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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituximab | Rituximab administered according to prescribing information and normal clinical practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Biological | Rituximab administered according to prescribing information and normal clinical practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Month 6, Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with severe active, seropositive rheumatoid arthritis who have an inadequate response or intolerance to anti-TNF therapy
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Athens | 11521 | Greece | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Rituximab | Rituximab administered according to prescribing information and normal clinical practice. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rituximab | Rituximab administered according to prescribing information and normal clinical practice. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 6, Month 12 |
|
Up to 12 months
Safety population, defined as all enrolled participants who received at least one dose of rituximab.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rituximab | Rituximab administered according to prescribing information and normal clinical practice. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Baseline, Month 6, Month 12 |
| 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. | Baseline, Month 6, Month 12 |
| 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. | Baseline, Month 6, Month 12 |
| 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. | Baseline, Month 6, Month 12 |
| 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. | Baseline, Month 6, Month 12 |
| 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 | Reasons for discontinuation from baseline to Month 6 are presented as the number of participants who discontinued treatment by category of reason for discontinuation. | Baseline to Month 6 |
| 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. | Baseline to Month 12 |
| 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. | Up to 12 months |
| 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. | Up to 12 months |
| 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. | Up to 12 months |
| 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. | Up to 12 months |
| 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. | Up to 12 months |
| 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. | Up to 12 months |
| 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. | Up to 12 months |
| Athens |
| 11527 |
| Greece |
| Athens | 14527 | Greece |
| Athens | 155 62 | Greece |
| Haidari | 124 62 | Greece |
| Heraklion | 71110 | Greece |
| Ioannina | 455 00 | Greece |
| Larissa | 411 10 | Greece |
| Pátrai | 26335 | Greece |
| Pátrai | 265 04 | Greece |
| Thessaloniki | 544 65 | Greece |
| Thessaloniki | 546 42 | Greece |
| Thessaloniki | 57010 | Greece |
| Voula | 16673 | Greece |
| Patient's Decision Due to Adverse Event |
|
| years |
|
| Sex: Female, Male | Count of Participants | 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. | Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Month 6, Month 12 |
|
|
|
| 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. | Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab. | Posted | Mean | Standard Deviation | swollen joints | Baseline, Month 6, Month 12 |
|
|
|
| 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. | Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab. | Posted | Mean | Standard Deviation | tender joints | Baseline, Month 6, Month 12 |
|
|
|
| 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. | Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab. | Posted | Mean | Standard Deviation | mm/hour | Baseline, Month 6, Month 12 |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | mg/L | Baseline, Month 6, Month 12 |
|
|
|
| Secondary | Percentage of Participants Who Remained on Treatment or Discontinued Treatment by Month 6 and Month 12 | Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab. | Posted | Number | percentage of participants | Up to 12 months |
|
|
|
| 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. | Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab. | Posted | Number | participants | Baseline to Month 6 |
|
|
|
| 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. | Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab. | Posted | Number | participants | Baseline to Month 12 |
|
|
|
| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 12 months |
|
|
|
| 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. | Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab. | Posted | Number | percentage of participants | Up to 12 months |
|
|
|
| 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. | Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab. | Posted | Number | percentage of participants | Up to 12 months |
|
|
|
| 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. | Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab. | Posted | Number | percentage of non-serious AEs | Up to 12 months | Non-Serious AEs | Participants |
|
|
|
| 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. | Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab. | Posted | Number | percentage of non-serious ADRs | Up to 12 months | Non-Serious ADRs | Participants |
|
|
|
| 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. | Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab. | Posted | Number | percentage of serious AEs | Up to 12 months | Serious AEs | 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. | Intention-to Treat population, defined as all enrolled participants who received at least one dose of rituximab. | Posted | Number | percentage of serious ADRs | Up to 12 months | Serious ADRs | Participants |
|
|
|
| 9 |
| 135 |
| 0 |
| 135 |
| Sinusitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
|
| Cerebellar tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA (18.1) | Systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA (18.1) | Systematic Assessment |
|
| Hip arthroplasty | Surgical and medical procedures | MedDRA (18.1) | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
|
| No Response - Month 6 |
|
| Overall - Month 12 |
|
| Good Response - Month 12 |
|
| Moderate Response - Month 12 |
|
| No Response - Month 12 |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
| Discontinued treatment - Month 12 |
|
| Title | Measurements |
|---|---|
|
| Switched physician |
|
| Insurance issues |
|
| Lack of response |
|
| Investigation of reasons for body weight loss |
|
| Title | Measurements |
|---|---|
|
| Lack of response |
|
| Non-satisfactory response |
|
| Adverse reaction (Allergic reaction) |
|
| Adverse reactions (Bradycardia and dermatitis) |
|
| Patient's decision due to adverse event |
|
| Switched physician |
|
| Insurance issues |
|
| Investigation of reasons for body weight loss |
|
| Physician's decision |
|
| Title | Measurements |
|---|---|
|
| Any non-serious ADR |
|
| Any serious AE |
|
| Any serious AE not related to rituximab |
|
| Any serious ADR |
|
| Any AE of special interest related to rituximab |
|
| Title | Measurements |
|---|---|
|
| Any serious AE (Mild) |
|
| Any serious AE (Moderate) |
|
| Any serious AE (Severe) |
|