Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| WA17045 | Other Identifier | F. Hoffmann-La Roche |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hoffmann-La Roche | INDUSTRY |
This study evaluated the efficacy and safety of rituximab in patients with active rheumatoid arthritis (RA).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo + methotrexate (MTX) | Active Comparator | Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 milligrams (mg) intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
|
| Rituximab 2 x 0.5 g + MTX | Experimental | Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
|
| Rituximab 2 x 1.0 g + MTX | Experimental | Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Folate | Drug | A stable dose, ≥ 5 mg/week given as either a single dose or as a divided weekly dose, orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24 | To achieve an ACR20 required at least a 20% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 20% improvement in three of the following five additional measurements:
Participants who withdrew prematurely from the study prior to Week 24, who received rescue therapy or had insufficient data in order to calculate a clinical response were considered to be non-responders. | Baseline and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an ACR50 Response at Week 24 | To achieve an ACR50 required at least a 50% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 50% improvement in three of the following five additional measurements:
Participants who withdrew prematurely from the study prior to Week 24, who received rescue therapy or had insufficient data in order to calculate a clinical response were considered to be non-responders. |
Not provided
Inclusion criteria:
Adult patients 18-80 years of age.
Rheumatoid arthritis (RA) for ≥ 6 months, diagnosed according to the revised 1987 American College of Rheumatology (ACR) criteria for the classification of rheumatoid arthritis.
Receiving outpatient treatment for RA.
Swollen joint count (SJC) ≥ 8 (66 joint count), and tender joint count (TJC) ≥ 8 (68 joint count) at screening and baseline.
At screening, either
Inadequate response to methotrexate, having received and tolerated at a dose of 10-25 mg/week it for ≥ 12 weeks.
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20488885 | Result | Emery P, Deodhar A, Rigby WF, Isaacs JD, Combe B, Racewicz AJ, Latinis K, Abud-Mendoza C, Szczepanski LJ, Roschmann RA, Chen A, Armstrong GK, Douglass W, Tyrrell H. Efficacy and safety of different doses and retreatment of rituximab: a randomised, placebo-controlled trial in patients who are biological naive with active rheumatoid arthritis and an inadequate response to methotrexate (Study Evaluating Rituximab's Efficacy in MTX iNadequate rEsponders (SERENE)). Ann Rheum Dis. 2010 Sep;69(9):1629-35. doi: 10.1136/ard.2009.119933. Epub 2010 May 20. | |
| 22127691 |
Not provided
Not provided
Of the 509 participants, one participant was randomized first to rituximab 2 x 1.0 g + MTX and then to rituximab 2 x 0.5 g + MTX. No assessments were recorded or medication given after first randomization and all data used in analyses was following the second randomization; hence, participant is included only in rituximab 2 x 0.5 g + MTX arm.
A total of 511 participants were recruited and randomized between 27 Oct 2005 and 15 Nov 2006. Of these, 2 participants were randomized but received no infusions (one violated inclusion criteria and the other was randomized to rituximab 2 x 1.0 gram [g] + methotrexate [MTX] but failed to return). A total of 509 participants were treated.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo + MTX | Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 milligrams (mg) intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period (up to 5 Years) |
|
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Methotrexate | Drug | A stable dose of between 10-25 mg/week, oral or parenteral, as prescribed by the treating physician. |
|
| Methylprednisolone | Drug | Intravenous infusion |
|
| Placebo | Drug | Placebo to rituximab intravenous infusion |
|
| Rituximab | Drug | Intravenous infusion |
|
|
| Baseline and Week 24 |
| Percentage of Participants With an ACR70 Response at Week 24 | To achieve an ACR70 required at least a 70% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 70% improvement in three of the following five additional measurements:
Participants who withdrew prematurely from the study prior to Week 24, who received rescue therapy or had insufficient data in order to calculate a clinical response were considered to be non-responders. | Baseline and Week 24 |
| Change From Baseline in Disease Activity Score (DAS28-ESR) at Week 24 | The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:
The DAS28 score ranges from zero to ten. A DAS28 score above 5.1 means high disease activity whereas a DAS28 less than or equal to 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6. | Baseline and Week 24 |
| Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 24 | A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score of less than or equal to 3.2. A Moderate Response is defined as either:
No Response is defined as either an improvement (decrease) in the DAS28 of less than or equal to 0.6, or an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 of more than 5.1. | Baseline and Week 24 |
| Percent Change From Baseline in Swollen Joint Count | Sixty-six joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The percentage change from baseline at each post-baseline visit was calculated as: [(post-baseline value minus baseline value) divided by Baseline value]*100. A negative percentage change from baseline score indicates an improvement. | Baseline, Week 24 and Week 48 |
| Percent Change From Baseline in Tender Joint Count | Sixty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The percentage change from baseline at each post-baseline visit was calculated as: [(post-baseline value minus baseline value) divided by Baseline value]*100. A negative percentage change from baseline score indicates an improvement. | Baseline, Week 24 and Week 48 |
| Percent Change From Baseline in Patient's Global Assessment of Disease Activity | The participant's overall assessment of their current disease activity measured on a 100 mm horizontal visual analog scale (VAS). The left-hand extreme of the line (0 mm) was described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme (100 mm) as "maximum disease activity" (maximum arthritis disease activity). The percentage change from baseline at each post-baseline visit was calculated as: [(post-baseline value minus baseline value) divided by Baseline value]*100. A negative percentage change from baseline score indicates an improvement. | Baseline, Week 24 and Week 48 |
| Percent Change From Baseline in Patient's Pain Assessment | The participant's assessment of their current level of pain on a 100 mm horizontal visual analog scale (VAS), where the left-hand extreme of the line (0 mm) was described as "no pain" and the right-hand extreme (100 mm) as "unbearable pain". The percentage change from baseline at each post-baseline visit was calculated as: [(post-baseline value minus baseline value) divided by Baseline value]*100. A negative percentage change from baseline score indicates an improvement. | Baseline, Week 24 and Week 48 |
| Percent Change From Baseline in Physician's Global Assessment of Disease Activity | The physician's assessment of the participant's current disease activity on a 100 mm horizontal VAS, where the left-hand extreme of the line (0 mm) was described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme (100 mm) as "maximum disease activity". The percentage change from baseline at each post-baseline visit was calculated as: [(post-baseline value minus baseline value) divided by Baseline value]*100. A negative percentage change from baseline score indicates an improvement. | Baseline, Week 24 and Week 48 |
| Percent Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score | The Stanford Health Assessment Questionnaire disability index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants choose from four response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The percentage change from baseline at each post-baseline visit was calculated as: [(post-baseline value minus baseline value) divided by Baseline value]*100. A negative percentage change from baseline score indicates an improvement. | Baseline, Week 24 and Week 48 |
| Percent Change From Baseline in C-Reactive Protein | C-Reactive Protein (CRP) was measured from blood samples by a central laboratory as a marker for inflammation. The percentage change from baseline at each post-baseline visit was calculated as: [(post-baseline value minus baseline value) divided by Baseline value]*100. A negative percentage change from baseline score indicates an improvement. | Baseline, Week 24 and Week 48 |
| Percent Change From Baseline in Erythrocyte Sedimentation Rate | Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation. The percentage change from baseline at each post-baseline visit was calculated as: [(post-baseline value minus baseline value) divided by Baseline value]*100. A negative percentage change from baseline score indicates an improvement. | Baseline, Week 24 and Week 48 |
| Percent Change From Baseline in Short Form 36 Health Survey (SF-36) Summary Scores (Physical and Mental Components) | The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions split into two major components: physical health and mental health. Under physical health are the following four domains: physical health, bodily pain, physical functioning and physical role limitations. Under the mental health domain there are four domains; mental health, vitality, social functioning, and emotional role limitation. The individual domain scores are aggregated to derive a physical-component summary score and a mental-component summary score which range from 0 to 100, with higher scores indicating a better level of functioning. The percentage change from baseline at each post-baseline visit was calculated as: [(post-baseline value minus baseline value) divided by Baseline value]*100. A positive percentage change from baseline score indicates an improvement. | Baseline, Week 24 and Week 48 |
| Change From Baseline in Short Form 36 Health Survey (SF-36) General Health Domain Score | The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. A positive change from baseline score indicates an improvement. | Baseline, Week 24 and Week 48 |
| Change From Baseline in Short Form 36 Health Survey (SF-36) Bodily Pain Domain Score | The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. A positive change from baseline score indicates an improvement. | Baseline, Week 24 and Week 48 |
| Change From Baseline in Short Form 36 Health Survey (SF-36) Physical Functioning Domain Score | The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. A positive change from baseline score indicates an improvement. | Baseline, Week 24 and Week 48 |
| Change From Baseline in Short Form 36 Health Survey (SF-36) Physical Role Limitations Domain Score | The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. A positive change from baseline score indicates an improvement. | Baseline, Week 24 and Week 48 |
| Change From Baseline in Short Form 36 Health Survey (SF-36) Mental Health Domain Score | The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. A positive change from baseline score indicates an improvement. | Baseline, Week 24 and Week 48 |
| Change From Baseline in Short Form 36 Health Survey (SF-36) Vitality Domain Score | The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. A positive change from baseline score indicates an improvement. | Baseline, Week 24 and Week 48 |
| Change From Baseline in Short Form 36 Health Survey (SF-36) Social Functioning Domain Score | The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. A positive change from baseline score indicates an improvement. | Baseline, Week 24 and Week 48 |
| Change From Baseline in Short Form 36 Health Survey (SF-36) Emotional Role Limitations Domain Score | The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. A positive change from baseline score indicates an improvement. | Baseline, Week 24 and Week 48 |
| Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Scores | The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days. Participants respond to the questions using a value in the range of 0 (not at all) to 4 (very much). The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue. A positive change from baseline score indicates an improvement. | Baseline, Week 24 and Week 48 |
| Percentage of Participants With DAS28-ESR Low Disease Activity Score and Clinical Remission at Week 24 | The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:
The DAS28 score ranges from zero to ten. DAS28 above 5.1 indicates high disease activity. Low disease activity is defined by a DAS28 score less than or equal to 3.2. Remission is defined by a DAS28 score less than 2.6. | Week 24 |
| Percentage of Participants With HAQ-DI Improved, Unchanged or Worsened at Week 24 | The Stanford Health Assessment Questionnaire disability index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants choose from four response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative change from baseline score indicates an improvement. Improved HAQ-DI is defined as a change from Baseline score less than or equal to -0.22. An Unchanged HAQ-DI is defined as a change from Baseline score greater than -0.22 and less than 0.22. A worsened HAQ-DI score is defined as a change from Baseline score of greater than or equal to 0.22. | Baseline and Week 24 |
| Percentage of Participants With HAQ-DI Improved, Unchanged or Worsened at Week 48 | The Stanford Health Assessment Questionnaire disability index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants choose from four response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative change from baseline score indicates an improvement. Improved HAQ-DI is defined as a change from Baseline score less than or equal to -0.22. An Unchanged HAQ-DI is defined as a change from Baseline score greater than -0.22 and less than 0.22. A worsened HAQ-DI score is defined as a change from Baseline score of greater than or equal to 0.22. | Baseline and Week 48 |
| Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 48 | A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2. A Moderate Response is defined as either:
No Response is defined as either an improvement (decrease) in the DAS28 of less than or equal to 0.6, or an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of 5.1 or higher. | Baseline and Week 48 |
| Percentage of Participants With DAS28-ESR Low Disease Activity Score and Clinical Remission at Week 48 | The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:
The DAS28 score ranges from zero to ten. DAS28 above 5.1 indicates high disease activity. Low disease activity is defined by a DAS28 score less than or equal to 3.2. Remission is defined by a DAS28 score less than 2.6. | Week 48 |
| Percentage of Participants With an ACR50 Response at Week 48 | To achieve an ACR50 required at least a 50% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 50% improvement in three of the following five additional measurements:
Participants who withdrew prematurely from the study prior to week 48, who received rescue therapy or had insufficient data in order to calculate a clinical response were considered to be non-responders. | Baseline and Week 48 |
| Percentage of Participants With an ACR70 Response at Week 48 | To achieve an ACR70 required at least a 70% improvement compared with baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 70% improvement in three of the following five additional measurements:
Participants who withdrew prematurely from the study prior to Week 48, who received rescue therapy or had insufficient data in order to calculate a clinical response were considered to be non-responders. | Baseline and Week 48 |
| Derived |
| Lal P, Su Z, Holweg CT, Silverman GJ, Schwartzman S, Kelman A, Read S, Spaniolo G, Monroe JG, Behrens TW, Townsend MJ. Inflammation and autoantibody markers identify rheumatoid arthritis patients with enhanced clinical benefit following rituximab treatment. Arthritis Rheum. 2011 Dec;63(12):3681-91. doi: 10.1002/art.30596. |
| FG001 | Rituximab 2 x 0.5 g + MTX | Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
| FG002 | Rituximab 2 x 1.0 g + MTX | Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
| Treated |
|
| Completed 24 Weeks |
|
| Completed 48 Weeks |
|
| Completed 144 Weeks |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Safety Follow-up (SFU) (48 Weeks) |
|
|
| Extended SFU (ESFU) (up to 5.1 Years) |
|
|
Safety population included all randomized participants who received any part of an infusion.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo + MTX | Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
| BG001 | Rituximab 2 x 0.5 g + MTX | Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
| BG002 | Rituximab 2 x 1.0 g + MTX | Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Week 24 | To achieve an ACR20 required at least a 20% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 20% improvement in three of the following five additional measurements:
Participants who withdrew prematurely from the study prior to Week 24, who received rescue therapy or had insufficient data in order to calculate a clinical response were considered to be non-responders. | Intent to treat population included all randomized participants who received at least 1 or part of an infusion. ACR was calculated using the last observation carried forward (LOCF) values for each component. Participants who withdrew prior to week 24, received rescue therapy or had insufficient data to calculate ACR were considered non-responders. | Posted | Number | percentage of participants | Baseline and Week 24 |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With an ACR50 Response at Week 24 | To achieve an ACR50 required at least a 50% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 50% improvement in three of the following five additional measurements:
Participants who withdrew prematurely from the study prior to Week 24, who received rescue therapy or had insufficient data in order to calculate a clinical response were considered to be non-responders. | Intent to treat population. ACR was calculated using LOCF values for each component. Participants who withdrew prior to Week 24, received rescue therapy or had insufficient data to calculate ACR were considered non-responders. | Posted | Number | percentage of participants | Baseline and Week 24 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With an ACR70 Response at Week 24 | To achieve an ACR70 required at least a 70% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 70% improvement in three of the following five additional measurements:
Participants who withdrew prematurely from the study prior to Week 24, who received rescue therapy or had insufficient data in order to calculate a clinical response were considered to be non-responders. | Intent to treat population. ACR was calculated using LOCF values for each component. Participants who withdrew prior to Week 24, received rescue therapy or had insufficient data to calculate ACR were considered non-responders. | Posted | Number | percentage of participants | Baseline and Week 24 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Disease Activity Score (DAS28-ESR) at Week 24 | The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:
The DAS28 score ranges from zero to ten. A DAS28 score above 5.1 means high disease activity whereas a DAS28 less than or equal to 3.2 indicates low disease activity. Remission is achieved by a DAS28 lower than 2.6. | Intent to treat population with available data. DAS28 was calculated using last observation carried forward values for each of the component variables. If any of the components were missing then the DAS28 value will be missing. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Week 24 |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 24 | A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score of less than or equal to 3.2. A Moderate Response is defined as either:
No Response is defined as either an improvement (decrease) in the DAS28 of less than or equal to 0.6, or an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 of more than 5.1. | Intent-to-treat population. LOCF was used for the individual components of the DAS-28. Non-responder imputation was used. Participants who withdrew prior to Week 24, who received rescue therapy or had insufficient data in order to calculate a EULAR response were considered non-responders. | Posted | Number | percentage of participants | Baseline and Week 24 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Swollen Joint Count | Sixty-six joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination. The percentage change from baseline at each post-baseline visit was calculated as: [(post-baseline value minus baseline value) divided by Baseline value]*100. A negative percentage change from baseline score indicates an improvement. | Intent-to-treat population, LOCF was used. "N" indicates the number of participants with non-missing data at each time point. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 24 and Week 48 |
| |||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Tender Joint Count | Sixty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination. The percentage change from baseline at each post-baseline visit was calculated as: [(post-baseline value minus baseline value) divided by Baseline value]*100. A negative percentage change from baseline score indicates an improvement. | Intent-to-treat population, LOCF was used. "N" indicates the number of participants with non-missing data at each time point. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 24 and Week 48 |
| |||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Patient's Global Assessment of Disease Activity | The participant's overall assessment of their current disease activity measured on a 100 mm horizontal visual analog scale (VAS). The left-hand extreme of the line (0 mm) was described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme (100 mm) as "maximum disease activity" (maximum arthritis disease activity). The percentage change from baseline at each post-baseline visit was calculated as: [(post-baseline value minus baseline value) divided by Baseline value]*100. A negative percentage change from baseline score indicates an improvement. | Intent-to-treat population, LOCF was used. "N" indicates the number of participants with non-missing data at each time point. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 24 and Week 48 |
| |||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Patient's Pain Assessment | The participant's assessment of their current level of pain on a 100 mm horizontal visual analog scale (VAS), where the left-hand extreme of the line (0 mm) was described as "no pain" and the right-hand extreme (100 mm) as "unbearable pain". The percentage change from baseline at each post-baseline visit was calculated as: [(post-baseline value minus baseline value) divided by Baseline value]*100. A negative percentage change from baseline score indicates an improvement. | Intent-to-treat population, LOCF was used. "N" indicates the number of participants with non-missing data at each time point. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 24 and Week 48 |
| |||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Physician's Global Assessment of Disease Activity | The physician's assessment of the participant's current disease activity on a 100 mm horizontal VAS, where the left-hand extreme of the line (0 mm) was described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme (100 mm) as "maximum disease activity". The percentage change from baseline at each post-baseline visit was calculated as: [(post-baseline value minus baseline value) divided by Baseline value]*100. A negative percentage change from baseline score indicates an improvement. | Intent-to-treat population, LOCF was used. "N" indicates the number of participants with non-missing data at each time point. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 24 and Week 48 |
| |||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score | The Stanford Health Assessment Questionnaire disability index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants choose from four response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The percentage change from baseline at each post-baseline visit was calculated as: [(post-baseline value minus baseline value) divided by Baseline value]*100. A negative percentage change from baseline score indicates an improvement. | Intent-to-treat population, LOCF was used. "N" indicates the number of participants with non-missing data at each time point. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 24 and Week 48 |
| |||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in C-Reactive Protein | C-Reactive Protein (CRP) was measured from blood samples by a central laboratory as a marker for inflammation. The percentage change from baseline at each post-baseline visit was calculated as: [(post-baseline value minus baseline value) divided by Baseline value]*100. A negative percentage change from baseline score indicates an improvement. | Intent-to-treat population, LOCF was used. "N" indicates the number of participants with non-missing data at each time point. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 24 and Week 48 |
| |||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Erythrocyte Sedimentation Rate | Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation. The percentage change from baseline at each post-baseline visit was calculated as: [(post-baseline value minus baseline value) divided by Baseline value]*100. A negative percentage change from baseline score indicates an improvement. | Intent-to-treat population, LOCF was used. "N" indicates the number of participants with non-missing data at each time point. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 24 and Week 48 |
| |||||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Short Form 36 Health Survey (SF-36) Summary Scores (Physical and Mental Components) | The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions split into two major components: physical health and mental health. Under physical health are the following four domains: physical health, bodily pain, physical functioning and physical role limitations. Under the mental health domain there are four domains; mental health, vitality, social functioning, and emotional role limitation. The individual domain scores are aggregated to derive a physical-component summary score and a mental-component summary score which range from 0 to 100, with higher scores indicating a better level of functioning. The percentage change from baseline at each post-baseline visit was calculated as: [(post-baseline value minus baseline value) divided by Baseline value]*100. A positive percentage change from baseline score indicates an improvement. | Intent-to-treat population, LOCF was used. "N" indicates the number of participants with non-missing data at each time point. | Posted | Mean | Standard Deviation | percent change | Baseline, Week 24 and Week 48 |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Short Form 36 Health Survey (SF-36) General Health Domain Score | The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. A positive change from baseline score indicates an improvement. | Intent-to-treat population. "N" indicates the number of participants with non-missing data at each time point. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 24 and Week 48 |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Short Form 36 Health Survey (SF-36) Bodily Pain Domain Score | The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. A positive change from baseline score indicates an improvement. | Intent-to-treat population. "N" indicates the number of participants with non-missing data at each time point. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 24 and Week 48 |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Short Form 36 Health Survey (SF-36) Physical Functioning Domain Score | The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. A positive change from baseline score indicates an improvement. | Intent-to-treat population. "N" indicates the number of participants with non-missing data at each time point. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 24 and Week 48 |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Short Form 36 Health Survey (SF-36) Physical Role Limitations Domain Score | The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. A positive change from baseline score indicates an improvement. | Intent-to-treat population. "N" indicates the number of participants with non-missing data at each time point. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 24 and Week 48 |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Short Form 36 Health Survey (SF-36) Mental Health Domain Score | The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. A positive change from baseline score indicates an improvement. | Intent-to-treat population. "N" indicates the number of participants with non-missing data at each time point. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 24 and Week 48 |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Short Form 36 Health Survey (SF-36) Vitality Domain Score | The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. A positive change from baseline score indicates an improvement. | Intent-to-treat population. "N" indicates the number of participants with non-missing data at each time point. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 24 and Week 48 |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Short Form 36 Health Survey (SF-36) Social Functioning Domain Score | The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. A positive change from baseline score indicates an improvement. | Intent-to-treat population. "N" indicates the number of participants with non-missing data at each time point. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 24 and Week 48 |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Short Form 36 Health Survey (SF-36) Emotional Role Limitations Domain Score | The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. A positive change from baseline score indicates an improvement. | Intent-to-treat population. "N" indicates the number of participants with non-missing data at each time point. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 24 and Week 48 |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Scores | The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days. Participants respond to the questions using a value in the range of 0 (not at all) to 4 (very much). The scale score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue subscale score ranges from 0 to 52, where higher scores represent less fatigue. A positive change from baseline score indicates an improvement. | Intent-to-treat population, LOCF was used. "N" indicates the number of participants with non-missing data at each time point. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 24 and Week 48 |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With DAS28-ESR Low Disease Activity Score and Clinical Remission at Week 24 | The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:
The DAS28 score ranges from zero to ten. DAS28 above 5.1 indicates high disease activity. Low disease activity is defined by a DAS28 score less than or equal to 3.2. Remission is defined by a DAS28 score less than 2.6. | Intent to treat population with available data. DAS28 was calculated using last observation carried forward values for each of the component variables. If any of the components were missing then the DAS28 value will be missing. Number of participants analyzed = participants who were evaluable for this outcome. | Posted | Number | percentage of participants | Week 24 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HAQ-DI Improved, Unchanged or Worsened at Week 24 | The Stanford Health Assessment Questionnaire disability index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants choose from four response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative change from baseline score indicates an improvement. Improved HAQ-DI is defined as a change from Baseline score less than or equal to -0.22. An Unchanged HAQ-DI is defined as a change from Baseline score greater than -0.22 and less than 0.22. A worsened HAQ-DI score is defined as a change from Baseline score of greater than or equal to 0.22. | Intent-to-treat population including participants with available data. LOCF was used. | Posted | Number | percentage of participants | Baseline and Week 24 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HAQ-DI Improved, Unchanged or Worsened at Week 48 | The Stanford Health Assessment Questionnaire disability index is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants choose from four response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. A negative change from baseline score indicates an improvement. Improved HAQ-DI is defined as a change from Baseline score less than or equal to -0.22. An Unchanged HAQ-DI is defined as a change from Baseline score greater than -0.22 and less than 0.22. A worsened HAQ-DI score is defined as a change from Baseline score of greater than or equal to 0.22. | Intent-to-treat population including participants with available data. LOCF was used. | Posted | Number | percentage of participants | Baseline and Week 48 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 48 | A EULAR response reflects an improvement in disease activity and an attainment of a lower degree of disease activity based on the DAS-28 score. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score less than or equal to 3.2. A Moderate Response is defined as either:
No Response is defined as either an improvement (decrease) in the DAS28 of less than or equal to 0.6, or an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 score of 5.1 or higher. | Intent-to-treat population. LOCF was used for the individual components of the DAS-28. Non-responder imputation was used. Patients who withdrew prior to week 48, who received rescue therapy or had insufficient data in order to calculate a EULAR response were considered non-responders. | Posted | Number | percentage of participants | Baseline and Week 48 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With DAS28-ESR Low Disease Activity Score and Clinical Remission at Week 48 | The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:
The DAS28 score ranges from zero to ten. DAS28 above 5.1 indicates high disease activity. Low disease activity is defined by a DAS28 score less than or equal to 3.2. Remission is defined by a DAS28 score less than 2.6. | Intent to treat population including participants with available data. DAS28 was calculated using last observation carried forward values for each of the component variables. If any of the components were missing then the DAS28 value will be missing. | Posted | Number | percentage of participants | Week 48 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With an ACR50 Response at Week 48 | To achieve an ACR50 required at least a 50% improvement compared with Baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 50% improvement in three of the following five additional measurements:
Participants who withdrew prematurely from the study prior to week 48, who received rescue therapy or had insufficient data in order to calculate a clinical response were considered to be non-responders. | Intent to treat population. ACR was calculated using LOCF values for each component. Participants who withdrew prior to Week 48, received rescue therapy or had insufficient data to calculate ACR were considered non-responders. | Posted | Number | percentage of participants | Baseline and Week 48 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With an ACR70 Response at Week 48 | To achieve an ACR70 required at least a 70% improvement compared with baseline in both tender joint counts (68 joints assessed for tenderness) and swollen joint counts (66 joints assessed for swelling), as well as a 70% improvement in three of the following five additional measurements:
Participants who withdrew prematurely from the study prior to Week 48, who received rescue therapy or had insufficient data in order to calculate a clinical response were considered to be non-responders. | Intent to treat population. ACR was calculated using LOCF values for each component. Participants who withdrew prior to Week 48, received rescue therapy or had insufficient data to calculate ACR were considered non-responders. | Posted | Number | percentage of participants | Baseline and Week 48 |
| ||||||||||||||||||||||||||||||||||
| Post-Hoc | Time to Repletion of Peripheral CD19+ B-cells | Peripheral CD19+ B-cell repletion was defined as a CD19+ B-cell count that returned to the Baseline value or returned to ≥ the lower limit of normal, whichever was lower. | Extended safety follow-up population: All participants who were randomized, received any part of a rituximab infusion, and entered the extended safety follow-up period. | Posted | Median | 95% Confidence Interval | Weeks | Beginning of the first infusion (Day 1) in the last treatment cycle until repletion or the end of the study (approximately 6.5 years) |
| |||||||||||||||||||||||||||||||||
| Post-Hoc | Percentage of Participants With Low Immunoglobulin Concentrations Pre- and Post-Rituximab Treatment | A low immunoglobulin concentration was defined as a concentration below the lower level of normal. | Safety follow-up population: All participants who were randomized and received any part of a rituximab infusion. Number of participants analyzed = participants with available data. "N" indicates the number of participants with non-missing data at each time point. | Posted | Number | Percentage of participants | Baseline (pre-rituximab), Beginning of the safety follow-up period to the end of the study (approximately 6 years) (post-rituximab) |
|
|
Up to 5.1 years after last dose in treatment period (treatment period = up to 5 years)
During the 5-year treatment period, all adverse events (AEs) regardless of seriousness were reported. During the standard 48-week safety follow-up (SFU) and extended safety follow-up (ESFU), all serious adverse events (SAEs) and all non-serious infections were reported.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo + MTX | Includes all data for participants who remained on placebo, and data up to the point of switch if the participant switched to treatment with rituximab. Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. | 16 | 172 | 112 | 172 | ||
| EG001 | Rituximab 2 x 0.5 g + MTX | Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. | 52 | 167 | 149 | 167 | ||
| EG002 | Rituximab 1.0 g + MTX | Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. | 46 | 170 | 151 | 170 | ||
| EG003 | Switch Population: Placebo + MTX | Includes all data up to the point of switch for participants in the Placebo + Methotrexate treatment group who switched to treatment with rituximab after Week 24. | 12 | 155 | 99 | 155 | ||
| EG004 | Switch Population: Rituximab | Includes all data from the point of switch for participants who switched from Placebo + Methotrexate to treatment with rituximab. | 45 | 155 | 131 | 155 | ||
| EG005 | Rituximab 2 x 0.5 g + MTX - Extended Safety Follow-up Period | Participants received no treatment during the extended safety follow-up period. | 8 | 82 | 5 | 82 | ||
| EG006 | Rituximab 2 x 1.0 g + MTX - Extended Safety Follow-up Period | Participants received no treatment during the extended safety follow-up period. | 2 | 44 | 2 | 44 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Abdominal sepsis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Abscess soft tissue | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Arthritis infective | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Tubo-ovarian abscess | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Stress fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Synovial rupture | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Traumatic coma | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Muscular weaknes | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Spondyloarthropathy | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Femoral hernia, obstructive | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Ileal ulcer | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Inguinal hernia, obstructive | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Retroperitoneal haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Volvulus | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Aortic valve incompetence | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pleuropericarditis | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Lung squamous cell carcinoma stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
| |
| Non-small cell lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
| |
| Oesophageal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
| |
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
| |
| Squamous cell carcinoma of the cervix | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
| |
| T-cell prolymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Demyelination | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Benign intracranial hypertension | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Diabetic hyperosmolar coma | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Radiculopathy | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Vaginal prolapse | Reproductive system and breast disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cystocele | Reproductive system and breast disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Postmenopausal haemorrhage | Reproductive system and breast disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Testicular necrosis | Reproductive system and breast disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Device failure | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Fibrosis | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hernia obstructive | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Intra-abdominal haematoma | Vascular disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 16.0 | Non-systematic Assessment |
| |
| Abortion threatened | Pregnancy, puerperium and perinatal conditions | MedDRA 16.0 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hepatitis B DNA increased | Investigations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Lichen planus | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Abdominal wall haematoma | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 16.0 | Non-systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 16.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA 16.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 16.0 | Non-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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffman-La Roche | 800-821-8590 | genentech@druginfo.com |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005492 | Folic Acid |
| D008727 | Methotrexate |
| D008775 | Methylprednisolone |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000630 | Aminopterin |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Did not Co-operate |
|
| Failure to Return |
|
| No SFU Week 48 Date Recorded |
|
| Withdrawal by Subject |
|
| Did not Cooperate/Withdrew Consent |
|
| Male |
|
| OG001 | Rituximab 2 x 0.5 g + MTX | Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
| OG002 | Rituximab 2 x 1.0 g + MTX | Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
|
|
| OG001 | Rituximab 2 x 0.5 g + MTX | Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
| OG002 | Rituximab 2 x 1.0 g + MTX | Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
|
|
| Rituximab 2 x 0.5 g + MTX |
Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
| OG002 | Rituximab 2 x 1.0 g + MTX | Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
|
|
| OG001 | Rituximab 2 x 0.5 g + MTX | Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
| OG002 | Rituximab 2 x 1.0 g + MTX | Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
|
|
| OG002 | Rituximab 2 x 1.0 g + MTX | Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
|
|
| OG002 | Rituximab 2 x 1.0 g + MTX | Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
|
|
Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
| OG002 | Rituximab 2 x 1.0 g + MTX | Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
|
|
| OG002 | Rituximab 2 x 1.0 g + MTX | Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
|
|
Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.
Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.
All participants entered a 48-week safety follow-up (SFU) period following the treatment period.
| OG002 | Rituximab 2 x 1.0 g + MTX | Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
|
|
| OG001 | Rituximab 2 x 0.5 g + MTX | Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
| OG002 | Rituximab 2 x 1.0 g + MTX | Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
|
|
| OG002 | Rituximab 2 x 1.0 g + MTX | Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
|
|
| OG002 | Rituximab 2 x 1.0 g + MTX | Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
|
|
| OG001 | Rituximab 2 x 0.5 g + MTX | Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
| OG002 | Rituximab 2 x 1.0 g + MTX | Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
|
|
| OG002 | Rituximab 2 x 1.0 g + MTX | Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
|
|
| OG002 | Rituximab 2 x 1.0 g + MTX | Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
|
|
| OG002 | Rituximab 2 x 1.0 g + MTX | Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
|
|
| OG002 | Rituximab 2 x 1.0 g + MTX | Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
|
|
| OG002 | Rituximab 2 x 1.0 g + MTX | Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
|
|
| OG002 | Rituximab 2 x 1.0 g + MTX | Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
|
|
| OG002 | Rituximab 2 x 1.0 g + MTX | Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
|
|
| OG002 | Rituximab 2 x 1.0 g + MTX | Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
|
|
Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
| OG002 | Rituximab 2 x 1.0 g + MTX | Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
|
|
| OG001 | Rituximab 2 x 0.5 g + MTX | Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
| OG002 | Rituximab 2 x 1.0 g + MTX | Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
|
|
| OG001 | Rituximab 2 x 0.5 g + MTX | Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
| OG002 | Rituximab 2 x 1.0 g + MTX | Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
|
|
| OG001 | Rituximab 2 x 0.5 g + MTX | Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
| OG002 | Rituximab 2 x 1.0 g + MTX | Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
|
|
| OG001 | Rituximab 2 x 0.5 g + MTX | Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
| OG002 | Rituximab 2 x 1.0 g + MTX | Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
|
|
| OG001 |
| Rituximab 2 x 0.5 g + MTX |
Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
| OG002 | Rituximab 2 x 1.0 g + MTX | Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
|
|
| OG001 | Rituximab 2 x 0.5 g + MTX | Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
| OG002 | Rituximab 2 x 1.0 g + MTX | Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
|
|
| OG001 | Rituximab 2 x 0.5 g + MTX | Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
| OG002 | Rituximab 2 x 1.0 g + MTX | Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study. All participants entered a 48-week safety follow-up (SFU) period following the treatment period. |
|
|
|
|
|