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This randomized, double-blind, parallel-group study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in combination with methotrexate versus RoActemra/Actemra monotherapy in patients with rheumatoid arthritis and an inadequate response to methotrexate. All patients will receive RoActemra/Actemra 8 mg/kg intravenously (iv) every 4 weeks plus oral methotrexate for 16 weeks. Patients achieving low disease activity at Week 16 will be randomized to receive a further 12 weeks of RoActemra/Actemra treatment plus either methotrexate or placebo. Anticipated time on study treatment is 28 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methotrexate | Drug | orally, Week 1 - 16 |
| |
| methotrexate |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Disease Activity Score Based on 28-Joint Count (DAS28) From Week 16 to Week 28 | The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (erythrocyte sedimentation rate [ESR] in millimeters per hour [mm/hr]), and general health status (participant global assessment of disease activity using visual analog scale [VAS], range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. | Baseline, Week 16, and Week 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With DAS28 Score Less Than (<) 2.6 at Week 28 | The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores indicate worsening. DAS28 <2.6 equals (=) remission. |
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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 |
|---|---|---|---|---|---|---|
| Albacete | Albacete | 02006 | Spain | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Tocilizumab (TCZ) Plus (+) Methotrexate (Not Randomized) | Participants received TCZ 8 milligrams per kilogram (mg/kg; maximum 800 mg) via intravenous (IV) infusion every 4 weeks (q4w) through Week 24 (total of 7 infusions). Participants also received methotrexate (MTX) capsules orally, at a stable dose (10, 15, 17.5, or 20 mg, no maximum dose was defined) weekly from Week 1 through 16. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
orally, Week 17-28 |
|
| placebo | Drug | methotrexate placebo orally, Week 17-28 |
|
| tocilizumab [RoActemra/Actemra] | Drug | 8 mg/kg iv every 4 weeks, 28 weeks |
|
| Week 28 |
| Percentage of Participants With Clinical Disease Activity Index (CDAI) <2.8 at Week 28 | CDAI is the sum of tender and swollen joint count based on 28 joints and the participant and physician global disease assessment (VAS 0-10 centimeters [cm]). CDAI total score 0-76; higher scores = greater affect due to disease activity. CDAI <2.8 = clinical remission. | Week 28 |
| Percentage of Participants With Simplified Disease Activity Index (SDAI) <3.3 at Week 28 | SDAI is calculated by a simple numerical sum of tender and swollen joint count (based on a 28-joint assessment), participant and physician global assessment of disease activity (VAS 0-10 cm), and level of C-reactive protein in milligram per deciliter (mg/dL). SDAI total score 0-86; higher scores = greater affect due to disease activity. SDAI <3.3 = clinical remission. | 28 weeks |
| Change in the Health Assessment Questionnaire Disability Index (HAQ-DI) From Week 16 to Week 28 | HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. | Week 16 and Week 28 |
| Change in the Quality of Life Questionnaire (Short Form-12 [SF-12]) From Week 16 to Week 28 in Mental Health | Quality of life questionnaire (SF-12) scores were computed using the scores of 12 questions and ranged from 0 to 100, where a 0 score indicated the lowest level of health measured by the scales and 100 indicated the highest level of health. A negative change from baseline indicated decline in health and higher scores indicated improvement in health. | Week 16 and Week 28 |
| Change in the Quality of Life Questionnaire (SF-12) From Week 16 to Week 28 in Physical Health | Quality of life questionnaire (SF-12) scores were computed using the scores of 12 questions and ranged from 0 to 100, where a 0 score indicated the lowest level of health measured by the scales and 100 indicated the highest level of health. A negative change from baseline indicated a worsening of quality of life. | Week 16 and Week 28 |
| Change From Week 16 to Week 28 in Global Assessment of Disease Activity as Assessed With the Visual Analogue Scale (VAS) Performed by Participant | Participants were asked to rate their global assessment of disease activity on a scale ranging from 0=very good to 100=very bad. The scale was represented by a line with 0 at the left edge and 100 at the right edge. The participant was asked to mark the line corresponding to the assessment of their disease activity. The distance from the left edge was measured in mm. | Week 16 and Week 28 |
| Change From Week 16 to Week 28 in Global Assessment of Disease Activity Assessed Using the VAS Performed by the Investigator | Participants were asked to rate their global assessment of disease activity on a scale ranging from 0=very good to 100=very bad. The scale was represented by a line with 0 at the left edge and 100 at the right edge. The participant was asked to mark the line corresponding to the assessment of their disease activity. The distance from the left edge was measured in mm. | Week 16 and Week 28 |
| Orihuela |
| Alicante |
| 03314 |
| Spain |
| Torrevieja | Alicante | 03186 | Spain |
| Villajoyosa | Alicante | 03570 | Spain |
| Badajoz | Badajoz | 06080 | Spain |
| Mérida | Badajoz | 06800 | Spain |
| Menorca | Balearic Islands | 07701 | Spain |
| Badalona | Barcelona | 08915 | Spain |
| Barcelona | Barcelona | 08003 | Spain |
| Barcelona | Barcelona | 08025 | Spain |
| Barcelona | Barcelona | 08035 | Spain |
| Barcelona | Barcelona | 08036 | Spain |
| Barcelona | Barcelona | 08907 | Spain |
| Granollers | Barcelona | 08402 | Spain |
| Terrassa | Barcelona | 08221 | Spain |
| Cáceres | Caceres | 10310 | Spain |
| Cadiz | Cadiz | 11009 | Spain |
| Torrelavega | Cantabria | 39300 | Spain |
| Villarreal | Castellon | 12540 | Spain |
| Córdoba | Cordoba | 14004 | Spain |
| Granada | Granada | 18003 | Spain |
| Granada | Granada | 18014 | Spain |
| Guadalajara | Guadalajara | 19002 | Spain |
| A Coruña | La Coruña | 15006 | Spain |
| Santiago de Compostela | La Coruña | 15706 | Spain |
| Las Palmas de Gran Canaria | Las Palmas | 35020 | Spain |
| León | Leon | 24071 | Spain |
| Lugo | Lugo | 27004 | Spain |
| Alcalá de Henares | Madrid | 28805 | Spain |
| Fuenlabrada | Madrid | 28942 | Spain |
| Madrid | Madrid | 28007 | Spain |
| Madrid | Madrid | 28031 | Spain |
| Madrid | Madrid | 28034 | Spain |
| Madrid | Madrid | 28040 | Spain |
| Madrid | Madrid | 28041 | Spain |
| Madrid | Madrid | 28046 | Spain |
| Madrid | Madrid | 28905 | Spain |
| Valdemoro | Madrid | 28342 | Spain |
| Málaga | Malaga | 29009 | Spain |
| Cartagena | Murcia | 30203 | Spain |
| El Palmar | Murcia | 30120 | Spain |
| Vigo | Pontevedra | 36214 | Spain |
| Salamanca | Salamanca | 37007 | Spain |
| Seville | Sevilla | 41009 | Spain |
| Seville | Sevilla | 41013 | Spain |
| Santa Cruz de Tenerife | Tenerife | 38010 | Spain |
| Toledo | Toledo | 45004 | Spain |
| Manises | Valencia | 46940 | Spain |
| Valencia | Valencia | 46010 | Spain |
| Valencia | Valencia | 46017 | Spain |
| Valenica | Valencia | 46009 | Spain |
| Barakaldo | Vizcaya | 48903 | Spain |
| Bilbao | Vizcaya | 48013 | Spain |
| Galdakao | Vizcaya | 48960 | Spain |
| FG001 | TCZ + MTX (Randomized) | Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w through Week 24 (total of 7 infusions). Participants also received MTX capsules, orally, at a stable dose (10, 15, 17.5, or 20 mg/week, but no maximum dose was defined), weekly, from Weeks 1 through 24. |
| FG002 | TCZ + Placebo (Randomized) | Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w through Week 24 (total of 7 infusions). Participants also received MTX capsules, orally, at stable dose (10, 15, 17.5, or 20 mg per week, but no maximum dose was defined) weekly, from Weeks 1 through 16 followed by matching placebo capsules, orally, weekly through Week 24. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All treated population
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| ID | Title | Description |
|---|---|---|
| BG000 | TCZ + MTX (Not Randomized) | Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w through Week 24 (total of 7 infusions). Participants also received MTX capsules orally, at a stable dose (10, 15, 17.5, or 20 mg, no maximum dose was defined) weekly from Week 1 through 16. |
| BG001 | TCZ + MTX (Randomized) | Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w through Week 24 (total of 7 infusions). Participants also received MTX capsules, orally, at a stable dose (10, 15, 17.5, or 20 mg/week, but no maximum dose was defined), weekly, from Weeks 1 through 24. |
| BG002 | TCZ + Placebo (Randomized) | Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w through Week 24 (total of 7 infusions). Participants also received MTX capsules, orally, at stable dose (10, 15, 17.5, or 20 mg per week, but no maximum dose was defined) weekly, from Weeks 1 through 16 followed by matching placebo capsules, orally, weekly through Week 24. |
| 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 | Change in Disease Activity Score Based on 28-Joint Count (DAS28) From Week 16 to Week 28 | The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (erythrocyte sedimentation rate [ESR] in millimeters per hour [mm/hr]), and general health status (participant global assessment of disease activity using visual analog scale [VAS], range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. | Intent-to-treat (ITT) population: all randomized participants who received at least one dose of study medication and who had at least one efficacy measurement performed. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 16, and Week 28 |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With DAS28 Score Less Than (<) 2.6 at Week 28 | The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores indicate worsening. DAS28 <2.6 equals (=) remission. | ITT Population; only participants with Week 28 DAS28 values were included in the analysis. | Posted | Number | percentage of participants | Week 28 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinical Disease Activity Index (CDAI) <2.8 at Week 28 | CDAI is the sum of tender and swollen joint count based on 28 joints and the participant and physician global disease assessment (VAS 0-10 centimeters [cm]). CDAI total score 0-76; higher scores = greater affect due to disease activity. CDAI <2.8 = clinical remission. | ITT Population; only participants with CDAI scores at Weeks 28 were included in the analysis. | Posted | Number | percentage of participants | Week 28 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Simplified Disease Activity Index (SDAI) <3.3 at Week 28 | SDAI is calculated by a simple numerical sum of tender and swollen joint count (based on a 28-joint assessment), participant and physician global assessment of disease activity (VAS 0-10 cm), and level of C-reactive protein in milligram per deciliter (mg/dL). SDAI total score 0-86; higher scores = greater affect due to disease activity. SDAI <3.3 = clinical remission. | ITT Population; only participants with SDAI scores at Week 28 were included in the analysis. | Posted | Number | percentage of participants | 28 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in the Health Assessment Questionnaire Disability Index (HAQ-DI) From Week 16 to Week 28 | HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0 = no difficulty; 1 = some difficulty; 2 = much difficulty; 3 = unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. | ITT Population; only participants with non missing values were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Week 16 and Week 28 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in the Quality of Life Questionnaire (Short Form-12 [SF-12]) From Week 16 to Week 28 in Mental Health | Quality of life questionnaire (SF-12) scores were computed using the scores of 12 questions and ranged from 0 to 100, where a 0 score indicated the lowest level of health measured by the scales and 100 indicated the highest level of health. A negative change from baseline indicated decline in health and higher scores indicated improvement in health. | ITT Population; only participants with non missing values were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Week 16 and Week 28 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in the Quality of Life Questionnaire (SF-12) From Week 16 to Week 28 in Physical Health | Quality of life questionnaire (SF-12) scores were computed using the scores of 12 questions and ranged from 0 to 100, where a 0 score indicated the lowest level of health measured by the scales and 100 indicated the highest level of health. A negative change from baseline indicated a worsening of quality of life. | ITT Population; only participants with non missing data were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Week 16 and Week 28 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Week 16 to Week 28 in Global Assessment of Disease Activity as Assessed With the Visual Analogue Scale (VAS) Performed by Participant | Participants were asked to rate their global assessment of disease activity on a scale ranging from 0=very good to 100=very bad. The scale was represented by a line with 0 at the left edge and 100 at the right edge. The participant was asked to mark the line corresponding to the assessment of their disease activity. The distance from the left edge was measured in mm. | ITT Population; only participants with non missing values were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Week 16 and Week 28 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Week 16 to Week 28 in Global Assessment of Disease Activity Assessed Using the VAS Performed by the Investigator | Participants were asked to rate their global assessment of disease activity on a scale ranging from 0=very good to 100=very bad. The scale was represented by a line with 0 at the left edge and 100 at the right edge. The participant was asked to mark the line corresponding to the assessment of their disease activity. The distance from the left edge was measured in mm. | ITT Population; only participants with non missing values were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Week 16 and Week 28 |
|
|
From Day 1 up to Week 36
The data were planned per the protocol to be reported separately for pre-randomization period and post-randomization period.
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 | TCZ + MTX (Not Randomized) | Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w through Week 24 (total of 7 infusions). Participants also received MTX capsules orally, at a stable dose (10, 15, 17.5, or 20 mg, no maximum dose was defined) weekly from Week 1 through 16. | 11 | 96 | 28 | 96 | ||
| EG001 | TCZ + MTX (Pre-randomization) | Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w up to Week 16 (total of 4 infusions). Participants also received MTX capsules, orally at a stable dose (10, 15, 17.5, or 20 mg/week but no maximum dose was set) weekly, up to Week 16. Participants with a response were randomized to receive TCZ and MTX in the second part of the study. Response was defined as participants having DAS28 score less than or equal to (<=)3.2. | 0 | 83 | 20 | 83 | ||
| EG002 | TCZ + Placebo (Pre-randomization) | Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w up to Week 16 (total of 4 infusions). Participants also received MTX capsules, orally at a stable dose (10, 15, 17.5, or 20 mg/week but no maximum dose was set) weekly, up to Week 16. Participants with a response were randomized to receive TCZ and matching MTX placebo in the second part of the study. Response was defined as participants having DAS28 score <=3.2. | 1 | 82 | 24 | 82 | ||
| EG003 | TCZ + MTX (Post-randomization) | TCZ 8 mg/kg (maximum 800 mg) q4w via IV infusion up to Week 16 (total of 4 infusions). Participants also received MTX capsules, orally, at a stable dose (10, 15, 17.5, or 20 mg/week but no maximum dose was set) weekly, up to Week 16. Participants with a response were randomized to receive 3 additional IV infusions of TCZ 8 mg/kg between Week 16 and Week 24 and MTX capsules, orally, at a stable dose (10, 15, 17.5, or 20 mg per week, but no maximum dose was set), weekly through Week 24. Response was defined as participants having DAS28 score <=3.2. | 1 | 83 | 8 | 83 | ||
| EG004 | TCZ + Placebo (Post-randomization) | TCZ 8 mg/kg (maximum 800 mg) q4w via IV infusion up to Week 16 (total of 4 infusions). Participants also received MTX capsules, orally, at a stable dose (10, 15, 17.5, or 20 mg/week but no maximum dose was set) weekly, up to Week 16. Participants with a response were randomized to receive 3 additional IV infusions of TCZ 8 mg/kg between Week 16 and Week 24 and matching placebo MTX capsules, orally, at a stable dose (10, 15, 17.5, or 20 mg per week, but no maximum dose was set), weekly through Week 24. Response was defined as participants having DAS28 score <=3.2. | 4 | 82 | 4 | 82 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Bursitis infective | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Endocarditis bacterial | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Staphylococcal skin infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Salpingitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Lupus-like syndrome | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (17.0) | 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 | Hoffmann-LaRoche | 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 |
|---|---|
| D008727 | Methotrexate |
| C502936 | tocilizumab |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
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