month 12 | Change at Month 6 | -10.7 mg/L | Standard Deviation 34.8 |
| Rituximab | Change From Baseline in C-reactive Protein (CRP) at Month 6 and Month 12 | Change at Month 12 | -14.1 mg/L | Standard Deviation 38.1 |
Secondary
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and Month 12
ESR is an direct measure of how much inflammation is in the body. The normal range is 0-22 mm/hour for men and 0-29 mm/hour for women. A decrease from baseline indicates improvement.
Time frame: Baseline, Month 6, Month 12
Population: Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and Month 12 | Baseline | 43.1 mm/hour | Standard Deviation 23.4 |
| Rituximab | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and Month 12 | Change at Month 6 | -14.1 mm/hour | Standard Deviation 22.2 |
| Rituximab | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and Month 12 | Change at Month 12 | -16.3 mm/hour | Standard Deviation 24.1 |
Secondary
Change From Baseline in Swollen Joint Count (SJC) at Month 6 and Month 12
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. The sum of swollen joints, each, ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status. A decrease from baseline indicates improvement.
Time frame: Baseline, Month 6, Month 12
Population: Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab | Change From Baseline in Swollen Joint Count (SJC) at Month 6 and Month 12 | Baseline | 6.4 swollen joints | Standard Deviation 4.6 |
| Rituximab | Change From Baseline in Swollen Joint Count (SJC) at Month 6 and Month 12 | Change at Month 6 | -3.1 swollen joints | Standard Deviation 4.3 |
| Rituximab | Change From Baseline in Swollen Joint Count (SJC) at Month 6 and Month 12 | Change at Month 12 | -3.8 swollen joints | Standard Deviation 4.5 |
Secondary
Change From Baseline in Tender Joint Count (TJC) at Month 6 and Month 12
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. A decrease from baseline indicates improvement.
Time frame: Baseline, Month 6, Month 12
Population: Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rituximab | Change From Baseline in Tender Joint Count (TJC) at Month 6 and Month 12 | Baseline | 8.2 tender joints | Standard Deviation 5.5 |
| Rituximab | Change From Baseline in Tender Joint Count (TJC) at Month 6 and Month 12 | Change at Month 6 | -4.4 tender joints | Standard Deviation 5.3 |
| Rituximab | Change From Baseline in Tender Joint Count (TJC) at Month 6 and Month 12 | Change at Month 12 | -5.1 tender joints | Standard Deviation 5.3 |
Secondary
Percentage of Non-Serious ADRs
Percentage of non-serious ADRs at the time of study completion was reported. An ADR was defined as any noxious and unintended response to a medicinal product related to any dose.
Time frame: Up to 12 months
Population: Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rituximab | Percentage of Non-Serious ADRs | 100.0 percentage of non-serious ADRs |
Secondary
Percentage of Non-Serious AEs
Percentage of non-serious AEs resolved and ongoing at the time of study completion were reported. An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: Up to 12 months
Population: Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rituximab | Percentage of Non-Serious AEs | Resolved | 84.8 percentage of non-serious AEs |
| Rituximab | Percentage of Non-Serious AEs | Ongoing | 15.2 percentage of non-serious AEs |
Secondary
Percentage of Participants Who Remained on Treatment or Discontinued Treatment by Month 6 and Month 12
Time frame: Up to 12 months
Population: Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rituximab | Percentage of Participants Who Remained on Treatment or Discontinued Treatment by Month 6 and Month 12 | Remained on treatment - Month 6 | 93.3 percentage of participants |
| Rituximab | Percentage of Participants Who Remained on Treatment or Discontinued Treatment by Month 6 and Month 12 | Discontinued treatment - Month 6 | 6.7 percentage of participants |
| Rituximab | Percentage of Participants Who Remained on Treatment or Discontinued Treatment by Month 6 and Month 12 | Remained on treatment - Month 12 | 86.7 percentage of participants |
| Rituximab | Percentage of Participants Who Remained on Treatment or Discontinued Treatment by Month 6 and Month 12 | Discontinued treatment - Month 12 | 13.3 percentage of participants |
Secondary
Percentage of Participants With Adverse Events (AEs) and Adverse Drug Reactions (ADRs)
An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An ADR was defined as any noxious and unintended response to a medicinal product related to any dose. AEs of special interest includes progressive multifocal leukoencephalopathy (PML), any encephalopathy, hepatitis B or hepatitis B reactivation, gastrointestinal perforation, tuberculosis (TB) or TB reactivation, opportunistic infections, and malignancies.
Time frame: Up to 12 months
Population: Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rituximab | Percentage of Participants With Adverse Events (AEs) and Adverse Drug Reactions (ADRs) | Any AE | 37.8 percentage of participants |
| Rituximab | Percentage of Participants With Adverse Events (AEs) and Adverse Drug Reactions (ADRs) | Any non-serious AE | 32.6 percentage of participants |
| Rituximab | Percentage of Participants With Adverse Events (AEs) and Adverse Drug Reactions (ADRs) | Any non-serious AE not related to rituximab | 24.4 percentage of participants |
| Rituximab | Percentage of Participants With Adverse Events (AEs) and Adverse Drug Reactions (ADRs) | Any non-serious ADR | 9.6 percentage of participants |
| Rituximab | Percentage of Participants With Adverse Events (AEs) and Adverse Drug Reactions (ADRs) | Any serious AE | 6.7 percentage of participants |
| Rituximab | Percentage of Participants With Adverse Events (AEs) and Adverse Drug Reactions (ADRs) | Any serious AE not related to rituximab | 3.0 percentage of participants |
| Rituximab | Percentage of Participants With Adverse Events (AEs) and Adverse Drug Reactions (ADRs) | Any serious ADR | 3.7 percentage of participants |
| Rituximab | Percentage of Participants With Adverse Events (AEs) and Adverse Drug Reactions (ADRs) | Any AE of special interest related to rituximab | 2.2 percentage of participants |
Secondary
Percentage of Participants With Any Non-Serious AE and Any Serious AE by Intensity
Percentage of participants with any non-serious AE and any serious AE by intensity (mild, moderate, severe) was reported. An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: Up to 12 months
Population: Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rituximab | Percentage of Participants With Any Non-Serious AE and Any Serious AE by Intensity | Any non-serious AE (Mild) | 25.9 percentage of participants |
| Rituximab | Percentage of Participants With Any Non-Serious AE and Any Serious AE by Intensity | Any non-serious AE (Moderate) | 9.6 percentage of participants |
| Rituximab | Percentage of Participants With Any Non-Serious AE and Any Serious AE by Intensity | Any non-serious AE (Severe) | 0.0 percentage of participants |
| Rituximab | Percentage of Participants With Any Non-Serious AE and Any Serious AE by Intensity | Any serious AE (Mild) | 1.5 percentage of participants |
| Rituximab | Percentage of Participants With Any Non-Serious AE and Any Serious AE by Intensity | Any serious AE (Moderate) | 3.0 percentage of participants |
| Rituximab | Percentage of Participants With Any Non-Serious AE and Any Serious AE by Intensity | Any serious AE (Severe) | 2.2 percentage of participants |
Secondary
Percentage of Participants With Clinically Meaningful Improvement From Baseline in Modified Health Assessment Questionnaire (M-HAQ)
The M-HAQ is a participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. A negative change from baseline indicates improvement. Clinically meaningful improvement was defined as minimum clinically significant reduction from baseline of ≥0.22 at the respective time point.
Time frame: Up to 12 months
Population: Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab. Data for change from baseline at Month 6 and Month 12 are included for participants with available data at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rituximab | Percentage of Participants With Clinically Meaningful Improvement From Baseline in Modified Health Assessment Questionnaire (M-HAQ) | Baseline to Month 6 (n = 89) | 65.9 percentage of participants |
| Rituximab | Percentage of Participants With Clinically Meaningful Improvement From Baseline in Modified Health Assessment Questionnaire (M-HAQ) | Baseline to Month 12 (n = 97) | 71.9 percentage of participants |
Secondary
Percentage of Participants With European League Against Rheumatism (EULAR) Response at Month 6 and Month 12
EULAR response was calculated as the difference between DAS28-ESR scores at baseline and Month 6, and baseline and Month 12, and reported as the percentage of participants with response overall, good response, moderate response, and no response measured at each time point. Good responders = decrease from baseline \>1.2 with a DAS28 score of ≤3.2; moderate responders = decrease from baseline \>1.2 with a DAS28 score of \>3.2, or decrease from baseline \>0.6 to ≤1.2 with a DAS28 score of ≤5.1; non-responders = decrease from baseline ≤0.6 or decrease from baseline \>0.6 and ≤1.2 with a DAS28 score of \>5.1.
Time frame: Baseline, Month 6, Month 12
Population: Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rituximab | Percentage of Participants With European League Against Rheumatism (EULAR) Response at Month 6 and Month 12 | Overall - Month 6 | 75.6 percentage of participants |
| Rituximab | Percentage of Participants With European League Against Rheumatism (EULAR) Response at Month 6 and Month 12 | Good Response - Month 6 | 45.2 percentage of participants |
| Rituximab | Percentage of Participants With European League Against Rheumatism (EULAR) Response at Month 6 and Month 12 | Moderate Response - Month 6 | 30.4 percentage of participants |
| Rituximab | Percentage of Participants With European League Against Rheumatism (EULAR) Response at Month 6 and Month 12 | No Response - Month 6 | 24.4 percentage of participants |
| Rituximab | Percentage of Participants With European League Against Rheumatism (EULAR) Response at Month 6 and Month 12 | Overall - Month 12 | 77.0 percentage of participants |
| Rituximab | Percentage of Participants With European League Against Rheumatism (EULAR) Response at Month 6 and Month 12 | Good Response - Month 12 | 40.0 percentage of participants |
| Rituximab | Percentage of Participants With European League Against Rheumatism (EULAR) Response at Month 6 and Month 12 | Moderate Response - Month 12 | 37.0 percentage of participants |
| Rituximab | Percentage of Participants With European League Against Rheumatism (EULAR) Response at Month 6 and Month 12 | No Response - Month 12 | 23.0 percentage of participants |
Secondary
Percentage of Serious ADRs
Percentage of serious ADRs resolved and ongoing at the time of study completion was reported. An ADR was defined as any noxious and unintended response to a medicinal product related to any dose.
Time frame: Up to 12 months
Population: Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rituximab | Percentage of Serious ADRs | Resolved | 80.0 percentage of serious ADRs |
| Rituximab | Percentage of Serious ADRs | Ongoing | 20.0 percentage of serious ADRs |
Secondary
Percentage of Serious AEs
Percentage of serious AEs resolved and ongoing at the time of study completion was reported. An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Time frame: Up to 12 months
Population: Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rituximab | Percentage of Serious AEs | Resolved | 88.9 percentage of serious AEs |
| Rituximab | Percentage of Serious AEs | Ongoing | 11.1 percentage of serious AEs |
Secondary
Reasons for Discontinuation of Treatment by Month 12
Reasons for discontinuation from baseline to Month 12 are presented as the number of participants who discontinued treatment by category of reason for discontinuation.
Time frame: Baseline to Month 12
Population: Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rituximab | Reasons for Discontinuation of Treatment by Month 12 | Disease remission | 3 participants |
| Rituximab | Reasons for Discontinuation of Treatment by Month 12 | Lost to follow-up | 5 participants |
| Rituximab | Reasons for Discontinuation of Treatment by Month 12 | Lack of efficacy | 1 participants |
| Rituximab | Reasons for Discontinuation of Treatment by Month 12 | Lack of response | 1 participants |
| Rituximab | Reasons for Discontinuation of Treatment by Month 12 | Non-satisfactory response | 1 participants |
| Rituximab | Reasons for Discontinuation of Treatment by Month 12 | Adverse reaction (Allergic reaction) | 1 participants |
| Rituximab | Reasons for Discontinuation of Treatment by Month 12 | Adverse reactions (Bradycardia and dermatitis) | 1 participants |
| Rituximab | Reasons for Discontinuation of Treatment by Month 12 | Patient's decision due to adverse event | 1 participants |
| Rituximab | Reasons for Discontinuation of Treatment by Month 12 | Switched physician | 1 participants |
| Rituximab | Reasons for Discontinuation of Treatment by Month 12 | Insurance issues | 1 participants |
| Rituximab | Reasons for Discontinuation of Treatment by Month 12 | Investigation of reasons for body weight loss | 1 participants |
| Rituximab | Reasons for Discontinuation of Treatment by Month 12 | Physician's decision | 1 participants |
Secondary
Reasons for Discontinuation of Treatment by Month 6
Reasons for discontinuation from baseline to Month 6 are presented as the number of participants who discontinued treatment by category of reason for discontinuation.
Time frame: Baseline to Month 6
Population: Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rituximab | Reasons for Discontinuation of Treatment by Month 6 | Disease remission | 2 participants |
| Rituximab | Reasons for Discontinuation of Treatment by Month 6 | Lost to follow-up | 2 participants |
| Rituximab | Reasons for Discontinuation of Treatment by Month 6 | Adverse reaction (Allergic reaction) | 1 participants |
| Rituximab | Reasons for Discontinuation of Treatment by Month 6 | Switched physician | 1 participants |
| Rituximab | Reasons for Discontinuation of Treatment by Month 6 | Insurance issues | 1 participants |
| Rituximab | Reasons for Discontinuation of Treatment by Month 6 | Lack of response | 1 participants |
| Rituximab | Reasons for Discontinuation of Treatment by Month 6 | Investigation of reasons for body weight loss | 1 participants |