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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-011105-17 |
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This single arm study will assess the effect of tocilizumab + DMARDs (Disease Modifying Anti-Rheumatic Drugs)on improvement of anemia and fatigue in patients with moderate to severe active rheumatoid arthritis. Eligible patients who have had an inadequate response to DMARDs will receive tocilizumab 8mg/kg iv every 4 weeks in combination with standard DMARDs, for 6 months. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tocilizumab [RoActemra/Actemra] | Drug | 8mg/kg iv every 4 weeks for 6 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of Anemia at Week 4 Assessed as Change From Baseline in Hemoglobin | Hemoglobin levels were measured as grams/deciliter (g/dL). | Week 4 |
| Improvement in Fatigue at Week 4 Assessed as Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scores | The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). Clinically relevant improvement is defined as a greater than or equal to (≥)5-point change from Baseline. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Hemoglobin Levels During the Study | Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24 | |
| Improvement of Anemia Assessed as Change From Baseline in Hemoglobin | Improvement of anemia was evaluated as change in hemoglobin levels from baseline. |
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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 |
|---|---|---|---|---|---|---|
| Ospedale Perrino; Medicina Interna - Divisione di Reumatologia | Brindisi | Apulia | 72100 | Italy | ||
| Presidio Ospedaliero Valle D'itria; Divisione Di Nefrologia |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tocilizumab 8 mg/kg | Participants received tocilizumab 8 milligrams per kilogram (mg/kg) (maximum dose 800 mg) intravenously (IV) once every 4 weeks for a total of 6 infusions. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Standard DMARDs (Disease Modifying Anti Rheumatic Drugs) |
| Drug |
As prescribed |
|
| Weeks 2, 4, 8, 12, 16, 20, and 24 |
| FACIT-F Scores | The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). Clinically relevant improvement is defined as a ≥5-point change from Baseline. | Baseline, Weeks 2, 4, 8,12, 16, 20 and 24 |
| Improvement of Fatigue Assessed as Change From Baseline in FACIT-F Scores | The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). Clinically relevant improvement is defined as a ≥5-point change from Baseline. | Weeks 2, 4, 8, 12, 16, 20 and 24 |
| Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50% or 70% Improvement | The ACR response rates ACR20, ACR50, and ACR70 were defined as ≥20%, ≥50% and ≥ 70% improvement, respectively, in: swollen joint count (SJC) (66 joints) and tender joint count (TJC) (68 joints) and 3 of the 5 remaining ACR parameters: Patient assessment of pain; Patient Global Assessment of Disease Activity; Investigator Global Assessment of Disease Activity; participant self-rated assessment of disability measured by the Health Assessment Questionnaire Disability Index (HAQ-DI); and acute phase response (erythrocyte sedimentation rate [ESR] or C-reactive protein [CRP]). | Week 24 |
| Percent Change From Baseline to Week 24 in TJC | Sixty-eight (68) joints were assessed at each visit for tenderness; joints were assessed and classified as tender/not tender. Tender joint count 68 (TJC-68) was calculated as the number of tender joints from 68 joints; the number of tender joints was summed (maximum score 68). Calculated values were used for the analysis. A negative score indicated improvement. | Week 24 |
| Percent Change From Baseline to Week 24 in SJC | Sixty-six (66) joints were assessed at each visit for swelling; joints were assessed and classified as swollen/not swollen. Swollen joint count 66 (SJC-66) was calculated as the number of swollen joints from 66 joints; the number of swollen joints was summed (maximum score 66). Calculated values were used for the analysis. A negative score indicated improvement. | Week 24 |
| Percent Change From Baseline to Week 24 in Patient Global Assessment of Pain | The participant's assessment of their current level of pain was displayed on a 100-millimeter (mm) horizontal visual analog scale (VAS). The left-hand extreme of the line was described as "no pain" and the right-hand as "unbearable pain". The participant was asked to mark the line that corresponded to their current level of pain; the distance from the left edge was recorded. | Week 24 |
| Percent Change From Baseline to Week 24 in Patient's Global Assessment of Disease Activity | The participant's overall assessment of their current disease activity was displayed on a 100-mm horizontal VAS. The left-hand extreme of the line was described as "no disease activity" (symptom free and no arthritis symptoms) and the right-hand extreme as "maximum disease activity" (maximum arthritis disease activity). Participants were asked to assess their current level of disease activity and mark the line; the distance from the left edge was recorded. | Week 24 |
| Percent Change From Baseline to Week 24 in Investigator's Global Assessment of Disease Activity | The physician's assessment of the participant's current disease activity was displayed on a 100-mm horizontal VAS. The left-hand extreme of the line was described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme was considered "maximum disease activity". The physician's global assessment of disease activity was completed by the Efficacy Assessor who could or could not be a physician. The assessor was asked to mark the line corresponding to their assessment of the participant's present level of disease activity; the distance from the left edge was recorded. | Week 24 |
| Percent Change From Baseline to Week 24 in HAQ-DI | HAQ-DI includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Overall score was computed as the sum of the domain scores and divided by the number of domains answered. Total possible score range was 0-3 where 0 (equals)=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. | Week 24 |
| Percent Change From Baseline to Week 24 in High-Sensitivity CRP (Hs-CRP) | hs-CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). hsCRP is measured in milligrams per liter (mg/L). | Week 24 |
| Percent Change From Baseline to Week 24 in ESR | ESR is a blood test used to monitor therapy in inflammatory diseases such as RA and reflects acute phase reactant levels. ESR is measured in mm per hour (mm/hr); active disease in RA is defined by an ESR greater than 30 mm/hr. | Week 24 |
| Percentage of Participants With a Response at Week 24 by European League Against Rheumatism (EULAR) Category | Disease response was assessed using EULAR Disease Activity Score Based on 28-Joint Count (DAS28) categories of Good, Moderate, or No Response. Good response was defined as a DAS28 score of less than (<)3.2 and improvement from baseline of >1.2; Moderate response was defined as a DAS28 score of 3.2-5.1 and improvement from baseline of 1.2-0.6 or a DAS28 score of >5.1 and improvement from baseline of >1.2; No response was defined as a DAS28 score of >5.1 and improvement from baseline of <1.2. Participants who discontinued prematurely were identified as non-responders. | Week 24 |
| Percentage of Participants With a Response at Week 24 by DAS28 Category | DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the ESR (mm/hr) and patient's global assessment of disease activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2=low disease activity, DAS28 >5.1=high disease activity and DAS <2.6=remission. | Week 24 |
| Percent Change From Baseline to Week 24 in DAS28 Score | DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the ESR (mm/hr) and patient's global assessment of disease activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2=low disease activity, DAS28 >5.1=high disease activity and DAS <2.6=remission. | Week 24 |
| Percentage of Participants With an Improvement of ≥1 g/dL in Hemoglobin | Week 24 |
| Number of Days as Assessed by Short Form-Health and Labour Questionnaire (SF-HLQ) | The SF-HLQ assessed productivity losses related to health problems in individuals with paid or unpaid work and consists of three modules (absenteeism from paid work, production losses without absenteeism from paid work and hindrance in the performance of paid and unpaid work). Any missed working days or number of worked days with reduced efficiency during the last month were reported. | Baseline |
| Change From Baseline to Weeks 12 and 24 in Number of Days as Assessed by SF-HLQ | The SF-HLQ assessed productivity losses related to health problems in individuals with paid or unpaid work and consists of three modules (absenteeism from paid work, production losses without absenteeism from paid work and hindrance in the performance of paid and unpaid work). Any missed working days or number of worked days with reduced efficiency during the last month were reported. | Weeks 12 and 24 |
| Number of Hours as Assessed by SF-HLQ | Number of working hours lost, and number of hours of support in in taking over and performing usual household tasks in the last month: chores done by family members, chores done by other persons receiving no pay, home care, other paid care, total number of unpaid hours, and total number of hours during the last month were reported. | Baseline |
| Change From Baseline to Weeks 12 and 24 in Number of Hours as Assessed by SF-HLQ | Number of working hours lost, and number of hours of support in in taking over and performing usual household tasks in the last month: chores done by family members, chores done by other persons receiving no pay, home care, other paid care, total number of unpaid hours, and total number of hours during the last month were reported. Changes from baseline were only calculated in participants who completed the questionnaire at all times (baseline, Week 12, and Week 24). Negative number indicates improvement. | Baseline |
| SF-HLQ Hindrance Score | Participants were asked if their health problems hindered their paid work on a scale of 1 to 3 (1=no, 2=yes, slightly, 3=yes, very much) and their unpaid work including household work, going shopping, odd jobs, specific activities sharing the household on a scale of 0 to 3 (0=performed without being bothered by healthy problems; 1=performed although bothered by health problems; 2=not performed because of health problems; 3=not performed for reasons other than health problems). The total hindrance score for unpaid work was derived by adding up the item scores. This hindrance score is a measure of the hindrance experienced as a result of health problems during the performance of unpaid work. The minimum score per item for hindrance score was 0, maximum score was 2 (Score of 3 was not considered since the reasons were "other than health problems"). Total score was calculated by adding all 4 items together and ranged from 0 (best possible score) to 8 (worst possible score). | Baseline |
| Change From Baseline to Weeks 12 and 24 SF-HLQ Hindrance Score | Participants were asked if health problems hindered their paid work on a scale of 1 to 3 (1=no, 2=yes, slightly, 3=yes, very much) and their unpaid work including household work, going shopping, odd jobs, specific activities sharing the household on a scale of 0 to 3 (0=performed without being bothered by healthy problems; 1=performed although bothered by health problems; 2=not performed because of health problems; 3=not performed for reasons other than health problems). Hindrance score is a measure of the hindrance experienced as a result of health problems during the performance of unpaid work. The minimum score per item for hindrance score was 0, maximum score was 2 (Score of 3 was not considered since the reasons were "other than health problems"). Total score was calculated by adding all 4 items together and ranged from 0 (best possible score) to 8 (worst possible score). A negative change from baseline indicates improvement. | Baseline |
| Efficiency as Assessed by SF-HLQ | Participants were ask to rate their efficiency in working on a scale of of 0 to 10 (0=very worse, 10=as usual). Overall efficiency score was based on the first 6 items of Question 6, which is a descriptive instrument comprised of 7 items designed to evaluate the specific problems affecting production. These 7 items relate to the effect of health problems on concentration, work pace, the need to be alone, making decisions, postponing and transferring work to others. The participant can choose from 4 possible answers: (almost) never, sometimes, often and (nearly) always. Efficiency score range=6 to 24; higher scores indicate higher impairment. | Baseline |
| Change From Baseline to Weeks 12 and 24 in Efficiency as Assessed by SF-HLQ | Participants were ask to rate their efficiency in working on a scale of of 0 to 10 (0=very worse, 10=as usual). Overall efficiency score was based on the first 6 items of Question 6, which is a descriptive instrument comprised of 7 items designed to evaluate the specific problems affecting production. These 7 items relate to the effect of health problems on concentration, work pace, the need to be alone, making decisions, postponing and transferring work to others. The participant can choose from 4 possible answers: (almost) never, sometimes, often and (nearly) always. Efficiency score range=6 to 24; higher scores indicate higher impairment. Change from baseline was only calculated for participants who completed the questionnaire at all times (baseline, Week 12 and Week 24). A negative change from baseline indicates improvement. | Baseline |
| Martina Franca |
| Apulia |
| 74015 |
| Italy |
| Ospedale Galateo; U.O. Di Reumatologia | San Cesario di Lecce | Apulia | 73016 | Italy |
| Azienda Ospedaliera Rummo; Divisione Di Reumatologia | Benevento | Campania | 82100 | Italy |
| Azienda Ospedaliera A. Cardarelli; Medicina III - Divisione di Reumatologia | Naples | Campania | 80131 | Italy |
| UNIVERSITÀ DI NAPOLI FEDERICO II; Dipartimento di Immunologia Clinica ed Allergologia | Naples | Campania | 80131 | Italy |
| Ospedale M. Scarlato - Asl Sa1; U.O. Di Reumatologia | Scafati | Campania | 84018 | Italy |
| Irccs Fondazione Salvatore Maugeri-Istituto Scientifico Di Telese;U.O. Riabilitazione Reumatologica | Telese Terme | Campania | 82037 | Italy |
| A.O.U Policlinico S. Orsola Malpighi di Bologna U.O di Medicina Interna Borghi - Pad.2 | Bologna | Emilia-Romagna | 40138 | Italy |
| Az. Ospedaliera Univ. di Parma; Medicina Interna e Reumatologia | Parma | Emilia-Romagna | 43100 | Italy |
| Ospedale Guglielmo Da Saliceto Unità Operativa Semplice di Reumatologia e Immunologia | Piacenza | Emilia-Romagna | 29100 | Italy |
| Policlinico Tor Vergata; Divisione Di Reumatologia | Rome | Lazio | 00133 | Italy |
| Ospedale Nuovo Regina Margherita; Divisione di Medicina Interna Reumatologia | Rome | Lazio | 00153 | Italy |
| Ospedale S.Pietro Fatebenefratelli; Divisione di Reumatologia | Rome | Lazio | 00189 | Italy |
| Ospedale Belcolle; Divisione Di Reumatologia | Viterbo | Lazio | 01100 | Italy |
| Ospedale San Paolo; Divisione di Reumatologia | Savona | Liguria | 17100 | Italy |
| ASST PAPA GIOVANNI XXIII; Reumatologia Day Hospital-Torre 2 terzo piano | Bergamo | Lombardy | 24127 | Italy |
| ASST DI MONZA; Reumatologia (Medicina I) | Monza | Lombardy | 20052 | Italy |
| IRCCS Istituto Clinico Humanitas; Immunologia Clinica E Reumatologia | Rozzano | Lombardy | 20089 | Italy |
| Ospedale S. Giovanni Bosco; S.C. A Direzione Uni Ria Di Immunologia Clinica | Turin | Piedmont | 10154 | Italy |
| Ospedale Vittorio Emanuele Ii; U.O. Reumatologia Clinica Medica Condorelli | Catania | Sicily | 95124 | Italy |
| A.U.O. G. Martino- Policlinico Univ. Gazzi; Dept. Di Medicina Interna, Divisione Di Reumatologia | Gazzi | Sicily | 98125 | Italy |
| Arnas Ospedale Civico; Medicina Interna II | Palermo | Sicily | 90127 | Italy |
| Az. Osp. Villa Sofia; Unità Operativa Reumatologia | Palermo | Sicily | 90146 | Italy |
| Ospedali Riuniti Villa Sofia- Cervello X; Divisione Medicina I | Palermo | Sicily | 90146 | Italy |
| Ospedale Di Massa; Divisione Di Reumatologia | Massa | Tuscany | 54100 | Italy |
| Ospedale SS Giovanni e Paolo; Divisione Di Reumatologia | Venezia | Veneto | 30127 | Italy |
| COMPLETED |
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| NOT COMPLETED |
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Intent-to-Treat (ITT) population: all enrolled participants who recieved at least 1 dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tocilizumab 8 mg/kg | Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions. |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
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| 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 | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Mean Hemoglobin Levels During the Study | ITT population; n=number of participants assessed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | g/dL | Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24 |
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| Primary | Improvement of Anemia at Week 4 Assessed as Change From Baseline in Hemoglobin | Hemoglobin levels were measured as grams/deciliter (g/dL). | ITT population | Posted | Mean | Standard Deviation | g/dL | Week 4 |
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| Secondary | Improvement of Anemia Assessed as Change From Baseline in Hemoglobin | Improvement of anemia was evaluated as change in hemoglobin levels from baseline. | ITT population; n=number of participants assessed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | g/dL | Weeks 2, 4, 8, 12, 16, 20, and 24 |
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| Secondary | FACIT-F Scores | The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). Clinically relevant improvement is defined as a ≥5-point change from Baseline. | ITT population; n=number of participants assessed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 2, 4, 8,12, 16, 20 and 24 |
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| Secondary | Improvement of Fatigue Assessed as Change From Baseline in FACIT-F Scores | The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). Clinically relevant improvement is defined as a ≥5-point change from Baseline. | ITT population; n=number of participants assessed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | units on a scale | Weeks 2, 4, 8, 12, 16, 20 and 24 |
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| Secondary | Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%), 50% or 70% Improvement | The ACR response rates ACR20, ACR50, and ACR70 were defined as ≥20%, ≥50% and ≥ 70% improvement, respectively, in: swollen joint count (SJC) (66 joints) and tender joint count (TJC) (68 joints) and 3 of the 5 remaining ACR parameters: Patient assessment of pain; Patient Global Assessment of Disease Activity; Investigator Global Assessment of Disease Activity; participant self-rated assessment of disability measured by the Health Assessment Questionnaire Disability Index (HAQ-DI); and acute phase response (erythrocyte sedimentation rate [ESR] or C-reactive protein [CRP]). | ITT Population | Posted | Number | 95% Confidence Interval | percentage of participants | Week 24 |
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| Primary | Improvement in Fatigue at Week 4 Assessed as Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scores | The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). Clinically relevant improvement is defined as a greater than or equal to (≥)5-point change from Baseline. | ITT population; n=number of participants assessed for the specified parameter at a given visit. | Posted | Mean | Standard Deviation | units on a scale | Week 4 |
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| Secondary | Percent Change From Baseline to Week 24 in TJC | Sixty-eight (68) joints were assessed at each visit for tenderness; joints were assessed and classified as tender/not tender. Tender joint count 68 (TJC-68) was calculated as the number of tender joints from 68 joints; the number of tender joints was summed (maximum score 68). Calculated values were used for the analysis. A negative score indicated improvement. | ITT population | Posted | Mean | Standard Deviation | percent change in tender joints | Week 24 |
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| Secondary | Percent Change From Baseline to Week 24 in SJC | Sixty-six (66) joints were assessed at each visit for swelling; joints were assessed and classified as swollen/not swollen. Swollen joint count 66 (SJC-66) was calculated as the number of swollen joints from 66 joints; the number of swollen joints was summed (maximum score 66). Calculated values were used for the analysis. A negative score indicated improvement. | ITT population | Posted | Mean | Standard Deviation | percent change in swollen joints | Week 24 |
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| Secondary | Percent Change From Baseline to Week 24 in Patient Global Assessment of Pain | The participant's assessment of their current level of pain was displayed on a 100-millimeter (mm) horizontal visual analog scale (VAS). The left-hand extreme of the line was described as "no pain" and the right-hand as "unbearable pain". The participant was asked to mark the line that corresponded to their current level of pain; the distance from the left edge was recorded. | ITT population | Posted | Mean | Standard Deviation | percent change in mm | Week 24 |
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| Secondary | Percent Change From Baseline to Week 24 in Patient's Global Assessment of Disease Activity | The participant's overall assessment of their current disease activity was displayed on a 100-mm horizontal VAS. The left-hand extreme of the line was described as "no disease activity" (symptom free and no arthritis symptoms) and the right-hand extreme as "maximum disease activity" (maximum arthritis disease activity). Participants were asked to assess their current level of disease activity and mark the line; the distance from the left edge was recorded. | ITT population | Posted | Mean | Standard Deviation | percent change in mm | Week 24 |
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| Secondary | Percent Change From Baseline to Week 24 in Investigator's Global Assessment of Disease Activity | The physician's assessment of the participant's current disease activity was displayed on a 100-mm horizontal VAS. The left-hand extreme of the line was described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme was considered "maximum disease activity". The physician's global assessment of disease activity was completed by the Efficacy Assessor who could or could not be a physician. The assessor was asked to mark the line corresponding to their assessment of the participant's present level of disease activity; the distance from the left edge was recorded. | ITT population | Posted | Mean | Standard Deviation | percent change in mm | Week 24 |
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| Secondary | Percent Change From Baseline to Week 24 in HAQ-DI | HAQ-DI includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Overall score was computed as the sum of the domain scores and divided by the number of domains answered. Total possible score range was 0-3 where 0 (equals)=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. | ITT population | Posted | Mean | Standard Deviation | percent change from baseline | Week 24 |
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| Secondary | Percent Change From Baseline to Week 24 in High-Sensitivity CRP (Hs-CRP) | hs-CRP is an acute phase reactant protein that is a clinical marker for Rheumatoid Arthritis (RA). hsCRP is measured in milligrams per liter (mg/L). | ITT population | Posted | Mean | Standard Deviation | percent change in mg/L | Week 24 |
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| Secondary | Percent Change From Baseline to Week 24 in ESR | ESR is a blood test used to monitor therapy in inflammatory diseases such as RA and reflects acute phase reactant levels. ESR is measured in mm per hour (mm/hr); active disease in RA is defined by an ESR greater than 30 mm/hr. | ITT population | Posted | Mean | Standard Deviation | percent change in mm/hr | Week 24 |
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| Secondary | Percentage of Participants With a Response at Week 24 by European League Against Rheumatism (EULAR) Category | Disease response was assessed using EULAR Disease Activity Score Based on 28-Joint Count (DAS28) categories of Good, Moderate, or No Response. Good response was defined as a DAS28 score of less than (<)3.2 and improvement from baseline of >1.2; Moderate response was defined as a DAS28 score of 3.2-5.1 and improvement from baseline of 1.2-0.6 or a DAS28 score of >5.1 and improvement from baseline of >1.2; No response was defined as a DAS28 score of >5.1 and improvement from baseline of <1.2. Participants who discontinued prematurely were identified as non-responders. | ITT population | Posted | Number | 95% Confidence Interval | percentage of participants | Week 24 |
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| Secondary | Percentage of Participants With a Response at Week 24 by DAS28 Category | DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the ESR (mm/hr) and patient's global assessment of disease activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2=low disease activity, DAS28 >5.1=high disease activity and DAS <2.6=remission. | ITT population | Posted | Number | 95% Confidence Interval | percentage of participants | Week 24 |
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| Secondary | Percent Change From Baseline to Week 24 in DAS28 Score | DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the ESR (mm/hr) and patient's global assessment of disease activity (participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2=low disease activity, DAS28 >5.1=high disease activity and DAS <2.6=remission. | ITT population | Posted | Mean | Standard Deviation | percent change from baseline | Week 24 |
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| Secondary | Percentage of Participants With an Improvement of ≥1 g/dL in Hemoglobin | ITT population | Posted | Number | 95% Confidence Interval | percentage of participants | Week 24 |
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| Secondary | Number of Days as Assessed by Short Form-Health and Labour Questionnaire (SF-HLQ) | The SF-HLQ assessed productivity losses related to health problems in individuals with paid or unpaid work and consists of three modules (absenteeism from paid work, production losses without absenteeism from paid work and hindrance in the performance of paid and unpaid work). Any missed working days or number of worked days with reduced efficiency during the last month were reported. | ITT population; n=number of participants assessed for the specified parameter. | Posted | Mean | Standard Deviation | days | Baseline |
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| Secondary | Change From Baseline to Weeks 12 and 24 in Number of Days as Assessed by SF-HLQ | The SF-HLQ assessed productivity losses related to health problems in individuals with paid or unpaid work and consists of three modules (absenteeism from paid work, production losses without absenteeism from paid work and hindrance in the performance of paid and unpaid work). Any missed working days or number of worked days with reduced efficiency during the last month were reported. | ITT population; n=number of participants assessed for the specified parameter. | Posted | Mean | Standard Deviation | days | Weeks 12 and 24 |
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| Secondary | Number of Hours as Assessed by SF-HLQ | Number of working hours lost, and number of hours of support in in taking over and performing usual household tasks in the last month: chores done by family members, chores done by other persons receiving no pay, home care, other paid care, total number of unpaid hours, and total number of hours during the last month were reported. | ITT population; n=number of participants assessed for the specified parameter. | Posted | Mean | Standard Deviation | hours | Baseline |
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| Secondary | Change From Baseline to Weeks 12 and 24 in Number of Hours as Assessed by SF-HLQ | Number of working hours lost, and number of hours of support in in taking over and performing usual household tasks in the last month: chores done by family members, chores done by other persons receiving no pay, home care, other paid care, total number of unpaid hours, and total number of hours during the last month were reported. Changes from baseline were only calculated in participants who completed the questionnaire at all times (baseline, Week 12, and Week 24). Negative number indicates improvement. | ITT population; n=number of participants assessed for the specified parameter. | Posted | Mean | Standard Deviation | hours | Baseline |
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| Secondary | SF-HLQ Hindrance Score | Participants were asked if their health problems hindered their paid work on a scale of 1 to 3 (1=no, 2=yes, slightly, 3=yes, very much) and their unpaid work including household work, going shopping, odd jobs, specific activities sharing the household on a scale of 0 to 3 (0=performed without being bothered by healthy problems; 1=performed although bothered by health problems; 2=not performed because of health problems; 3=not performed for reasons other than health problems). The total hindrance score for unpaid work was derived by adding up the item scores. This hindrance score is a measure of the hindrance experienced as a result of health problems during the performance of unpaid work. The minimum score per item for hindrance score was 0, maximum score was 2 (Score of 3 was not considered since the reasons were "other than health problems"). Total score was calculated by adding all 4 items together and ranged from 0 (best possible score) to 8 (worst possible score). | ITT population; n=number of participants assessed for the specified parameter. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Secondary | Change From Baseline to Weeks 12 and 24 SF-HLQ Hindrance Score | Participants were asked if health problems hindered their paid work on a scale of 1 to 3 (1=no, 2=yes, slightly, 3=yes, very much) and their unpaid work including household work, going shopping, odd jobs, specific activities sharing the household on a scale of 0 to 3 (0=performed without being bothered by healthy problems; 1=performed although bothered by health problems; 2=not performed because of health problems; 3=not performed for reasons other than health problems). Hindrance score is a measure of the hindrance experienced as a result of health problems during the performance of unpaid work. The minimum score per item for hindrance score was 0, maximum score was 2 (Score of 3 was not considered since the reasons were "other than health problems"). Total score was calculated by adding all 4 items together and ranged from 0 (best possible score) to 8 (worst possible score). A negative change from baseline indicates improvement. | ITT population; n=number of participants assessed for the specified parameter. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Secondary | Efficiency as Assessed by SF-HLQ | Participants were ask to rate their efficiency in working on a scale of of 0 to 10 (0=very worse, 10=as usual). Overall efficiency score was based on the first 6 items of Question 6, which is a descriptive instrument comprised of 7 items designed to evaluate the specific problems affecting production. These 7 items relate to the effect of health problems on concentration, work pace, the need to be alone, making decisions, postponing and transferring work to others. The participant can choose from 4 possible answers: (almost) never, sometimes, often and (nearly) always. Efficiency score range=6 to 24; higher scores indicate higher impairment. | ITT population; n=number of participants assessed for the specified parameter. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Secondary | Change From Baseline to Weeks 12 and 24 in Efficiency as Assessed by SF-HLQ | Participants were ask to rate their efficiency in working on a scale of of 0 to 10 (0=very worse, 10=as usual). Overall efficiency score was based on the first 6 items of Question 6, which is a descriptive instrument comprised of 7 items designed to evaluate the specific problems affecting production. These 7 items relate to the effect of health problems on concentration, work pace, the need to be alone, making decisions, postponing and transferring work to others. The participant can choose from 4 possible answers: (almost) never, sometimes, often and (nearly) always. Efficiency score range=6 to 24; higher scores indicate higher impairment. Change from baseline was only calculated for participants who completed the questionnaire at all times (baseline, Week 12 and Week 24). A negative change from baseline indicates improvement. | ITT population; n=number of participants assessed for the specified parameter. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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Adverse events (AEs) were collected through the entire study period.
Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events.
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 | Tocilizumab 8 mg/kg | Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions. | 4 | 105 | 64 | 105 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain | General disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
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| Deep Vein Thrombosis | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Frequent bowel movements | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Discomfort | General disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Anaphylactic reaction | Immune system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Abscess | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Candidiasis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Folliculitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Gastrointestinal infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Herpes simplex | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Laryngitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Mastitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Skin infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Fractured coccyx | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
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| Blood cholesterol increased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
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| Blood triglycerides increased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
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| Heart rate increased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
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| Lipids increased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
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| Transaminases abnormal | Investigations | MedDRA (12.0) | Non-systematic Assessment |
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| Transaminases increased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
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| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Angiolipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
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| Gammopathy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
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| Hepatic haemangioma rupture | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Metrorrhagia | Reproductive system and breast disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Pigmentation disorder | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Bunion operation | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Hypertensive crisis | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Phlebitis | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
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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 |
|---|---|
| C502936 | tocilizumab |
Not provided
Not provided
Not provided
| Title | Measurements |
|---|---|
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| Week 8 (n=100) |
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| Week 12 (n=94) |
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| Week 16 (n=95) |
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| Week 20 (n=90) |
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| Week 24/End of Study (n=100) |
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| Week 2 (n=99) |
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| Week 4 (n=101) |
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| Week 8 (n=100) |
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| Week 12 (n=94) |
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| Week 16 (n=95) |
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| Week 20 (n=90) |
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| Week 24/End of Study (n=100) |
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