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An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocilizumab Core Studies

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ClinicalTrials.gov Identifier: NCT00720798
Recruitment Status : Completed
First Posted : July 23, 2008
Results First Posted : September 30, 2014
Last Update Posted : September 30, 2014
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: Tocilizumab
Drug: Disease-modifying anti-rheumatic drugs
Drug: Non-steroidal anti-inflammatory drugs
Drug: Oral corticosteroids
Enrollment 2067
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tocilizumab
Hide Arm/Group Description Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Period Title: Overall Study
Started 2067
Completed 1311
Not Completed 756
Reason Not Completed
Adverse Event             304
Death             39
Insufficient Therapeutic Response             129
Protocol Violation             4
Refused Treatment             151
Failure to Return             46
Reason not Specified             83
Arm/Group Title Tocilizumab
Hide Arm/Group Description Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Overall Number of Baseline Participants 2067
Hide Baseline Analysis Population Description
All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2067 participants
52.2  (12.60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2067 participants
Female
1689
  81.7%
Male
378
  18.3%
1.Primary Outcome
Title Percentage of Participants With ≥ 1 Adverse Event
Hide Description [Not Specified]
Time Frame Baseline to the end of the study (up to 7 years, 7 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Arm/Group Title Tocilizumab
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Overall Number of Participants Analyzed 2067
Measure Type: Number
Unit of Measure: Percentage of participants
96.3
2.Secondary Outcome
Title Percentage of Participants Who Withdrew From Treatment
Hide Description [Not Specified]
Time Frame Baseline to the end of the study (up to 7 years, 7 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Arm/Group Title Tocilizumab
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Overall Number of Participants Analyzed 2067
Measure Type: Number
Unit of Measure: Percentage of participants
36.6
3.Secondary Outcome
Title Percentage of Participants With Concomitant Oral Corticosteroid Therapy
Hide Description

Concomitant therapy with oral corticosteroids (up 5 to 10 mg daily prednisone or equivalent) was permitted in the study. Reduction of oral corticosteroids was permitted, but not required, if a patient achieved at least a 50% improvement from baseline in both tender joint count and swollen joint count.

The data are reported for each 6-month period of the study where a month = 28 days. The last 6-month period is for months 96 through 101. The actually study duration in 28-day months was 98.85 months.

Time Frame Baseline to the end of the study (up to 7 years, 7 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
Arm/Group Title Tocilizumab
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Overall Number of Participants Analyzed 2067
Measure Type: Number
Unit of Measure: Percentage of participants
0 - 6 Months, n = 2067 55.8
6 - 12 Months, n = 2041 55.3
12 - 18 Months, n = 1944 54.6
18 - 24 Months, n = 1832 54.3
24 - 30 Months, n = 1753 53.2
30 - 36 Months, n = 1677 52.9
36 - 42 Months, n = 1620 51.3
42 - 48 Months, n = 1568 50.4
48 - 54 Months, n = 1516 50.6
54 - 60 Months, n = 1475 50.1
60 - 66 Months, n = 1423 49.2
66 - 72 Months, n = 1342 48.4
72 - 78 Months, n = 788 48.7
78 - 84 Months, n = 62 72.6
84 - 90 Months, n = 34 79.4
90 - 96 Months, n = 10 70.0
96 - 102 Months, n = 2 0.0
4.Secondary Outcome
Title Percentage of Participants Who Changed From Monotherapy to Combination Therapy
Hide Description Participants who entered this study from study WA17824 on tocilizumab monotherapy, who did not achieve a 50% reduction in tender and swollen joint counts from Baseline of study WA17824, could add methotrexate or another allowable disease-modifying anti-rheumatic drug, according to the investigator’s practice and as tolerated by the patient, at any time during this study.
Time Frame Baseline to Week 296
Hide Outcome Measure Data
Hide Analysis Population Description
All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants from the core study WA17824 are included in the analysis.
Arm/Group Title Tocilizumab
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Overall Number of Participants Analyzed 243
Measure Type: Number
Unit of Measure: Percentage of participants
Week 8 1.2
Week 12 0.4
Week 24 15.6
Week 28 7.0
Week 32 2.5
Week 36 1.6
Week 40 0.4
Week 44 0.4
Week 48 1.6
Week 52 0.8
Week 54 0.8
Week 64 1.2
Week 68 0.8
Week 72 0.8
Week 76 0.4
Week 88 0.8
Week 96 1.2
Week 100 0.8
Week 104 0.4
Week 108 0.4
Week 112 0.4
Week 116 0.4
Week 120 0.4
Week 140 0.4
Week 152 0.8
Week 184 0.4
Week 196 0.4
Week 200 0.8
Week 292 0.4
Week 296 0.8
5.Secondary Outcome
Title Percentage of Participants With an Improvement of at Least 20%, 50%, 70%, or 90% in the American College of Rheumatology (ACR) Score (ACR20/50/70/90) From Baseline at Weeks 24, 48, 108, 156, 204, and 264
Hide Description Improvement must be seen in tender (68 assessed joints) and swollen joint counts (66 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the left end of the scale “no disease activity” [symptom-free and no arthritis symptoms], right end of the scale “maximum disease activity”); patient assessment of pain in the previous 24 hours on a VAS (left end of the scale “no pain”, right end of the scale “unbearable pain”); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate.
Time Frame Baseline to Week 264
Hide Outcome Measure Data
Hide Analysis Population Description
All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.
Arm/Group Title Tocilizumab
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Overall Number of Participants Analyzed 2067
Measure Type: Number
Unit of Measure: Percentage of participants
ACR20 Week 24 (n=1966) 59.5
ACR20 Week 48 (n=1825) 66.7
ACR20 Week 108 (n=1607) 74.1
ACR20 Week 156 (n=1512) 74.3
ACR20 Week 204 (n=1415) 77.5
ACR20 Week 264 (n = 1319) 78.7
ACR50 Week 24 (n=1966) 34.9
ACR50 Week 48 (n=1825) 44.4
ACR50 Week 108 (n=1607) 52.8
ACR50 Week 156 (n=1512) 54.7
ACR50 Week 204 (n=1415) 56.5
ACR50 Week 264 (n= 1319) 58.8
ACR70 Week 24 (n=1966) 17.8
ACR70 Week 48 (n=1825) 25.5
ACR70 Week 108 (n=1607) 33.2
ACR70 Week 156 (n=1512) 35.7
ACR70 Week 204 (n =1415) 38.6
ACR70 Week 264 (n=1319) 40.5
ACR90 Week 24 (n=1966) 4.3
ACR90 Week 48 (n=1825 7.9
ACR90 Week 108 (n=1607) 12.1
ACR90 Week 156 (n=1512) 14.7
ACR90 Week 204 (n=1415) 17.7
ACR90 Week 264 (n=1319) 18.1
6.Secondary Outcome
Title Percentage of Participants Who Achieved a Major Clinical Response at Weeks 48, 96, 144, 192, and 264
Hide Description A major clinical response was defined as maintenance of an improvement of at least 70% in the American College of Rheumatology (ACR) score (ACR70) for at least 24 weeks. Improvement must be seen in tender (68 assessed joints) and swollen joint counts (66 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the left end of the scale “no disease activity” [symptom-free and no arthritis symptoms], right end of the scale “maximum disease activity”); patient assessment of pain in the previous 24 hours on a VAS (left end of the scale “no pain”, right end of the scale “unbearable pain”); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate.
Time Frame Baseline to Week 264
Hide Outcome Measure Data
Hide Analysis Population Description
All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.
Arm/Group Title Tocilizumab
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Overall Number of Participants Analyzed 2067
Measure Type: Number
Unit of Measure: Percentage of participants
Week 48 (n = 1937) 8.5
Week 96 (n = 1745) 16.2
Week 144 (n = 1615) 20.9
Week 192 (n = 1514) 22.9
Week 264 (n = 1358) 24.9
7.Secondary Outcome
Title Percentage of Participants Who Maintained an Improvement of at Least 20%, 50%, or 70% in the American College of Rheumatology (ACR) Score (ACR20/50/70) Consecutively for 24, 48, 96, and 264 Weeks at Weeks 48, 96, 144, 192, and 264
Hide Description Improvement must be seen in tender (68 assessed joints) and swollen joint counts (66 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the left end of the scale “no disease activity” [symptom-free and no arthritis symptoms], right end of the scale “maximum disease activity”); patient assessment of pain in the previous 24 hours on a VAS (left end of the scale “no pain”, right end of the scale “unbearable pain”); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and erythrocyte sedimentation rate.
Time Frame Baseline to Week 264
Hide Outcome Measure Data
Hide Analysis Population Description
All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.
Arm/Group Title Tocilizumab
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Overall Number of Participants Analyzed 2067
Measure Type: Number
Unit of Measure: Percentage of participants
ACR20 Week 48: Maintained 24 weeks (n=1937) 41.2
ACR20 Week 96: Maintained 24 weeks (n=1745) 53.0
ACR20 Week 96: Maintained 48 weeks (n=1745) 43.0
ACR20 Week 144: Maintained 24 weeks (n=1615) 56.3
ACR20 Week 144: Maintained 48 weeks (n=1615) 48.7
ACR20 Week 144: Maintained 96 weeks (n=1615) 35.6
ACR20 Week 192: Maintained 24 weeks (n=1514) 60.0
ACR20 Week 192: Maintained 48 weeks (n=1514) 52.3
ACR20 Week 192: Maintained 96 weeks (n=1514) 41.3
ACR20 Week 192: Maintained 144 weeks (n=1514) 31.8
ACR20 Week 264: Maintained 24 weeks (n=1358) 63.0
ACR20 Week 264: Maintained 48 weeks (n=1358) 54.7
ACR20 Week 264: Maintained 96 weeks (n=1358) 46.2
ACR20 Week 264: Maintained 144 weeks (n=1358) 38.7
ACR20 Week 264: Maintained 192 weeks (n=1358) 32.6
ACR50 Week 48: Maintained 24 weeks (n=1937) 20.7
ACR50 Week 96: Maintained 24 weeks (n=1745) 32.0
ACR50 Week 96: Maintained 48 weeks (n=1745) 22.8
ACR50 Week 144: Maintained 24 weeks (n=1615) 36.9
ACR50 Week 144: Maintained 48 weeks (n=1615) 28.4
ACR50 Week 144: Maintained 96 weeks (n=1615) 18.1
ACR50 Week 192: Maintained 24 weeks (n=1514) 39.8
ACR50 Week 192: Maintained 48 weeks (n=1514) 33.0
ACR50 Week 192: Maintained 96 weeks (n=1514) 22.7
ACR50 Week 192: Maintained 144 weeks (n=1514) 15.9
ACR50 Week 264: Maintained 24 weeks (n=1358) 42.3
ACR50 Week 264: Maintained 48 weeks (n=1358) 34.7
ACR50 Week 264: Maintained 96 weeks (n=1358) 27.6
ACR50 Week 264: Maintained 144 weeks (n=1358) 21.7
ACR50 Week 264: Maintained 192 weeks (n=1358) 16.6
ACR70 Week 48: Maintained 24 weeks (n=1937) 8.5
ACR70 Week 96: Maintained 24 weeks (n=1745) 16.2
ACR70 Week 96: Maintained 48 weeks (n=1745) 11.2
ACR70 Week 144: Maintained 4 weeks (n=1615) 20.9
ACR70 Week 144: Maintained 48 weeks (n=1615) 15.0
ACR70 Week 144: Maintained 96 weeks (n=1615) 8.7
ACR70 Week 192: Maintained 24 weeks (n=1514) 22.9
ACR70 Week 192: Maintained 48 weeks (n=1514) 17.6
ACR70 Week 192: Maintained 96 weeks (n=1514) 11.4
ACR70 Week 192: Maintained 144 weeks (n=1514) 7.3
ACR70 Week 264: Maintained 24 weeks (n=1358) 24.9
ACR70 Week 264: Maintained 48 weeks (n=1358) 19.7
ACR70 Week 264: Maintained 96 weeks (n=1358) 14.4
ACR70 Week 264: Maintained 144 weeks (n=1358) 11.0
ACR70 Week 264: Maintained 192 weeks (n=1358) 7.7
8.Secondary Outcome
Title Swollen and Tender Joint Count (SJC/TJC) at Baseline and Weeks 24, 48, 108, 156, 204, and 264
Hide Description The number of swollen (66 assessed joints) and tender (68 assessed joints) joints was assessed. Joints were physically examined and classified as swollen/not swollen and tender/not tender by pressure and joint manipulation.
Time Frame Baseline to Week 264
Hide Outcome Measure Data
Hide Analysis Population Description
All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.
Arm/Group Title Tocilizumab
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Overall Number of Participants Analyzed 2067
Mean (Standard Deviation)
Unit of Measure: Joints
Baseline SJC (n = 2047) 17.4  (11.96)
Week 24 SJC (n = 2010) 8.2  (9.43)
Week 48 SJC (n = 1924) 6.4  (8.75)
Week 108 SJC (n = 1692) 4.2  (6.69)
Week 156 SJC (n = 1580) 4.0  (7.09)
Week 204 SJC (n = 1482) 3.2  (5.96)
Week 264 SJC (n = 1352) 2.9  (5.85)
Baseline TJC (n = 2047) 27.3  (16.97)
Week 24 TJC (n = 2010) 12.8  (14.10)
Week 48 TJC (n = 1924) 10.3  (12.99)
Week 108 TJC (n = 1692) 7.8  (11.04)
Week 156 TJC (n = 1580) 7.2  (11.03)
Week 204 TJC (n = 1482) 6.1  (9.83)
Week 264 TJC (n = 1352) 5.6  (9.48)
9.Secondary Outcome
Title Disease Activity and Pain at Baseline and Weeks 24, 48, 108, 156, 204, and 264
Hide Description Participant’s made a global assessment of their current disease activity on a 100 mm horizontal visual analogue scale (VAS). The left end of the scale indicated “no disease activity” (symptom-free and no arthritis symptoms, score = 0) and the right end indicated “maximum disease activity” (maximum arthritis disease activity, score = 100). The participant’s treating physician made a global assessment of the participant’s current disease activity on a 100 mm horizontal VAS. The left end of the scale indicated “no disease activity” (symptom-free and no arthritis symptoms, score = 0) and the right end indicated “maximum disease activity” (maximum arthritis disease activity, score = 100). Participant’s made an assessment of their current level of pain on a 100 mm horizontal VAS. The left end of the scale indicated “no pain” (score = 0) and the right end of the scale indicated “unbearable pain” (score = 100).
Time Frame Baseline to Week 264
Hide Outcome Measure Data
Hide Analysis Population Description
All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.
Arm/Group Title Tocilizumab
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Overall Number of Participants Analyzed 2067
Mean (Standard Deviation)
Unit of Measure: mm
Participant Disease Activity - Baseline (n=2039) 60.5  (25.52)
Participant Disease Activity - Week 24 (n=1989) 34.4  (26.03)
Participant Disease Activity - Week 48 (n=1840) 31.7  (25.25)
Participant Disease Activity - Week 108 (n=1621) 29.2  (24.75)
Participant Disease Activity - Week 156 (n=1515) 28.5  (25.16)
Participant Disease Activity - Week 204 (n=1427) 27.4  (24.72)
Participant Disease Activity - Week 264 (n=1328) 27.4  (25.50)
Physician Disease Activity - Baseline (n=2043) 57.3  (22.04)
Physician Disease Activity - Week 24 (n=1990) 26.8  (20.22)
Physician Disease Activity - Week 48 (n=1830) 22.3  (18.93)
Physician Disease Activity - Week 108 (n=1619) 18.6  (17.59)
Physician Disease Activity - Week 156 (n=1516) 17.4  (17.21)
Physician Disease Activity - Week 204 (n=1413) 15.6  (16.49)
Physician Disease Activity - Week 264 (n=1330) 15.1  (16.51)
Participant Pain - Baseline (n=2041) 54.9  (25.00)
Participant Pain - Week 24 (n=1991) 31.0  (24.56)
Participant Pain - Week 48 (n=1842) 28.0  (23.76)
Participant Pain - Week 108 (n=1622) 26.6  (23.52)
Participant Pain - Week 156 (n=1517) 26.2  (23.90)
Participant Pain - Week 204 (n=1428) 25.3  (23.05)
Participant Pain - Week 264 (n=1329) 25.1  (23.72)
10.Secondary Outcome
Title Health Assessment Questionnaire-Disability Index Score at Baseline and Weeks 24, 48, 108, 156, 204, and 264
Hide Description The Health Assessment Questionnaire-Disability Index (HAQ-DI), as a measure of functional ability, consists of 30 questions in 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. There are 4 possible responses to each question (0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do). A domain score is the highest score in that domain. To calculate the overall score, the patient must have a domain score in at least 6 of the 8 domains. The HAQ-DI score is the sum of the domain scores divided by the number of domains that have a non-missing score and ranges from 0 (best) to 3 (worst). A higher score indicates less ability.
Time Frame Baseline to Week 264
Hide Outcome Measure Data
Hide Analysis Population Description
All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.
Arm/Group Title Tocilizumab
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Overall Number of Participants Analyzed 2067
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline (n = 2037) 1.46  (0.660)
Week 24 (n = 2008) 1.04  (0.692)
Week 48 (n = 1853) 0.97  (0.693)
Week 108 (n = 1635) 0.89  (0.694)
Week 156 (n = 1529) 0.87  (0.689)
Week 204 (n = 1438) 0.84  (0.684)
Week 264 (n = 1334) 0.86  (0.696)
11.Secondary Outcome
Title Erythrocyte Sedimentation Rate at Baseline and Weeks 24, 48, 108, 156, 204, and 264
Hide Description Erythrocyte sedimentation rate (ESR) was determined locally.
Time Frame Baseline to Week 264
Hide Outcome Measure Data
Hide Analysis Population Description
All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.
Arm/Group Title Tocilizumab
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Overall Number of Participants Analyzed 2067
Mean (Standard Deviation)
Unit of Measure: mm/h
Baseline (n = 2047) 46.2  (27.45)
Week 24 (n = 1992) 11.3  (14.97)
Week 48 (n = 1830) 10.2  (13.94)
Week 108 (n = 1606) 9.0  (12.79)
Week 156 (n = 1509) 8.9  (12.44)
Week 204 (n = 1412) 8.9  (12.01)
Week 264 (n = 1329) 9.7  (13.51)
12.Secondary Outcome
Title Change in the Disease Activity Score 28 (DAS-28) From Baseline to Weeks 24, 48, 96, and 264
Hide Description The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient’s global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement.
Time Frame Baseline to Week 264
Hide Outcome Measure Data
Hide Analysis Population Description
All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.
Arm/Group Title Tocilizumab
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Overall Number of Participants Analyzed 2067
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 24 (n = 1920) -2.82  (1.559)
Week 48 (n = 1753) -3.20  (1.644)
Week 96 (n = 1596) -3.46  (1.715)
Week 264 (n = 1278) -3.73  (1.742)
13.Secondary Outcome
Title Percentage of Participants Who Were Disease Activity Score 28 (DAS-28) Responders at Weeks 24, 48, 108, 156, 204, and 264
Hide Description A DAS-28 responder was defined as someone who met the European League Against Rheumatism [EULAR] criteria of a good or moderate response. A change of the DAS-28 score from Baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.
Time Frame Baseline to Week 264
Hide Outcome Measure Data
Hide Analysis Population Description
All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.
Arm/Group Title Tocilizumab
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Overall Number of Participants Analyzed 2067
Measure Type: Number
Unit of Measure: Percentage of participants
Week 24 Good (n = 1920) 43.3
Week 48 Good (n = 1753) 51.9
Week 108 Good (n = 1525) 61.1
Week 156 Good (n = 1441) 64.7
Week 204 Good (n = 1358) 67.8
Week 264 Good (n = 1278) 68.8
Week 24 Moderate (n = 1920) 45.1
Week 48 Moderate (n = 1753) 40.0
Week 108 Moderate (n = 1525) 33.2
Week 156 Moderate (n = 1441) 28.7
Week 204 Moderate (n = 1358) 26.4
Week 264 Moderate (n = 1278) 26.1
14.Secondary Outcome
Title Percentage of Participants Who Maintained a Disease Activity Score 28 (DAS-28) Response for 24, 48, 96, 144, and 192 Weeks at Weeks 48, 96, 144, 192, and 264
Hide Description A DAS-28 responder was defined as someone who met the European League Against Rheumatism [EULAR] criteria of a good or moderate response. A change of the DAS-28 score from Baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.
Time Frame Baseline to Week 264
Hide Outcome Measure Data
Hide Analysis Population Description
All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.
Arm/Group Title Tocilizumab
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Overall Number of Participants Analyzed 2067
Measure Type: Number
Unit of Measure: Percentage of participants
Week 48: Maintained response 24 weeks (n=1937) 67.6
Week 96: Maintained response 24 weeks (n=1745) 72.7
Week 96: Maintained response 48 weeks (n=1745) 63.4
Week 144: Maintained response 24 weeks (n=1615) 73.1
Week 144: Maintained response 48 weeks (n=1615) 64.1
Week 144: Maintained response 96 weeks (n=1615) 52.9
Week 192: Maintained response 24 weeks (n=1514) 73.3
Week 192: Maintained response 48 weeks (n=1514) 64.7
Week 192: Maintained response 96 weeks (n=1514) 53.6
Week 192: Maintained response 144 weeks (n=1514) 45.5
Week 264: Maintained response 24 weeks (n = 1358) 76.7
Week 264: Maintained response 48 weeks (n = 1358) 68.6
Week 264: Maintained response 96 weeks (n = 1358) 56.4
Week 264: Maintained response 144 weeks (n = 1358) 48.7
Week 264: Maintained response 192 weeks (n = 1358) 42.1
15.Secondary Outcome
Title Percentage of Participants With a Clinically Relevant Improvement in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Weeks 24, 36, 48, 108, 156, 204, and 264
Hide Description The FACIT-F is a 13-item participant self-report questionnaire that assesses fatigue over the previous 7 days by scoring each item on a 5-point scale (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). An overall FACIT-F score was obtained by summing the scores of all 13 items. The overall score ranged from 0 to 52. A lower score indicates less fatigue. A clinically relevant improvement in the FACIT-F score was defined as a ≥ 5-point increase from Baseline.
Time Frame Baseline to Week 264
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All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.
Arm/Group Title Tocilizumab
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Overall Number of Participants Analyzed 2067
Measure Type: Number
Unit of Measure: Percentage of participants
Week 24 (n = 1984) 59.5
Week 36 (n = 1839) 52.5
Week 48 (n = 1803) 56.0
Week 108 (n = 1616) 56.8
Week 156 (n = 1513) 56.3
Week 204 (n = 1422) 56.4
Week 264 (n = 1320) 61.9
16.Secondary Outcome
Title Percentage of Participants With a Clinically Relevant Improvement in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey at Weeks 24, 48, 108, 156, 204, and 264
Hide Description The SF-36 Health Survey uses participant-reported symptoms on 8 subscales to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role-Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role-Emotional, and Mental Health. Each score was scaled from 0 to 100 with a higher score indicating better HRQoL. A clinically relevant improvement in the Physical and Mental Component Scores of the SF-36 was defined as a ≥ 5-point increase from Baseline.
Time Frame Baseline to Week 264
Hide Outcome Measure Data
Hide Analysis Population Description
All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.
Arm/Group Title Tocilizumab
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
Overall Number of Participants Analyzed 2067
Measure Type: Number
Unit of Measure: Percentage of participants
Week 24 Mental Score (n = 1850) 42.4
Week 48 Mental Score (n = 1789) 44.4
Week 108 Mental Score (n = 1551) 45.3
Week 156 Mental Score (n = 1468) 46.1
Week 204 Mental Score (n = 1377) 47.1
Week 264 Mental Score (n = 1302) 44.9
Week 24 Physical Score (n = 1850) 56.2
Week 48 Physical Score (n = 1789) 61.4
Week 108 Physical Score (n = 1551) 63.2
Week 156 Physical Score (n = 1468) 62.5
Week 204 Physical Score (n = 1377) 64.1
Week 264 Physical Score (n = 1302) 63.7
Time Frame [Not Specified]
Adverse Event Reporting Description All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study.
 
Arm/Group Title Tocilizumab
Hide Arm/Group Description Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
All-Cause Mortality
Tocilizumab
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tocilizumab
Affected / at Risk (%)
Total   727/2067 (35.17%) 
Blood and lymphatic system disorders   
Anaemia  1  8/2067 (0.39%) 
Leukopenia  1  4/2067 (0.19%) 
Thrombocytopenia  1  3/2067 (0.15%) 
Neutropenia  1  2/2067 (0.10%) 
Pancytopenia  1  2/2067 (0.10%) 
Anaemia megaloblastic  1  1/2067 (0.05%) 
Disseminated intravascular coagulation  1  1/2067 (0.05%) 
Cardiac disorders   
Myocardial infarction  1  16/2067 (0.77%) 
Atrial fibrillation  1  13/2067 (0.63%) 
Angina pectoris  1  9/2067 (0.44%) 
Acute myocardial infarction  1  8/2067 (0.39%) 
Cardiac failure congestive  1  6/2067 (0.29%) 
Myocardial ischaemia  1  6/2067 (0.29%) 
Cardiac failure  1  5/2067 (0.24%) 
Coronary artery disease  1  4/2067 (0.19%) 
Arrhythmia  1  2/2067 (0.10%) 
Atrioventricular block complete  1  2/2067 (0.10%) 
Coronary artery occlusion  1  2/2067 (0.10%) 
Coronary artery stenosis  1  2/2067 (0.10%) 
Tachycardia  1  2/2067 (0.10%) 
Angina unstable  1  1/2067 (0.05%) 
Arteriosclerosis coronary artery  1  1/2067 (0.05%) 
Atrial tachycardia  1  1/2067 (0.05%) 
Atrioventricular block second degree  1  1/2067 (0.05%) 
Bradycardia  1  1/2067 (0.05%) 
Cardiac arrest  1  1/2067 (0.05%) 
Cardiac failure chronic  1  1/2067 (0.05%) 
Congestive cardiomyopathy  1  1/2067 (0.05%) 
Diastolic dysfunction  1  1/2067 (0.05%) 
Mitral valve incompetence  1  1/2067 (0.05%) 
Palpitations  1  1/2067 (0.05%) 
Pericardial effusion  1  1/2067 (0.05%) 
Sinus bradycardia  1  1/2067 (0.05%) 
Stress cardiomyopathy  1  1/2067 (0.05%) 
Supraventricular tachycardia  1  1/2067 (0.05%) 
Ventricular extrasystoles  1  1/2067 (0.05%) 
Ventricular tachycardia  1  1/2067 (0.05%) 
Congenital, familial and genetic disorders   
Arnold-chiari malformation  1  1/2067 (0.05%) 
Choledochal cyst  1  1/2067 (0.05%) 
Ear and labyrinth disorders   
Hypoacusis  1  1/2067 (0.05%) 
Sudden hearing loss  1  1/2067 (0.05%) 
Vertigo  1  1/2067 (0.05%) 
Endocrine disorders   
Goitre  1  2/2067 (0.10%) 
Thyroid cyst  1  1/2067 (0.05%) 
Eye disorders   
Cataract  1  3/2067 (0.15%) 
Angle closure glaucoma  1  1/2067 (0.05%) 
Corneal perforation  1  1/2067 (0.05%) 
Retinal artery occlusion  1  1/2067 (0.05%) 
Gastrointestinal disorders   
Diverticular perforation  1  11/2067 (0.53%) 
Abdominal pain  1  6/2067 (0.29%) 
Gastritis  1  5/2067 (0.24%) 
Pancreatitis  1  5/2067 (0.24%) 
Vomiting  1  4/2067 (0.19%) 
Colitis  1  3/2067 (0.15%) 
Crohn's disease  1  3/2067 (0.15%) 
Diarrhoea  1  3/2067 (0.15%) 
Gastrointestinal haemorrhage  1  3/2067 (0.15%) 
Irritable bowel syndrome  1  3/2067 (0.15%) 
Large intestine perforation  1  3/2067 (0.15%) 
Small intestinal obstruction  1  3/2067 (0.15%) 
Abdominal pain upper  1  2/2067 (0.10%) 
Colitis ischaemic  1  2/2067 (0.10%) 
Diverticulum intestinal haemorrhagic  1  2/2067 (0.10%) 
Duodenal ulcer haemorrhage  1  2/2067 (0.10%) 
Gastric ulcer  1  2/2067 (0.10%) 
Gastric ulcer haemorrhage  1  2/2067 (0.10%) 
Gastritis erosive  1  2/2067 (0.10%) 
Haemorrhoids  1  2/2067 (0.10%) 
Ileus  1  2/2067 (0.10%) 
Mallory-weiss syndrome  1  2/2067 (0.10%) 
Abdominal adhesions  1  1/2067 (0.05%) 
Abdominal distension  1  1/2067 (0.05%) 
Abdominal wall haematoma  1  1/2067 (0.05%) 
Anal fissure  1  1/2067 (0.05%) 
Ascites  1  1/2067 (0.05%) 
Colitis ulcerative  1  1/2067 (0.05%) 
Diverticulum  1  1/2067 (0.05%) 
Diverticulum intestinal  1  1/2067 (0.05%) 
Duodenal ulcer  1  1/2067 (0.05%) 
Dyspepsia  1  1/2067 (0.05%) 
Enterocutaneous fistula  1  1/2067 (0.05%) 
Erosive duodenitis  1  1/2067 (0.05%) 
Food poisoning  1  1/2067 (0.05%) 
Gastric disorder  1  1/2067 (0.05%) 
Gastric perforation  1  1/2067 (0.05%) 
Gastrointestinal erosion  1  1/2067 (0.05%) 
Gastrointestinal necrosis  1  1/2067 (0.05%) 
Gastrooesophageal reflux disease  1  1/2067 (0.05%) 
Haemorrhoidal haemorrhage  1  1/2067 (0.05%) 
Ileal perforation  1  1/2067 (0.05%) 
Inguinal hernia  1  1/2067 (0.05%) 
Intestinal ischaemia  1  1/2067 (0.05%) 
Intestinal perforation  1  1/2067 (0.05%) 
Intussusception  1  1/2067 (0.05%) 
Large intestinal ulcer  1  1/2067 (0.05%) 
Nausea  1  1/2067 (0.05%) 
Oedematous pancreatitis  1  1/2067 (0.05%) 
Oesophagitis  1  1/2067 (0.05%) 
Pancreatitis acute  1  1/2067 (0.05%) 
Peptic ulcer perforation  1  1/2067 (0.05%) 
Poor dental condition  1  1/2067 (0.05%) 
Rectal haemorrhage  1  1/2067 (0.05%) 
Small intestinal perforation  1  1/2067 (0.05%) 
Stomatitis haemorrhagic  1  1/2067 (0.05%) 
Umbilical hernia  1  1/2067 (0.05%) 
Upper gastrointestinal haemorrhage  1  1/2067 (0.05%) 
General disorders   
Non-cardiac chest pain  1  11/2067 (0.53%) 
Device dislocation  1  6/2067 (0.29%) 
Chest pain  1  3/2067 (0.15%) 
Multi-organ failure  1  3/2067 (0.15%) 
Surgical failure  1  3/2067 (0.15%) 
Death  1  2/2067 (0.10%) 
Impaired healing  1  2/2067 (0.10%) 
Cyst  1  1/2067 (0.05%) 
Drug withdrawal syndrome  1  1/2067 (0.05%) 
Effusion  1  1/2067 (0.05%) 
Oedema peripheral  1  1/2067 (0.05%) 
Sudden death  1  1/2067 (0.05%) 
Systemic inflammatory response syndrome  1  1/2067 (0.05%) 
Hepatobiliary disorders   
Cholelithiasis  1  10/2067 (0.48%) 
Cholecystitis  1  4/2067 (0.19%) 
Biliary colic  1  2/2067 (0.10%) 
Cholecystitis acute  1  2/2067 (0.10%) 
Bile duct stone  1  1/2067 (0.05%) 
Cholestasis  1  1/2067 (0.05%) 
Hepatic steatosis  1  1/2067 (0.05%) 
Ischaemic hepatitis  1  1/2067 (0.05%) 
Immune system disorders   
Anaphylactic reaction  1  2/2067 (0.10%) 
Allergy to arthropod sting  1  1/2067 (0.05%) 
Anaphylactic shock  1  1/2067 (0.05%) 
Infections and infestations   
Pneumonia  1  70/2067 (3.39%) 
Cellulitis  1  57/2067 (2.76%) 
Appendicitis  1  11/2067 (0.53%) 
Diverticulitis  1  10/2067 (0.48%) 
Gastroenteritis  1  10/2067 (0.48%) 
Sepsis  1  10/2067 (0.48%) 
Urinary tract infection  1  10/2067 (0.48%) 
Arthritis bacterial  1  8/2067 (0.39%) 
Bronchitis  1  7/2067 (0.34%) 
Herpes zoster  1  7/2067 (0.34%) 
Abscess limb  1  6/2067 (0.29%) 
Erysipelas  1  6/2067 (0.29%) 
Septic shock  1  6/2067 (0.29%) 
Bronchopneumonia  1  5/2067 (0.24%) 
Postoperative wound infection  1  5/2067 (0.24%) 
Pyelonephritis  1  5/2067 (0.24%) 
Infectious pleural effusion  1  4/2067 (0.19%) 
Peritonitis  1  4/2067 (0.19%) 
Pulmonary tuberculosis  1  4/2067 (0.19%) 
Staphylococcal infection  1  4/2067 (0.19%) 
Wound infection  1  4/2067 (0.19%) 
Abdominal abscess  1  3/2067 (0.15%) 
Bursitis infective  1  3/2067 (0.15%) 
Staphylococcal Clostridium difficile colitis  1  3/2067 (0.15%) 
Empyema  1  3/2067 (0.15%) 
Infective exacerbation of chronic obstructive airways disease  1  3/2067 (0.15%) 
Lung infection  1  3/2067 (0.15%) 
Necrotising fasciitis  1  3/2067 (0.15%) 
Osteomyelitis  1  3/2067 (0.15%) 
Pneumonia pneumococcal  1  3/2067 (0.15%) 
Pneumonia staphylococcal  1  3/2067 (0.15%) 
Post procedural infection  1  3/2067 (0.15%) 
Septic arthritis  1  3/2067 (0.15%) 
Staphylococcal sinusitis  1  3/2067 (0.15%) 
Subcutaneous abscess  1  3/2067 (0.15%) 
Wound infection staphylococcal  1  3/2067 (0.15%) 
Abdominal wall abscess  1  2/2067 (0.10%) 
Gastroenteritis viral  1  2/2067 (0.10%) 
Infective tenosynovitis  1  2/2067 (0.10%) 
Influenza  1  2/2067 (0.10%) 
Liver abscess  1  2/2067 (0.10%) 
Localised infection  1  2/2067 (0.10%) 
Lower respiratory tract infection  1  2/2067 (0.10%) 
Pelvic inflammatory disease  1  2/2067 (0.10%) 
Pericolic abscess  1  2/2067 (0.10%) 
Peritonitis bacterial  1  2/2067 (0.10%) 
Pneumonia haemophilus  1  2/2067 (0.10%) 
Pneumonia streptococcal  1  2/2067 (0.10%) 
Pulmonary sepsis  1  2/2067 (0.10%) 
Respiratory tract infection  1  2/2067 (0.10%) 
Salmonellosis  1  2/2067 (0.10%) 
Septic arthritis streptococcal  1  2/2067 (0.10%) 
Sinusitis fungal  1  2/2067 (0.10%) 
Soft tissue infection  1  2/2067 (0.10%) 
Staphylococcal abscess  1  2/2067 (0.10%) 
Tooth infection  1  2/2067 (0.10%) 
Tuberculous pleurisy  1  2/2067 (0.10%) 
Upper respiratory tract infection  1  2/2067 (0.10%) 
Urosepsis  1  2/2067 (0.10%) 
Viral infection  1  2/2067 (0.10%) 
Abscess  1  1/2067 (0.05%) 
Abscess oral  1  1/2067 (0.05%) 
Abscess soft tissue  1  1/2067 (0.05%) 
Acquired immunodeficiency syndrome  1  1/2067 (0.05%) 
Alcaligenes infection  1  1/2067 (0.05%) 
Anal abscess  1  1/2067 (0.05%) 
Appendiceal abscess  1  1/2067 (0.05%) 
Arthritis infective  1  1/2067 (0.05%) 
Bacteraemia  1  1/2067 (0.05%) 
Bacterial sepsis  1  1/2067 (0.05%) 
Biliary sepsis  1  1/2067 (0.05%) 
Breast abscess  1  1/2067 (0.05%) 
Bronchitis bacterial  1  1/2067 (0.05%) 
Bronchitis viral  1  1/2067 (0.05%) 
Bursitis infective  1  1/2067 (0.05%) 
Campylobacter gastroenteritis  1  1/2067 (0.05%) 
Cellulitis gangrenous  1  1/2067 (0.05%) 
Cellulitis staphylococcal  1  1/2067 (0.05%) 
Central nervous system infection  1  1/2067 (0.05%) 
Chronic tonsillitis  1  1/2067 (0.05%) 
Encephalitis viral  1  1/2067 (0.05%) 
Endocarditis bacterial  1  1/2067 (0.05%) 
Endocarditis enterococcal  1  1/2067 (0.05%) 
Enterocolitis infectious  1  1/2067 (0.05%) 
Escherichia infection  1  1/2067 (0.05%) 
Escherichia sepsis  1  1/2067 (0.05%) 
Escherichia urinary tract infection  1  1/2067 (0.05%) 
Extradural abscess  1  1/2067 (0.05%) 
Fallopian tube abscess  1  1/2067 (0.05%) 
Furuncle  1  1/2067 (0.05%) 
Gingival infection  1  1/2067 (0.05%) 
Haematoma infection  1  1/2067 (0.05%) 
Hepatitis B  1  1/2067 (0.05%) 
Hepatitis E  1  1/2067 (0.05%) 
Herpes zoster ophthalmic  1  1/2067 (0.05%) 
Incision site cellulitis  1  1/2067 (0.05%) 
Incision site infection  1  1/2067 (0.05%) 
Infected bites  1  1/2067 (0.05%) 
Infected skin ulcer  1  1/2067 (0.05%) 
Infection  1  1/2067 (0.05%) 
Keratitis herpetic  1  1/2067 (0.05%) 
Klebsiella sepsis  1  1/2067 (0.05%) 
Lobar pneumonia  1  1/2067 (0.05%) 
Meningitis aseptic  1  1/2067 (0.05%) 
Mycobacterium avium complex infection  1  1/2067 (0.05%) 
Nasal abscess  1  1/2067 (0.05%) 
Neutropenic sepsis  1  1/2067 (0.05%) 
Osteomyelitis chronic  1  1/2067 (0.05%) 
Paronychia  1  1/2067 (0.05%) 
Parotitis  1  1/2067 (0.05%) 
Perineal infection  1  1/2067 (0.05%) 
Periorbital cellulitis  1  1/2067 (0.05%) 
Peritoneal abscess  1  1/2067 (0.05%) 
Peritonsillar abscess  1  1/2067 (0.05%) 
Pharyngitis streptococcal  1  1/2067 (0.05%) 
Pneumococcal sepsis  1  1/2067 (0.05%) 
Pneumonia bacterial  1  1/2067 (0.05%) 
Pneumonia blastomyces  1  1/2067 (0.05%) 
Pneumonia viral  1  1/2067 (0.05%) 
Post procedural cellulitis  1  1/2067 (0.05%) 
Prostatic abscess  1  1/2067 (0.05%) 
Proteus infection  1  1/2067 (0.05%) 
Pseudomonal bacteraemia  1  1/2067 (0.05%) 
Pseudomonas infection  1  1/2067 (0.05%) 
Psoas abscess  1  1/2067 (0.05%) 
Pyelonephritis acute  1  1/2067 (0.05%) 
Rectal abscess  1  1/2067 (0.05%) 
Renal abscess  1  1/2067 (0.05%) 
Sialoadenitis  1  1/2067 (0.05%) 
Skin infection  1  1/2067 (0.05%) 
Staphylococcal sepsis  1  1/2067 (0.05%) 
Streptococcal sepsis  1  1/2067 (0.05%) 
Systemic candida  1  1/2067 (0.05%) 
Tongue abscess  1  1/2067 (0.05%) 
Tracheitis  1  1/2067 (0.05%) 
Tuberculosis  1  1/2067 (0.05%) 
Varicella  1  1/2067 (0.05%) 
Viral diarrhoea  1  1/2067 (0.05%) 
Wound infection bacterial  1  1/2067 (0.05%) 
Injury, poisoning and procedural complications   
Ankle fracture  1  8/2067 (0.39%) 
Humerus fracture  1  7/2067 (0.34%) 
Femur fracture  1  5/2067 (0.24%) 
Pelvic fracture  1  5/2067 (0.24%) 
Femoral neck fracture  1  4/2067 (0.19%) 
Joint dislocation  1  4/2067 (0.19%) 
Upper limb fracture  1  4/2067 (0.19%) 
Wound dehiscence  1  4/2067 (0.19%) 
Laceration  1  3/2067 (0.15%) 
Lower limb fracture  1  3/2067 (0.15%) 
Spinal compression fracture  1  3/2067 (0.15%) 
Comminuted fracture  1  2/2067 (0.10%) 
Foot fracture  1  2/2067 (0.10%) 
Incisional hernia  1  2/2067 (0.10%) 
Intentional overdose  1  2/2067 (0.10%) 
Meniscus injury  1  2/2067 (0.10%) 
Overdose  1  2/2067 (0.10%) 
Postoperative ileus  1  2/2067 (0.10%) 
Postoperative wound complication  1  2/2067 (0.10%) 
Procedural pain  1  2/2067 (0.10%) 
Radius fracture  1  2/2067 (0.10%) 
Seroma  1  2/2067 (0.10%) 
Thoracic vertebral fracture  1  2/2067 (0.10%) 
Tibia fracture  1  2/2067 (0.10%) 
Ulna fracture  1  2/2067 (0.10%) 
Accidental overdose  1  1/2067 (0.05%) 
Bone fragmentation  1  1/2067 (0.05%) 
Burns second degree  1  1/2067 (0.05%) 
Carotid artery restenosis  1  1/2067 (0.05%) 
Cervical vertebral fracture  1  1/2067 (0.05%) 
Hip fracture  1  10/2067 (0.48%) 
Contusion  1  1/2067 (0.05%) 
Face injury  1  1/2067 (0.05%) 
Fall  1  1/2067 (0.05%) 
Fracture displacement  1  1/2067 (0.05%) 
Head injury  1  1/2067 (0.05%) 
Infusion related reaction  1  1/2067 (0.05%) 
Joint injury  1  1/2067 (0.05%) 
Lumbar vertebral fracture  1  1/2067 (0.05%) 
Multiple fractures  1  1/2067 (0.05%) 
Multiple injuries  1  1/2067 (0.05%) 
Patella fracture  1  1/2067 (0.05%) 
Periprosthetic fracture  1  1/2067 (0.05%) 
Post procedural haematoma  1  1/2067 (0.05%) 
Post-traumatic pain  1  1/2067 (0.05%) 
Pubis fracture  1  1/2067 (0.05%) 
Rib fracture  1  1/2067 (0.05%) 
Road traffic accident  1  1/2067 (0.05%) 
Skull fracture  1  1/2067 (0.05%) 
Spinal column injury  1  1/2067 (0.05%) 
Spinal cord injury  1  1/2067 (0.05%) 
Subcutaneous haematoma  1  1/2067 (0.05%) 
Subdural haematoma  1  1/2067 (0.05%) 
Synovial rupture  1  1/2067 (0.05%) 
Tendon rupture  1  1/2067 (0.05%) 
Tracheal haemorrhage  1  1/2067 (0.05%) 
Tracheostomy malfunction  1  1/2067 (0.05%) 
Wound  1  1/2067 (0.05%) 
Investigations   
Hepatic enzyme increased  1  1/2067 (0.05%) 
Metabolism and nutrition disorders   
Dehydration  1  3/2067 (0.15%) 
Diabetes mellitus inadequate control  1  1/2067 (0.05%) 
Diabetic ketoacidosis  1  1/2067 (0.05%) 
Hypokalaemia  1  1/2067 (0.05%) 
Type 1 diabetes mellitus  1  1/2067 (0.05%) 
Musculoskeletal and connective tissue disorders   
Osteoarthritis  1  25/2067 (1.21%) 
Intervertebral disc protrusion  1  7/2067 (0.34%) 
Foot deformity  1  5/2067 (0.24%) 
Back pain  1  4/2067 (0.19%) 
Osteonecrosis  1  4/2067 (0.19%) 
Rheumatoid arthritis  1  4/2067 (0.19%) 
Bursitis  1  3/2067 (0.15%) 
Intervertebral disc degeneration  1  3/2067 (0.15%) 
Musculoskeletal chest pain  1  3/2067 (0.15%) 
Osteoporotic fracture  1  3/2067 (0.15%) 
Spinal column stenosis  1  3/2067 (0.15%) 
Spinal osteoarthritis  1  3/2067 (0.15%) 
Arthralgia  1  2/2067 (0.10%) 
Haemarthrosis  1  2/2067 (0.10%) 
Synovitis  1  2/2067 (0.10%) 
Acquired claw toe  1  1/2067 (0.05%) 
Arthritis  1  1/2067 (0.05%) 
Arthrofibrosis  1  1/2067 (0.05%) 
Arthropathy  1  1/2067 (0.05%) 
Cervical spinal stenosis  1  1/2067 (0.05%) 
Chondrocalcinosis pyrophosphate  1  1/2067 (0.05%) 
Dupuytren’s contracture  1  1/2067 (0.05%) 
Fistula  1  1/2067 (0.05%) 
Fracture malunion  1  1/2067 (0.05%) 
Joint contracture  1  1/2067 (0.05%) 
Joint instability  1  1/2067 (0.05%) 
Lumbar spinal stenosis  1  1/2067 (0.05%) 
Muscular weakness  1  1/2067 (0.05%) 
Musculoskeletal pain  1  1/2067 (0.05%) 
Osteitis  1  1/2067 (0.05%) 
Patellofemoral pain syndrome  1  1/2067 (0.05%) 
Pathological fracture  1  1/2067 (0.05%) 
Periarthritis  1  1/2067 (0.05%) 
Pseudarthrosis  1  1/2067 (0.05%) 
Rotator cuff syndrome  1  1/2067 (0.05%) 
Scoliosis  1  1/2067 (0.05%) 
Spinal disorder  1  1/2067 (0.05%) 
Spondylolisthesis  1  1/2067 (0.05%) 
Tendonitis  1  1/2067 (0.05%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Basal cell carcinoma  1  5/2067 (0.24%) 
Invasive ductal breast carcinoma  1  5/2067 (0.24%) 
Squamous cell carcinoma of skin  1  5/2067 (0.24%) 
Uterine leiomyoma  1  4/2067 (0.19%) 
Adenocarcinoma of colon  1  3/2067 (0.15%) 
Ovarian adenoma  1  3/2067 (0.15%) 
Prostate cancer  1  3/2067 (0.15%) 
Breast cancer metastatic  1  2/2067 (0.10%) 
Carcinoid tumour of the gastrointestinal tract  1  2/2067 (0.10%) 
Cervix carcinoma stage 0  1  2/2067 (0.10%) 
Diffuse large b-cell lymphoma  1  2/2067 (0.10%) 
Lung adenocarcinoma stage II  1  2/2067 (0.10%) 
Lung adenocarcinoma stage III  1  2/2067 (0.10%) 
Lung squamous cell carcinoma stage III  1  2/2067 (0.10%) 
Myelodysplastic syndrome  1  2/2067 (0.10%) 
Pancreatic carcinoma metastatic  1  2/2067 (0.10%) 
Small cell lung cancer metastatic  1  2/2067 (0.10%) 
Acute myeloid leukaemia  1  1/2067 (0.05%) 
Adenocarcinoma gastric  1  1/2067 (0.05%) 
Astrocytoma malignant  1  1/2067 (0.05%) 
Basosquamous carcinoma of skin  1  1/2067 (0.05%) 
Benign breast neoplasm  1  1/2067 (0.05%) 
Benign neoplasm of thyroid gland  1  1/2067 (0.05%) 
Benign renal neoplasm  1  1/2067 (0.05%) 
Bladder cancer  1  1/2067 (0.05%) 
Bladder transitional cell carcinoma stage 0  1  1/2067 (0.05%) 
Bowen's disease  1  1/2067 (0.05%) 
Breast cancer  1  1/2067 (0.05%) 
Breast cancer stage III  1  1/2067 (0.05%) 
Chronic lymphocytic leukaemia  1  1/2067 (0.05%) 
Colon adenoma  1  1/2067 (0.05%) 
Colon cancer stage I  1  1/2067 (0.05%) 
Colon cancer stage II  1  1/2067 (0.05%) 
Dermatofibrosarcoma protuberans  1  1/2067 (0.05%) 
Endometrial adenocarcinoma  1  1/2067 (0.05%) 
Fibrosarcoma  1  1/2067 (0.05%) 
Gastrointestinal cancer metastatic  1  1/2067 (0.05%) 
Glioblastoma  1  1/2067 (0.05%) 
Hepatic neoplasm  1  1/2067 (0.05%) 
Intraductal papillary mucinous neoplasm  1  1/2067 (0.05%) 
Intraductal proliferative breast lesion  1  1/2067 (0.05%) 
Large intestine benign neoplasm  1  1/2067 (0.05%) 
Lung adenocarcinoma  1  1/2067 (0.05%) 
Lung adenocarcinoma metastatic  1  1/2067 (0.05%) 
Lung adenocarcinoma stage I  1  1/2067 (0.05%) 
Lung squamous cell carcinoma metastatic  1  1/2067 (0.05%) 
Lung squamous cell carcinoma stage I  1  1/2067 (0.05%) 
Malignant anorectal neoplasm  1  1/2067 (0.05%) 
Malignant melanoma in situ  1  1/2067 (0.05%) 
Malignant neoplasm of unknown primary site  1  1/2067 (0.05%) 
Meningioma benign  1  1/2067 (0.05%) 
Metastases to bone  1  1/2067 (0.05%) 
Nasal cavity cancer  1  1/2067 (0.05%) 
Non-hodgkin's lymphoma  1  1/2067 (0.05%) 
Ocular cancer metastatic  1  1/2067 (0.05%) 
Oesophageal carcinoma  1  1/2067 (0.05%) 
Ovarian epithelial cancer stage III  1  1/2067 (0.05%) 
Ovarian germ cell teratoma benign  1  1/2067 (0.05%) 
Post transplant lymphoproliferative disorder  1  1/2067 (0.05%) 
Prostate cancer metastatic  1  1/2067 (0.05%) 
Prostate cancer stage I  1  1/2067 (0.05%) 
Prostate cancer stage II  1  1/2067 (0.05%) 
Prostate cancer stage III  1  1/2067 (0.05%) 
Sarcoma uterus  1  1/2067 (0.05%) 
Spindle cell sarcoma  1  1/2067 (0.05%) 
Squamous cell carcinoma of lung  1  1/2067 (0.05%) 
Squamous cell carcinoma of pharynx  1  1/2067 (0.05%) 
Squamous cell carcinoma of the cervix  1  1/2067 (0.05%) 
Squamous cell carcinoma of the tongue  1  1/2067 (0.05%) 
Transitional cell carcinoma  1  1/2067 (0.05%) 
Uterine cancer  1  1/2067 (0.05%) 
Nervous system disorders   
Transient ischaemic attack  1  9/2067 (0.44%) 
Syncope  1  6/2067 (0.29%) 
Cerebrovascular accident  1  5/2067 (0.24%) 
Carotid artery stenosis  1  4/2067 (0.19%) 
Sciatica  1  3/2067 (0.15%) 
Cerebral infarction  1  2/2067 (0.10%) 
Cerebral ischaemia  1  2/2067 (0.10%) 
Headache  1  2/2067 (0.10%) 
Intracranial aneurysm  1  2/2067 (0.10%) 
Ischaemic stroke  1  2/2067 (0.10%) 
Transient global amnesia  1  2/2067 (0.10%) 
Viith nerve paralysis  1  2/2067 (0.10%) 
Aphasia  1  1/2067 (0.05%) 
Balance disorder  1  1/2067 (0.05%) 
Carotid artery occlusion  1  1/2067 (0.05%) 
Cerebral haemorrhage  1  1/2067 (0.05%) 
Convulsion  1  1/2067 (0.05%) 
Dementia  1  1/2067 (0.05%) 
Dizziness  1  1/2067 (0.05%) 
Dysarthria  1  1/2067 (0.05%) 
Facial neuralgia  1  1/2067 (0.05%) 
Grand mal convulsion  1  1/2067 (0.05%) 
Haemorrhagic stroke  1  1/2067 (0.05%) 
Hypoglycaemic coma  1  1/2067 (0.05%) 
Hypoxic-ischaemic encephalopathy  1  1/2067 (0.05%) 
Intercostal neuralgia  1  1/2067 (0.05%) 
Ischaemic cerebral infarction  1  1/2067 (0.05%) 
Lacunar infarction  1  1/2067 (0.05%) 
Lumbar radiculopathy  1  1/2067 (0.05%) 
Meralgia paraesthetica  1  1/2067 (0.05%) 
Migraine  1  1/2067 (0.05%) 
Migraine with aura  1  1/2067 (0.05%) 
Monoparesis  1  1/2067 (0.05%) 
Multiple sclerosis relapse  1  1/2067 (0.05%) 
Neuropathy peripheral  1  1/2067 (0.05%) 
Normal pressure hydrocephalus  1  1/2067 (0.05%) 
Parkinson's disease  1  1/2067 (0.05%) 
Perineurial cyst  1  1/2067 (0.05%) 
Presyncope  1  1/2067 (0.05%) 
Ruptured cerebral aneurysm  1  1/2067 (0.05%) 
Spinal claudication  1  1/2067 (0.05%) 
Subarachnoid haemorrhage  1  1/2067 (0.05%) 
Thalamus haemorrhage  1  1/2067 (0.05%) 
Pregnancy, puerperium and perinatal conditions   
Abortion spontaneous  1  4/2067 (0.19%) 
Pregnancy  1  1/2067 (0.05%) 
Psychiatric disorders   
Depression  1  4/2067 (0.19%) 
Completed suicide  1  2/2067 (0.10%) 
Mental status changes  1  2/2067 (0.10%) 
Suicide attempt  1  2/2067 (0.10%) 
Abnormal behaviour  1  1/2067 (0.05%) 
Alcohol abuse  1  1/2067 (0.05%) 
Anxiety  1  1/2067 (0.05%) 
Bipolar disorder  1  1/2067 (0.05%) 
Bipolar I disorder  1  1/2067 (0.05%) 
Conversion disorder  1  1/2067 (0.05%) 
Drug dependence  1  1/2067 (0.05%) 
Schizophrenia, paranoid type  1  1/2067 (0.05%) 
Somatoform disorder neurologic  1  1/2067 (0.05%) 
Renal and urinary disorders   
Nephrolithiasis  1  12/2067 (0.58%) 
Renal failure acute  1  7/2067 (0.34%) 
Calculus ureteric  1  4/2067 (0.19%) 
Renal failure  1  3/2067 (0.15%) 
Calculus urinary  1  2/2067 (0.10%) 
Hydronephrosis  1  1/2067 (0.05%) 
Incontinence  1  1/2067 (0.05%) 
Mesangioproliferative glomerulonephritis  1  1/2067 (0.05%) 
Obstructive uropathy  1  1/2067 (0.05%) 
Postrenal failure  1  1/2067 (0.05%) 
Renal mass  1  1/2067 (0.05%) 
Reproductive system and breast disorders   
Ovarian cyst  1  4/2067 (0.19%) 
Uterine prolapse  1  4/2067 (0.19%) 
Menorrhagia  1  2/2067 (0.10%) 
Adnexa uteri cyst  1  1/2067 (0.05%) 
Adnexa uteri mass  1  1/2067 (0.05%) 
Cervical dysplasia  1  1/2067 (0.05%) 
Cervical polyp  1  1/2067 (0.05%) 
Endometrial hyperplasia  1  1/2067 (0.05%) 
Endometriosis  1  1/2067 (0.05%) 
Fibrocystic breast disease  1  1/2067 (0.05%) 
Postmenopausal haemorrhage 1  1  1/2067 (0.05%) 
Prostatitis  1  1/2067 (0.05%) 
Uterine fibrosis  1  1/2067 (0.05%) 
Uterine polyp  1  1/2067 (0.05%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism  1  15/2067 (0.73%) 
Chronic obstructive pulmonary disease  1  7/2067 (0.34%) 
Pleural effusion  1  7/2067 (0.34%) 
Interstitial lung disease  1  5/2067 (0.24%) 
Respiratory failure  1  5/2067 (0.24%) 
Acute respiratory distress syndrome  1  3/2067 (0.15%) 
Asthma  1  3/2067 (0.15%) 
Rheumatoid lung  1  3/2067 (0.15%) 
Dyspnoea  1  2/2067 (0.10%) 
Pneumonia aspiration  1  2/2067 (0.10%) 
Acute interstitial pneumonitis  1  1/2067 (0.05%) 
Alveolitis  1  1/2067 (0.05%) 
Bronchiectasis  1  1/2067 (0.05%) 
Bronchopleural fistula  1  1/2067 (0.05%) 
Bronchopneumopathy  1  1/2067 (0.05%) 
Epistaxis  1  1/2067 (0.05%) 
Haemoptysis  1  1/2067 (0.05%) 
Haemothorax  1  1/2067 (0.05%) 
Pleurisy  1  1/2067 (0.05%) 
Pneumothorax  1  1/2067 (0.05%) 
Pulmonary fibrosis  1  1/2067 (0.05%) 
Pulmonary mass  1  1/2067 (0.05%) 
Pulmonary oedema  1  1/2067 (0.05%) 
Respiratory distress  1  1/2067 (0.05%) 
Rhinitis allergic  1  1/2067 (0.05%) 
Sleep apnoea syndrome  1  1/2067 (0.05%) 
Skin and subcutaneous tissue disorders   
Acute febrile neutrophilic dermatosis  1  2/2067 (0.10%) 
Leukocytoclastic vasculitis  1  2/2067 (0.10%) 
Skin ulcer  1  2/2067 (0.10%) 
Dry gangrene  1  1/2067 (0.05%) 
Mucocutaneous rash  1  1/2067 (0.05%) 
Surgical and medical procedures   
Removal of internal fixation 1  1  1/2067 (0.05%) 
Vascular disorders   
Deep vein thrombosis  1  14/2067 (0.68%) 
Hypertension  1  8/2067 (0.39%) 
Aortic aneurysm  1  4/2067 (0.19%) 
Haematoma  1  2/2067 (0.10%) 
Hypertensive crisis  1  2/2067 (0.10%) 
Orthostatic hypotension  1  2/2067 (0.10%) 
Phlebitis  1  2/2067 (0.10%) 
Aortic stenosis  1  1/2067 (0.05%) 
Arteriosclerosis  1  1/2067 (0.05%) 
Arteritis  1  1/2067 (0.05%) 
Essential hypertension  1  1/2067 (0.05%) 
Hypovolaemic shock  1  1/2067 (0.05%) 
Peripheral vascular disorder  1  1/2067 (0.05%) 
Post thrombotic syndrome  1  1/2067 (0.05%) 
Thrombosed varicose vein  1  1/2067 (0.05%) 
Thrombosis  1  1/2067 (0.05%) 
Vascular rupture  1  1/2067 (0.05%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tocilizumab
Affected / at Risk (%)
Total   1836/2067 (88.82%) 
Gastrointestinal disorders   
Diarrhoea  1  358/2067 (17.32%) 
Nausea  1  261/2067 (12.63%) 
Dyspepsia  1  189/2067 (9.14%) 
Abdominal pain upper  1  151/2067 (7.31%) 
Gastritis  1  149/2067 (7.21%) 
Abdominal pain  1  120/2067 (5.81%) 
Vomiting  1  114/2067 (5.52%) 
Gastrooesophageal reflux disease  1  113/2067 (5.47%) 
Constipation  1  107/2067 (5.18%) 
General disorders   
Oedema peripheral  1  183/2067 (8.85%) 
Fatigue  1  128/2067 (6.19%) 
Infections and infestations   
Upper respiratory tract infection  1  616/2067 (29.80%) 
Nasopharyngitis  1  495/2067 (23.95%) 
Urinary tract infection  1  420/2067 (20.32%) 
Bronchitis  1  405/2067 (19.59%) 
Sinusitis  1  326/2067 (15.77%) 
Influenza  1  231/2067 (11.18%) 
Gastroenteritis  1  213/2067 (10.30%) 
Pharyngitis  1  180/2067 (8.71%) 
Herpes zoster  1  129/2067 (6.24%) 
Cellulitis  1  127/2067 (6.14%) 
Gastroenteritis viral  1  122/2067 (5.90%) 
Injury, poisoning and procedural complications   
Contusion  1  149/2067 (7.21%) 
Investigations   
Transaminases increased  1  136/2067 (6.58%) 
Alanine aminotransferase increased  1  111/2067 (5.37%) 
Metabolism and nutrition disorders   
Hypercholesterolaemia  1  170/2067 (8.22%) 
Musculoskeletal and connective tissue disorders   
Rheumatoid arthritis  1  322/2067 (15.58%) 
Back pain  1  294/2067 (14.22%) 
Arthralgia  1  201/2067 (9.72%) 
Osteoarthritis  1  131/2067 (6.34%) 
Pain in extremity  1  131/2067 (6.34%) 
Bursitis  1  117/2067 (5.66%) 
Musculoskeletal pain  1  113/2067 (5.47%) 
Nervous system disorders   
Headache  1  289/2067 (13.98%) 
Dizziness  1  161/2067 (7.79%) 
Psychiatric disorders   
Insomnia  1  136/2067 (6.58%) 
Depression  1  122/2067 (5.90%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  199/2067 (9.63%) 
Oropharyngeal pain  1  115/2067 (5.56%) 
Skin and subcutaneous tissue disorders   
Rash  1  181/2067 (8.76%) 
Vascular disorders   
Hypertension  1  411/2067 (19.88%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800 821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00720798     History of Changes
Other Study ID Numbers: WA18696
First Submitted: July 22, 2008
First Posted: July 23, 2008
Results First Submitted: June 10, 2014
Results First Posted: September 30, 2014
Last Update Posted: September 30, 2014