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This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo, both in combination with DMARDs, in patients with active rheumatoid arthritis who currently have an inadequate response to DMARD therapy. Patients will be randomized 2:1 to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks, in conjunction with stable DMARD therapy. 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 |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tocilizumab [RoActemra/Actemra] | Drug | 8mg/kg iv every 4 weeks for 24 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With an American College of Rheumatology (ACR)20 Response at Week 24 | To achieve an ACR20 response required at least a 20% improvement, compared with baseline, in both (tender joints count)TJC and (swollen joints count) SJC, as well as in 3 out of 5 additional ACR core set variables: physician's global assessment of disease activity, participant's global assessment of disease activity, participant's assessment of pain, health assessment questionnaire disease index (HAQ-DI) and C-reactive protein (CRP). CRP was used primarily for the calculation of the ACR response; if missing, Erythrocyte Sedimentation Rate (ESR) was substituted. ITT sensitivity analysis was carried out using an alternative imputation method (last observation carried forward [LOCF]). | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With ACR50 and ACR70 Responses at Week 24 | To achieve an ACR50 or ACR 70 response required at least a 50% or 70% improvement, compared with baseline in both TJC and SJC, as well as in 3 out of 5 additional ACR core set variables: physician's global assessment of disease activity, participant's global assessment of disease activity, participant's assessment of pain, HAQ-DI and CRP. CRP was used primarily for the calculation of the ACR response; if missing, ESR was substituted. |
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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 |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | 100044 | China | |||
| Beijing Union Hospital |
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo + DMARDs | Participants received placebo intravenously (iv) every 4 weeks up to 24 weeks in combination with stable DMARD (disease modifying antirheumatic drugs) therapy |
| FG001 | Tocilizumab + DMARDs | Participants received tocilizumab 8 milligrams/kilogram (mg/kg) intravenously (iv) every 4 weeks up to 24 weeks in combination with stable DMARD (disease modifying antirheumatic drugs) therapy |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent-to-Treat (ITT) Population: The ITT population included all randomized participants who received at least one infusion of study treatment; Per Protocol (PP) Population: The PP population included all participants in the ITT population who adhered to the protocol.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo + DMARDs | Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy |
| BG001 | Tocilizumab + DMARDs | Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With an American College of Rheumatology (ACR)20 Response at Week 24 | To achieve an ACR20 response required at least a 20% improvement, compared with baseline, in both (tender joints count)TJC and (swollen joints count) SJC, as well as in 3 out of 5 additional ACR core set variables: physician's global assessment of disease activity, participant's global assessment of disease activity, participant's assessment of pain, health assessment questionnaire disease index (HAQ-DI) and C-reactive protein (CRP). CRP was used primarily for the calculation of the ACR response; if missing, Erythrocyte Sedimentation Rate (ESR) was substituted. ITT sensitivity analysis was carried out using an alternative imputation method (last observation carried forward [LOCF]). | ITT Population | Posted | Number | Percentage of Participants | Week 24 |
|
Adverse events were monitored and recorded throughout the study.
There are 70 participants randomized in Placebo+DMARDs group. Of these, 2 participants were excluded from safety population because one didn't receive any treatment while another received treatment but had no post-baseline safety assessment. Thus, a total of 68 participants were included in safety Population.
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 + DMARDs | Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abscess Limb | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann- LaRoche | 800-821-8590 | genentech@druginfo.com |
Not provided
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C502936 | tocilizumab |
Not provided
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| Placebo |
| Drug |
iv every 4 weeks for 24 weeks |
|
| Week 24 |
| Number of Participants Who Received Escape Therapy | Participants who did not achieve a 20% improvement from baseline in both SJC and TJC at week 16 could, if requested and deemed necessary by the investigator, receive escape therapy, comprising adjustment of the background DMARD dose and/or treatment with a different traditional DMARD. | 24 Weeks |
| Change in Tender and Swollen Joint Counts From Baseline to Week 24 | 68 joints were assessed for tenderness and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68. 66 joints were assessed for swelling and joints were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66. | Baseline and Week 24 |
| Change in Participant's Global Assessment of Disease Activity From Baseline to Week 24 | The participant's global assessment of disease activity is assessed on a 0 to 100 mm horizontal visual analogue scale (VAS) by the participant. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement. | Baseline and Week 24 |
| Change in Physician's Global Assessment of Disease Activity From Baseline to Week 24 | The physician's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as "maximum disease activity" (maximum arthritis disease activity). | Baseline and Week 24 |
| Change in Participant's Global Assessment of Pain From Baseline to Week 24 | The participants assessed their pain on a 0 to 100 mm VAS. The left-hand extreme of the line equals 0 mm, and is described as "no pain" and the right-hand extreme equals 100 mm as "unbearable pain". A negative change indicated improvement. | Baseline and Week 24 |
| Change in C-Reactive Protein From Baseline to Week 24 | The serum concentration of CRP an acute phase inflammatory marker, is measured in milligrams/deciliter (mg/dL). A reduction in the level is considered an improvement. | Baseline and Week 24 |
| Change in ESR From Baseline to Week 24 | The ESR was measured in mm/hour. A reduction in the level is considered an improvement. | Baseline and Week 24 |
| Percentage of Participants With Low Disease Activity and in Clinical Remission | DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, ESR and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 less than or equal to (≤3.2) = low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity. | Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24 |
| Change From Baseline to Week 24 in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score | FACIT-F is a 13-item questionnaire. Patients 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 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). A higher score reflects an improvement in health status. | Baseline and Week 24 |
| Mean Rheumatoid Factor at Baseline and Week 24 | Rheumatoid factor (RF) is a disease characteristic and more than 85% of the participants studied were positive for the factor. These data are from patients who were RF positive. RF level was reported in international units/milliliter (IU/mL). A positive RF= >15 IU/mL. | Baseline and 24 Weeks |
| Change in Hemoglobin From Baseline to Week 24 | Levels of hemoglobin were determined in grams/liter (g/L)as a measure of anemia in participants | Baseline and 24 Weeks |
| Change in Health Assessment Questionnaire - Disease Index (HAQ-DI) From Baseline to Week 24 | HAQ-DI is a self-completed participant questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from baseline indicated improvement. | Baseline and 24 Weeks |
| Percentage of Participants With ACR20 Response by First Week of Onset | ACR 20 responses are summarized by first onset as a percentage of the total number of responders at week 24. The number of participants first achieving an ACR20 response at each time point is represented by treatment arm as a proportion of the total number of participants that had an ACR20 response at Week 24 using n as the denominator. | Weeks 2, 4, 8, 12, 16, 20, and 24 |
| Time to First Low Disease Activity | Time to Low disease activity was calculated as the number of days from the first dose of drug administration to the date of first achievement of DAS28≤3.2. | Weeks 2, 4, 8, 12, 16, 20, and 24 |
| Time to First Remission | Time to first Remission was calculated as the number of days from the date of first dose of study drug administration to the date of first achievement of DAS<2.6 | Weeks 2, 4, 8, 12, 16, 20, and 24 |
| Beijing |
| 100730 |
| China |
| General Hospital of Chinese PLA; Department of Hematology | Beijing | 100853 | China |
| The Third Affiliated Hospital of Sun Yat-Sen University | Guangzhou | 510630 | China |
| The 1st Affiliated Hospital of Harbin Medical University | Harbin | 150001 | China |
| Qilu Hospital of Shandong University | Jinan | 250012 | China |
| Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | 200127 | China |
| Changhai Hospital of Shanghai | Shanghai | 200433 | China |
| The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital) | Xi'an | 710032 | China |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants received placebo intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy
| OG001 | Tocilizumab + DMARDs | Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy |
|
|
|
| Secondary | Percentage of Participants With ACR50 and ACR70 Responses at Week 24 | To achieve an ACR50 or ACR 70 response required at least a 50% or 70% improvement, compared with baseline in both TJC and SJC, as well as in 3 out of 5 additional ACR core set variables: physician's global assessment of disease activity, participant's global assessment of disease activity, participant's assessment of pain, HAQ-DI and CRP. CRP was used primarily for the calculation of the ACR response; if missing, ESR was substituted. | ITT Population | Posted | Number | Percentage of Participants | Week 24 |
|
|
|
|
| Secondary | Number of Participants Who Received Escape Therapy | Participants who did not achieve a 20% improvement from baseline in both SJC and TJC at week 16 could, if requested and deemed necessary by the investigator, receive escape therapy, comprising adjustment of the background DMARD dose and/or treatment with a different traditional DMARD. | ITT Population | Posted | Number | Number of participants | 24 Weeks |
|
|
|
| Secondary | Change in Tender and Swollen Joint Counts From Baseline to Week 24 | 68 joints were assessed for tenderness and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68. 66 joints were assessed for swelling and joints were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66. | ITT Population | Posted | Mean | Standard Deviation | Joints | Baseline and Week 24 |
|
|
|
|
| Secondary | Change in Participant's Global Assessment of Disease Activity From Baseline to Week 24 | The participant's global assessment of disease activity is assessed on a 0 to 100 mm horizontal visual analogue scale (VAS) by the participant. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement. | ITT Population | Posted | Mean | Standard Deviation | mm | Baseline and Week 24 |
|
|
|
|
| Secondary | Change in Physician's Global Assessment of Disease Activity From Baseline to Week 24 | The physician's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as "maximum disease activity" (maximum arthritis disease activity). | ITT Population | Posted | Mean | Standard Deviation | mm | Baseline and Week 24 |
|
|
|
|
| Secondary | Change in Participant's Global Assessment of Pain From Baseline to Week 24 | The participants assessed their pain on a 0 to 100 mm VAS. The left-hand extreme of the line equals 0 mm, and is described as "no pain" and the right-hand extreme equals 100 mm as "unbearable pain". A negative change indicated improvement. | ITT Population | Posted | Mean | Standard Deviation | mm | Baseline and Week 24 |
|
|
|
|
| Secondary | Change in C-Reactive Protein From Baseline to Week 24 | The serum concentration of CRP an acute phase inflammatory marker, is measured in milligrams/deciliter (mg/dL). A reduction in the level is considered an improvement. | ITT Population | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 24 |
|
|
|
|
| Secondary | Change in ESR From Baseline to Week 24 | The ESR was measured in mm/hour. A reduction in the level is considered an improvement. | ITT Population | Posted | Mean | Standard Deviation | mm/hour | Baseline and Week 24 |
|
|
|
|
| Secondary | Percentage of Participants With Low Disease Activity and in Clinical Remission | DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, ESR and global health assessment (participant rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 less than or equal to (≤3.2) = low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity. | ITT Population; n=number of participants analyzed. | Posted | Number | Percentage of Participants | Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24 |
|
|
|
| Secondary | Change From Baseline to Week 24 in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score | FACIT-F is a 13-item questionnaire. Patients 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 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). A higher score reflects an improvement in health status. | ITT Population | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 24 |
|
|
|
|
| Secondary | Mean Rheumatoid Factor at Baseline and Week 24 | Rheumatoid factor (RF) is a disease characteristic and more than 85% of the participants studied were positive for the factor. These data are from patients who were RF positive. RF level was reported in international units/milliliter (IU/mL). A positive RF= >15 IU/mL. | ITT Population | Posted | Mean | Standard Deviation | IU/mL | Baseline and 24 Weeks |
|
|
|
|
| Secondary | Change in Hemoglobin From Baseline to Week 24 | Levels of hemoglobin were determined in grams/liter (g/L)as a measure of anemia in participants | ITT Population | Posted | Mean | Standard Deviation | g/L | Baseline and 24 Weeks |
|
|
|
|
| Secondary | Change in Health Assessment Questionnaire - Disease Index (HAQ-DI) From Baseline to Week 24 | HAQ-DI is a self-completed participant questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. The HAQ-DI is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from baseline indicated improvement. | ITT Population | Posted | Mean | Standard Deviation | units on a scale | Baseline and 24 Weeks |
|
|
|
|
| Secondary | Percentage of Participants With ACR20 Response by First Week of Onset | ACR 20 responses are summarized by first onset as a percentage of the total number of responders at week 24. The number of participants first achieving an ACR20 response at each time point is represented by treatment arm as a proportion of the total number of participants that had an ACR20 response at Week 24 using n as the denominator. | ITT Population | Posted | Number | Percentage of Participants | Weeks 2, 4, 8, 12, 16, 20, and 24 |
|
|
|
| Secondary | Time to First Low Disease Activity | Time to Low disease activity was calculated as the number of days from the first dose of drug administration to the date of first achievement of DAS28≤3.2. | ITT Population | Posted | Median | 95% Confidence Interval | Days | Weeks 2, 4, 8, 12, 16, 20, and 24 |
|
|
|
| Secondary | Time to First Remission | Time to first Remission was calculated as the number of days from the date of first dose of study drug administration to the date of first achievement of DAS<2.6 | ITT Population | Posted | Median | 95% Confidence Interval | Days | Weeks 2, 4, 8, 12, 16, 20, and 24 |
|
|
|
| 4 |
| 68 |
| 19 |
| 68 |
| EG001 | Tocilizumab + DMARDs | Participants received tocilizumab 8 mg/kg intravenously every 4 weeks up to 24 weeks in combination with stable DMARD therapy | 1 | 139 | 59 | 139 |
| Herpes Zoster | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
|
| Uterine Infection | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Neutrophil Count Decreased | Investigations | MedDRA 12.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
|
| Abscess limb | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
|
| Helicobacter infection | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
|
| Uterine infection | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 12.1 | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 12.1 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 12.1 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 12.1 | Non-systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA 12.1 | Non-systematic Assessment |
|
| Blood bilirubin unconjugated increased | Investigations | MedDRA 12.1 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 12.1 | Non-systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 12.1 | Non-systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Gingival ulceration | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Infusion related reaction | General disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Dysfunctional uterine bleeding | Reproductive system and breast disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Menstruation irregular | Reproductive system and breast disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Uterine cervical erosion | Reproductive system and breast disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 12.1 | 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.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| 0.0345 |
Comparison of ACR 70 responders in placebo and Tocilizumab groups |
| Superiority or Other |
Placebo + DMARDs Vs Tocilizumab + DMARDs analysis for Tender Joint Count |
| ANCOVA |
| <0.0001 |
p value was calculated using the difference between core set values of the two arms. |
| Mean Difference (Final Values) |
| -8.7 |
| 2-Sided |
| 95 |
| -11.3 |
| -6.1 |
| Superiority or Other |
| Baseline Remission first achieved (n=69, 139) |
|
| Week 2 Low Disease Activity (n= 67,138) |
|
| Week 2 Remission (n= 67,138) |
|
| Week 2 Remission first achieved (n= 67,138) |
|
| Week 4 Low Disease Activity (n= 67,139) |
|
| Week 4 Remission (n=67,139) |
|
| Week 4 Remission first achieved (n=67,139) |
|
| Week 8 Low Disease Activity (n= 67,139) |
|
| Week 8 Remission (n=67,139) |
|
| Week 8 Remission first achieved (n=67,139) |
|
| Week 12 Low Disease Activity (n=65,138) |
|
| Week 12 Remission (n=65,138) |
|
| Week 12 Remission first achieved (n=65,138) |
|
| Week 16 Low Disease Activity (n=65,136) |
|
| Week 16 Remission (n=65,136) |
|
| Week 16 Remission first achieved (n=65,136) |
|
| Week 20 Low Disease Activity (n=63,134) |
|
| Week 20 Remission (n=63,134) |
|
| Week 20 Remission first achieved (n=63,134) |
|
| Week 24 Low Disease Activity (n=64,131) |
|
| Week 24 Remission (n=64,131) |
|
| Week 24 Remission first achieved (n=64,131) |
|
| First onset at Week 8 |
|
| First onset at Week 12 |
|
| First onset at Week 16 |
|
| First onset at Week 20 |
|
| First onset at Week 24 |
|