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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-005525-11 |
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The study was terminated early because of a related decision to stop the development of ocrelizumab in rheumatoid arthritis.
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This 2 part study will investigate the safety, tolerability and efficacy of MabT hera in combination with RoActemra in patients with active rheumatoid arthritis despite a stable dose of methotrexate. In Part 1 of the study, patients will be randomized to receive either MabThera 0.5g iv or placebo on days 1 and 15, follo wed by RoActemra at one of the ascending doses between 2mg/kg and 8mg/kg at week s 4, 8 and 12 (MabThera arm) or 8mg/kg (placebo arm). In Part 2, additional pati ents will be randomized to one of 2 groups to receive MabThera 0.5g on days 1 an d 15 followed by the selected dose (from Part 1)of RoActemra at weeks 4, 8 and 1 2, or placebo on days 1 and 15 followed by RoActemra 8mg/kg at weeks 4,8 and 12.
All patients will then be eligible to receive extension treatment withRoActemra every 4 weeks. The anticipated time on study treatment is 12 months, and the tar get sample size is <100 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | iv on days 1 and 15 (Parts 1 and 2) |
| |
| rituximab [MabThera/Rituxan] |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Low Disease Activity (LDA) at Week 16 Assessed Using Disease Activity Score Based on 28 Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) | The Disease Activity Score based on 28 joint count (DAS28) and Erythrocyte Sedimentation Rate (ESR), is a measure of the participant's disease activity. It is based on the Tender Joint Count (TJC [28 joints]), Swollen Joint Count (SJC [28 joints]), participant's global assessment of disease activity (PtGA) Visual Analog Scale (VAS) in millimeters (mm), and ESR in millimeters per hour (mm/hour). DAS28-ESR scores range from 0 - 10. Definition of LDA was based on DAS28-ESR scores. To achieve LDA the DAS28-ESR had to be (less than or equal to) ≤ 3.2. DAS28-ESR equals (=) (0.56 times (*) (square root)√ TJC plus (+) (0.28 * √ SJC + (0.70 * ln(ESR))+(0.014 * (Global Health) GH) Where: TJC = based on 28 joints SJC = based on 28 joints ESR = erythrocyte sedimentation rate in mm/hour GH = participant's global assessment of disease activity ln = natural log | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Remission at Week 16 Assessed Using DAS28-ESR | The DAS28-ESR score is a measure of the participant's disease activity. It is based on the TJC (28 joints), SJC (28 joints), participant's global assessment of disease activity (mm), and ESR (mm/hour). DAS28-ESR is expressed on a unit on a scale with the minimum score=0 (best) to maximum score=10 (worst). Remission was defined as DAS28-ESR less than (<) 2.6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Le Kremlin-Bicêtre | 94275 | France | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo + Tocilizumab (TCZ) 8 Milligrams Per Kilogram (mg/kg) | Participants received placebo intravenously (iv) on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period |
|
Not provided
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| Drug |
0.5g iv on days 1 and 15 (Parts 1 and 2) |
|
| tocilizumab [RoActemra/Actemra] | Drug | 2mg/kg-8mg/kg iv in Part 1 and selected dose in Part 2, on weeks 4, 8 and 12---Arm 1\n8mg/kg iv on weeks 4,8 and 12 (Parts 1 and 2)--- Arm 2 |
|
| Week 16 |
| Percentage of Participants by European League Against Rheumatism (EULAR) Response Category at Week 16 | DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline (greater than) >1.2 with DAS28 ≤3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or DAS28-ESR >5.1 or change from baseline >0.6 to ≤1.2 with DAS28 ≤5.1; nonresponders: change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with DAS28 >5.1. | Week 16 |
| Change From Baseline in DAS28-ESR | The DAS28-ESR score is a measure of the participant's disease activity. It is based on the TJC (28 joints), SJC (28 joints), participant's global assessment of disease activity (mm), and ESR (mm/hour). DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). DAS28-ESR scores were calculated as follows: DAS28-ESR = (0.56 * √TJC)+(0.28 * √SJC)+(0.70 * ln(ESR))+(0.014 * GH). No imputation used for tender and swollen joint counts, ESR, and patient's global assessment of disease activity VAS. | Weeks 4, 8, 12, 16, 20, 24, 32, 40 and 48 |
| Clinical Disease Activity Index Scores | The Clinical Disease Activity Index (CDAI) score was calculated according to the following formula: CDAI = SJC + TJC + GH/10 + EGA/10 Where: SJC = swollen joint count based on 28 joints; TJC = tender joint count based on 28 joints; GH = Participant's global assessment of disease activity; EGA = evaluator's (physician's) global assessment of disease activity. CDAI scores range from 0-76 and the following cut-off points for different disease activity states have been used: high disease activity >22; moderate disease activity >10 and ≤22; LDA >2.8 and ≤10; and remission ≤ 2.8. No imputation used for TJC, SJC, Patient's Global Assessment of Disease Activity VAS and Physicians global assessment of disease activity VAS. | Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40 and 48 |
| Simplified Disease Activity Index (SDAI) Scores | The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), Participant and Physician assessed global disease activity (assessed on 0-100 mm VAS; higher scores = greater affection due to disease activity), and ESR (mm/hour). SDAI total score ranged from 0 to 86. Higher scores indicated greater disease activity. | Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48 |
| Change From Baseline to Week 48 in SJC and TJC | An assessment of 28 joints for swelling and tenderness will be made. Joints will be assessed and classified as swollen (1)/not swollen (0) and tender(1)/not tender (0) by pressure and joint manipulation on physical examination. Joint prosthesis, arthrodesis or fused joints were not taken into consideration for swelling or tenderness. The 28 joints assessed comprise shoulders (2 joints), elbows (2 joints), wrists (2 joints), metacarpophalangeal joints on digits 1-5 (10 joints), interphalangeal on digit 1 (2 joints), proximal interphalangeal joints on digits 2-5 (8 joints), and knees (2 joints). | Baseline and Week 48 |
| Change From Baseline to Week 48 in Health Assessment Questionnaire (HAQ) | The Stanford Health Assessment Questionnaire disability index specific for rheumatoid arthritis was completed by the participants for efficacy assessments. | Baseline and Week 48 |
| Change From Baseline to Week 48 in C-Reactive Protein (CRP) | CRP is an acute phase reactant and is a measure of inflammation. | Baseline and Week 48 |
| Change From Baseline to Week 48 in ESR | ESR is an acute phase reactant and is a measure of inflammation. | Baseline and Week 48 |
| Change From Baseline to Week 48 in Physician's Global Assessment of Disease Activity | Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm= maximum disease activity. The physician marked the line according to their assessment and the distance from the left edge was measured. | Baseline and Week 48 |
| Change From Baseline to Week 48 in Participant's Global Assessment of Disease Activity | Participant's Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm = maximum disease activity. The participant marked the line according to their assessment and the distance from the left edge was measured. | Baseline and Week 48 |
| Change From Baseline to Week 48 in Participant's Assessment of Pain | Participant's Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no pain and 100 mm = maximum pain. The participant marked the line according to their assessment and the distance from the left edge was measured. | Baseline and Week 48 |
| Montpellier |
| 34295 |
| France |
| Paris | 75679 | France |
| Strasbourg | 67098 | France |
| Berlin | 10117 | Germany |
| Berlin | 14059 | Germany |
| Cologne | 50924 | Germany |
| Heidelberg | 69120 | Germany |
| Würzburg | 97080 | Germany |
| Athens | 15121 | Greece |
| Thessaloniki | 54636 | Greece |
| Amsterdam | 1105 AZ | Netherlands |
| Leiden | 2333 ZA | Netherlands |
| Bytom | 41-902 | Poland |
| Lublin | 20-607 | Poland |
| Poznan | 60-218 | Poland |
| Santander | Cantabria | 39008 | Spain |
| Santiago de Compostela | La Coruña | 15706 | Spain |
| Madrid | Madrid | 28007 | Spain |
| Seville | Sevilla | 41009 | Spain |
| Bern | 3010 | Switzerland |
| Lausanne | 1011 | Switzerland |
| Newcastle upon Tyne | NE1 4LP | United Kingdom |
| Southampton | SO16 6YD | United Kingdom |
| FG001 | Rituximab (0.5 Grams [g]) + TCZ (2 mg/kg) | Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid. |
| FG002 | Rituximab (0.5 g) + TCZ (4 mg/kg) | Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Safety Follow-Up |
|
|
| Extended Safety Follow-Up |
|
|
Safety population: All participants who were randomized and received any part of an infusion of study medication; participants who received the incorrect therapy from that intended were summarized in the group according to the therapy actually received for the majority of the time through Week 48.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo + TCZ (8 mg/kg) | Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid. |
| BG001 | Rituximab (0.5 g) + TCZ (2 mg/kg) | Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid. |
| BG002 | Rituximab (0.5 g) + TCZ (4 mg/kg) | Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid. |
| 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 Achieving Low Disease Activity (LDA) at Week 16 Assessed Using Disease Activity Score Based on 28 Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) | The Disease Activity Score based on 28 joint count (DAS28) and Erythrocyte Sedimentation Rate (ESR), is a measure of the participant's disease activity. It is based on the Tender Joint Count (TJC [28 joints]), Swollen Joint Count (SJC [28 joints]), participant's global assessment of disease activity (PtGA) Visual Analog Scale (VAS) in millimeters (mm), and ESR in millimeters per hour (mm/hour). DAS28-ESR scores range from 0 - 10. Definition of LDA was based on DAS28-ESR scores. To achieve LDA the DAS28-ESR had to be (less than or equal to) ≤ 3.2. DAS28-ESR equals (=) (0.56 times (*) (square root)√ TJC plus (+) (0.28 * √ SJC + (0.70 * ln(ESR))+(0.014 * (Global Health) GH) Where: TJC = based on 28 joints SJC = based on 28 joints ESR = erythrocyte sedimentation rate in mm/hour GH = participant's global assessment of disease activity ln = natural log | Intent-to-Treat (ITT) Population: all randomized participants who received any part of an infusion of study medication. Last observation carried forward (LOCF) used for TJC and SJC, ESR and PtGA. If DAS28-ESR value was missing LDA was missing. | Posted | Number | percentage of participants | Week 16 |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Remission at Week 16 Assessed Using DAS28-ESR | The DAS28-ESR score is a measure of the participant's disease activity. It is based on the TJC (28 joints), SJC (28 joints), participant's global assessment of disease activity (mm), and ESR (mm/hour). DAS28-ESR is expressed on a unit on a scale with the minimum score=0 (best) to maximum score=10 (worst). Remission was defined as DAS28-ESR less than (<) 2.6 | ITT Population; LOCF used for TJC, ESR, and PtGA. If the DAS28-ESR value was missing then remission or LDA was missing. | Posted | Number | percentage of participants | Week 16 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants by European League Against Rheumatism (EULAR) Response Category at Week 16 | DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline (greater than) >1.2 with DAS28 ≤3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or DAS28-ESR >5.1 or change from baseline >0.6 to ≤1.2 with DAS28 ≤5.1; nonresponders: change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with DAS28 >5.1. | ITT Population; No imputation used for TJC, SJC, ESR, and PtGA. EULAR response was set to missing when the DAS28 score was missing. | Posted | Number | percentage of participants | Week 16 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in DAS28-ESR | The DAS28-ESR score is a measure of the participant's disease activity. It is based on the TJC (28 joints), SJC (28 joints), participant's global assessment of disease activity (mm), and ESR (mm/hour). DAS28-ESR is expressed as a score on a scale with the minimum score=0 (best) to maximum score=10 (worst). DAS28-ESR scores were calculated as follows: DAS28-ESR = (0.56 * √TJC)+(0.28 * √SJC)+(0.70 * ln(ESR))+(0.014 * GH). No imputation used for tender and swollen joint counts, ESR, and patient's global assessment of disease activity VAS. | ITT Population; number (n) = number of participants analyzed at the specified visit. | Posted | Mean | Standard Deviation | units on a scale | Weeks 4, 8, 12, 16, 20, 24, 32, 40 and 48 |
| |||||||||||||||||||||||||||||||||
| Secondary | Clinical Disease Activity Index Scores | The Clinical Disease Activity Index (CDAI) score was calculated according to the following formula: CDAI = SJC + TJC + GH/10 + EGA/10 Where: SJC = swollen joint count based on 28 joints; TJC = tender joint count based on 28 joints; GH = Participant's global assessment of disease activity; EGA = evaluator's (physician's) global assessment of disease activity. CDAI scores range from 0-76 and the following cut-off points for different disease activity states have been used: high disease activity >22; moderate disease activity >10 and ≤22; LDA >2.8 and ≤10; and remission ≤ 2.8. No imputation used for TJC, SJC, Patient's Global Assessment of Disease Activity VAS and Physicians global assessment of disease activity VAS. | ITT Population; n=number of participants analyzed for the given parameter at the specified timepoint. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40 and 48 |
| |||||||||||||||||||||||||||||||||
| Secondary | Simplified Disease Activity Index (SDAI) Scores | The SDAI is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), Participant and Physician assessed global disease activity (assessed on 0-100 mm VAS; higher scores = greater affection due to disease activity), and ESR (mm/hour). SDAI total score ranged from 0 to 86. Higher scores indicated greater disease activity. | Data were not collected because the study was terminated early. | Posted | Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 48 in SJC and TJC | An assessment of 28 joints for swelling and tenderness will be made. Joints will be assessed and classified as swollen (1)/not swollen (0) and tender(1)/not tender (0) by pressure and joint manipulation on physical examination. Joint prosthesis, arthrodesis or fused joints were not taken into consideration for swelling or tenderness. The 28 joints assessed comprise shoulders (2 joints), elbows (2 joints), wrists (2 joints), metacarpophalangeal joints on digits 1-5 (10 joints), interphalangeal on digit 1 (2 joints), proximal interphalangeal joints on digits 2-5 (8 joints), and knees (2 joints). | Data were not collected because the study was terminated early. | Posted | Baseline and Week 48 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 48 in Health Assessment Questionnaire (HAQ) | The Stanford Health Assessment Questionnaire disability index specific for rheumatoid arthritis was completed by the participants for efficacy assessments. | Data were not collected because the study was terminated early. | Posted | Baseline and Week 48 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 48 in C-Reactive Protein (CRP) | CRP is an acute phase reactant and is a measure of inflammation. | Data were not collected because the study was terminated early. | Posted | Baseline and Week 48 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 48 in ESR | ESR is an acute phase reactant and is a measure of inflammation. | Data were not collected because the study was terminated early. | Posted | Baseline and Week 48 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 48 in Physician's Global Assessment of Disease Activity | Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm= maximum disease activity. The physician marked the line according to their assessment and the distance from the left edge was measured. | Data were not collected because the study was terminated early. | Posted | Baseline and Week 48 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 48 in Participant's Global Assessment of Disease Activity | Participant's Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm = maximum disease activity. The participant marked the line according to their assessment and the distance from the left edge was measured. | Data were not collected because the study was terminated early. | Posted | Baseline and Week 48 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 48 in Participant's Assessment of Pain | Participant's Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no pain and 100 mm = maximum pain. The participant marked the line according to their assessment and the distance from the left edge was measured. | Data were not collected because the study was terminated early. | Posted | Baseline and Week 48 |
|
Adverse Events were recorded throughout the study from the date of first study drug administration until 48 weeks of treatment period and for those in the Safety follow up population until the end of follow up period.
Participants who received the incorrect therapy from that intended were summarized in the group according to the therapy actually received for the majority of the time through Week 48. 1 participant each from Placebo + TCZ (8 mg/kg) and Rituximab (0.5 g) + TCZ (2 mg/kg) groups was included in Rituximab (0.5 g) + TCZ (4 mg/kg) group.
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 + TCZ (8 mg/kg) | Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid. | 1 | 3 | 3 | 3 | ||
| EG001 | Rituximab (0.5 g) + TCZ (2 mg/kg) | Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid. | 2 | 9 | 9 | 9 | ||
| EG002 | Rituximab (0.5 g) + TCZ (4 mg/kg) | Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid. | 3 | 12 | 11 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | General disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Infusion related reaction | General disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Large intestinal ulcer haemorrhage | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Injury, poisoning and procedural complications | MedDRA (13.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Acute tonsillitis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Dermatitis infected | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Infected bites | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Infusion related reaction | General disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Ligamentitis | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Tenosynovitis stenosans | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Intertrigo | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Rosacea | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Essential tremor | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Occipital neuralgia | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Allergic bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Corneal erosion | Eye disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Presbyopia | Eye disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (13.1) | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Genital ulceration | Reproductive system and breast disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Seasonal Allergy | Immune system disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Asthma | Immune system disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Occipital Neuralgia (left) | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Occipital Neuralgia (right) | Nervous system disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Aphthous stomatitis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Anxiety Disorder | Psychiatric disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Rash | General disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Cervix Disorder | General disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Tooth Ache | General disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Pyrexia | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Wound Infection | Infections and infestations | MedDRA (13.1) | Non-systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | 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 after the first publication or presentation that involves the overall study. 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 | Hoffmann- LaRoche | 1-800-821-8590 | 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 |
|---|---|
| D000069283 | Rituximab |
| C502936 | tocilizumab |
| ID | Term |
|---|---|
| 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
| Male |
|
| OG002 | Rituximab (0.5 g) + TCZ (4 mg/kg) | Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid. |
|
|
| OG002 | Rituximab (0.5 g) + TCZ (4 mg/kg) | Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid. |
|
|
| OG002 | Rituximab (0.5 g) + TCZ (4 mg/kg) | Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid. |
|
|
| OG002 | Rituximab (0.5 g) + TCZ (4 mg/kg) | Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid. |
|
|
| Rituximab (0.5 g) + TCZ (4 mg/kg) |
Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid. |
|
| OG002 | Rituximab (0.5 g) + TCZ (4 mg/kg) | Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid. |
|
|
|
|
Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid. |
|
Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid. |
|
Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
|