Trial Outcomes & Findings for A Study of Tocilizumab With or Without Methotrexate in Patients With Rheumatoid Arthritis. (NCT NCT01010503)
NCT ID: NCT01010503
Last Updated: 2014-08-13
Results Overview
Adherence rate to original treatment according to the protocol included all participants that received the study drug beginning from Week 8 and remaining until the end of the study. This number represents participants with no changes in treatment protocol, participants with treatment discontinuation, and participants with dose reduction, but not participants that withdrew from the study prematurely.
COMPLETED
PHASE4
32 participants
Week 24
2014-08-13
Participant Flow
Participant milestones
| Measure |
Tocilizumab 8 Milligrams Per Kilogram (mg/kg)
Participants received tocilizumab 8 mg/kg intravenously (IV) once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Tocilizumab 8 Milligrams Per Kilogram (mg/kg)
Participants received tocilizumab 8 mg/kg intravenously (IV) once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
A Study of Tocilizumab With or Without Methotrexate in Patients With Rheumatoid Arthritis.
Baseline characteristics by cohort
| Measure |
Tocilizumab 8 mg/kg
n=32 Participants
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
|
|---|---|
|
Age, Continuous
|
52.38 years
STANDARD_DEVIATION 12.05 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Slovakia
|
32 participants
n=5 Participants
|
|
Disease Duration
|
11.97 years
STANDARD_DEVIATION 10.55 • n=5 Participants
|
|
Disease Phase/Stage
Phase/Stage I
|
4 participants
n=5 Participants
|
|
Disease Phase/Stage
Phase/Stage II
|
12 participants
n=5 Participants
|
|
Disease Phase/Stage
Phase/Stage III
|
12 participants
n=5 Participants
|
|
Disease Phase/Stage
Phase/Stage IV
|
4 participants
n=5 Participants
|
|
Functional Class of Disease
Class I
|
0 participants
n=5 Participants
|
|
Functional Class of Disease
Class II
|
10 participants
n=5 Participants
|
|
Functional Class of Disease
Class III
|
22 participants
n=5 Participants
|
|
Functional Class of Disease
Class IV
|
0 participants
n=5 Participants
|
|
C-Reactive Protein (CRP)
|
17.84 mg/L
STANDARD_DEVIATION 21.30 • n=5 Participants
|
|
Erythrocyte Sedimentation Rate (ESR)
|
55.81 mm/hr
STANDARD_DEVIATION 25.05 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: Intent-to-treat population (ITT), all enrolled participants who received at least one dose of study drug
Adherence rate to original treatment according to the protocol included all participants that received the study drug beginning from Week 8 and remaining until the end of the study. This number represents participants with no changes in treatment protocol, participants with treatment discontinuation, and participants with dose reduction, but not participants that withdrew from the study prematurely.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=32 Participants
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
|
|---|---|
|
Percentage of Participants Adherent to Original Treatment
|
93.75 percentage of participants
|
PRIMARY outcome
Timeframe: Weeks 0, 4, 8, 12, 16, 20, and 24Population: ITT Population
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=32 Participants
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
|
|---|---|
|
Percentage of Participants Receiving Less Than or Equal to (≤) 1 Dose of Study Drug Who Discontinued Treatment for Any Reason
|
3.13 percentage of participants
|
PRIMARY outcome
Timeframe: Weeks 0, 4, 8, 12, 16, 20, and 24Population: ITT Population
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=32 Participants
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
|
|---|---|
|
Percentage of Participants Receiving Greater Than (>) 1 Dose Who Discontinued Treatment for Any Reason
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Weeks 0, 4, 8, 12, 16, 20, and 24Population: ITT Population
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=32 Participants
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
|
|---|---|
|
Percentage of Participants Withdrawing From the Study Prematurely for Any Reason
|
6.25 percentage of participants
|
PRIMARY outcome
Timeframe: Weeks 0, 4, 8, 12, 16, and 20Population: ITT Population
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=32 Participants
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
|
|---|---|
|
Percentage of Participants With Dose Reduction to Tocilizumab 4 mg/kg
|
18.75 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 12, and 24Population: ITT population; n=number of participants assessed for the specified parameter at a given visit.
DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hr\]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2 equals (=) low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=32 Participants
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
|
|---|---|
|
Disease Activity Score Based on 28-Joint Count (DAS28)
Week 0 (n=32)
|
7.02 units on a scale
Standard Deviation 0.66
|
|
Disease Activity Score Based on 28-Joint Count (DAS28)
Week 4 (n=32)
|
4.30 units on a scale
Standard Deviation 1.04
|
|
Disease Activity Score Based on 28-Joint Count (DAS28)
Week 12 (n=30)
|
2.85 units on a scale
Standard Deviation 1.11
|
|
Disease Activity Score Based on 28-Joint Count (DAS28)
Week 24 (n=30)
|
2.57 units on a scale
Standard Deviation 0.91
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8, 12, 16, 20, and 24Population: ITT population; n=number of participants assessed for the specified parameter at a given visit.
Participants were asked to rate their pain using a 0 to 100 mm visual analog scale (VAS), where 0 mm = no pain and 100 mm = worst possible pain. The participant was asked to mark the line corresponding to their perceived level of pain and the distance in mm from the left edge of the scale was measured.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=32 Participants
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
|
|---|---|
|
Patient Global Assessment of Pain
Week 0 (n=32)
|
59.91 units on a scale
Standard Deviation 14.66
|
|
Patient Global Assessment of Pain
Week 4 (n=32)
|
36.31 units on a scale
Standard Deviation 17.10
|
|
Patient Global Assessment of Pain
Week 8 (n=30)
|
22.3 units on a scale
Standard Deviation 15.79
|
|
Patient Global Assessment of Pain
Week 12 (n=30)
|
17.30 units on a scale
Standard Deviation 14.00
|
|
Patient Global Assessment of Pain
Week 16 (n=30)
|
18.93 units on a scale
Standard Deviation 14.59
|
|
Patient Global Assessment of Pain
Week 20 (n=30)
|
16.73 units on a scale
Standard Deviation 15.11
|
|
Patient Global Assessment of Pain
Week 24 (n=30)
|
14.87 units on a scale
Standard Deviation 11.32
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8, 12, 16, 20, and 24Population: ITT population; n=number of participants assessed for the specified parameter at a given visit.
The participant's assessment of disease activity was performed using a 100 mm VAS ranging from no activity (0) to maximal activity (100). The participant was asked to mark the line corresponding to their perceived level of disease activity and the distance in mm from the left edge of the scale was measured.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=32 Participants
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
|
|---|---|
|
Patient Global Assessment of Disease Activity
Week 0 (n=32)
|
61.75 units on a scale
Standard Deviation 11.76
|
|
Patient Global Assessment of Disease Activity
Week 4 (n=32)
|
35.59 units on a scale
Standard Deviation 16.62
|
|
Patient Global Assessment of Disease Activity
Week 8 (n=30)
|
22.20 units on a scale
Standard Deviation 14.86
|
|
Patient Global Assessment of Disease Activity
Week 12 (n=30)
|
18.20 units on a scale
Standard Deviation 14.57
|
|
Patient Global Assessment of Disease Activity
Week 16 (n=30)
|
18.80 units on a scale
Standard Deviation 13.42
|
|
Patient Global Assessment of Disease Activity
Week 20 (n=30)
|
18.13 units on a scale
Standard Deviation 18.49
|
|
Patient Global Assessment of Disease Activity
Week 24 (n=30)
|
15.47 units on a scale
Standard Deviation 12.62
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8, 12, 16, 20, and 24Population: ITT population; n=number of participants assessed for the specified parameter at a given visit.
Physician's global assessment of disease activity was performed using a 100 mm VAS ranging from no arthritis activity (0) to maximal arthritis activity (100). The physician was asked to mark the line corresponding to their perceived level of the participant's disease activity and the distance in mm from the left edge of the scale was measured.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=32 Participants
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
|
|---|---|
|
Physician's Global Assessment of Disease Activity
Week 8 (n=30)
|
17.40 units on a scale
Standard Deviation 9.96
|
|
Physician's Global Assessment of Disease Activity
Week 12 (n=30)
|
14.20 units on a scale
Standard Deviation 9.93
|
|
Physician's Global Assessment of Disease Activity
Week 16 (n=30)
|
13.00 units on a scale
Standard Deviation 8.68
|
|
Physician's Global Assessment of Disease Activity
Week 20 (n=30)
|
12.77 units on a scale
Standard Deviation 10.17
|
|
Physician's Global Assessment of Disease Activity
Week 24 (n=30)
|
12.47 units on a scale
Standard Deviation 8.22
|
|
Physician's Global Assessment of Disease Activity
Week 0 (n=32)
|
59.63 units on a scale
Standard Deviation 7.89
|
|
Physician's Global Assessment of Disease Activity
Week 4 (n=32)
|
27.75 units on a scale
Standard Deviation 14.00
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8, 12, 16, 20, and 24Population: ITT population; n=number of participants assessed for the specified parameter at a given visit.
The following 28 joints were assessed by the physician for swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). Joints were rated as 0=not swollen or 1=swollen. The total number was calculated from all the joints for a maximum score of 28.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=32 Participants
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
|
|---|---|
|
Swollen Joint Count (SJC)
Week 8 (n=30)
|
7.00 swollen joints
Standard Deviation 6.52
|
|
Swollen Joint Count (SJC)
Week 12 (n=30)
|
5.33 swollen joints
Standard Deviation 6.47
|
|
Swollen Joint Count (SJC)
Week 16 (n=30)
|
5.33 swollen joints
Standard Deviation 6.33
|
|
Swollen Joint Count (SJC)
Week 20 (n=30)
|
4.20 swollen joints
Standard Deviation 5.088
|
|
Swollen Joint Count (SJC)
Week 24 (n=30)
|
4.00 swollen joints
Standard Deviation 5.24
|
|
Swollen Joint Count (SJC)
Week 0 (n=32)
|
26.66 swollen joints
Standard Deviation 7.11
|
|
Swollen Joint Count (SJC)
Week 4 (n=32)
|
12.03 swollen joints
Standard Deviation 8.24
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8, 12, 16, 20, and 24Population: ITT population; n=number of participants assessed for the specified parameter at a given visit.
The following 28 joints were assessed by the physician for tenderness: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). Joints were rated as 0=not tender or 1=tender. The total number was calculated from all the joints for a maximum score of 28.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=32 Participants
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
|
|---|---|
|
Tender Joint Count (TJC)
Week 0 (n=32)
|
16.16 tender joints
Standard Deviation 5.18
|
|
Tender Joint Count (TJC)
Week 4 (n=32)
|
5.53 tender joints
Standard Deviation 5.16
|
|
Tender Joint Count (TJC)
Week 8 (n=30)
|
1.97 tender joints
Standard Deviation 2.01
|
|
Tender Joint Count (TJC)
Week 12 (n=30)
|
1.30 tender joints
Standard Deviation 1.68
|
|
Tender Joint Count (TJC)
Week 16 (n=30)
|
1.00 tender joints
Standard Deviation 1.20
|
|
Tender Joint Count (TJC)
Week 20 (n=30)
|
0.83 tender joints
Standard Deviation 1.315
|
|
Tender Joint Count (TJC)
Week 24 (n=30)
|
0.63 tender joints
Standard Deviation 1.00
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 12, 20, and 24Population: TT population; n=number of participants assessed for the specified parameter at a given visit.
ESR indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=32 Participants
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
|
|---|---|
|
Erythrocyte Sedimentation Rate (ESR)
Week 0 (n=32)
|
55.81 mm/hr
Standard Deviation 25.05
|
|
Erythrocyte Sedimentation Rate (ESR)
Week 4 (n=32)
|
16.69 mm/hr
Standard Deviation 10.88
|
|
Erythrocyte Sedimentation Rate (ESR)
Week 12 (n=30)
|
15.23 mm/hr
Standard Deviation 14.78
|
|
Erythrocyte Sedimentation Rate (ESR)
Week 20 (n=30)
|
14.17 mm/hr
Standard Deviation 17.81
|
|
Erythrocyte Sedimentation Rate (ESR)
Week 24 (n=30)
|
11.00 mm/hr
Standard Deviation 7.94
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 12, 20, and 24Population: ITT population; n=number of participants assessed for the specified parameter at a given visit.
CRP is an acute phase protein. Levels of CRP increase with inflammation.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=32 Participants
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
|
|---|---|
|
C-Reactive Protein (CRP)
Week 0 (n=32)
|
17.84 mg/L
Standard Deviation 21.30
|
|
C-Reactive Protein (CRP)
Week 4 (n=32)
|
5.03 mg/L
Standard Deviation 6.07
|
|
C-Reactive Protein (CRP)
Week 12 (n=30)
|
5.54 mg/L
Standard Deviation 9.22
|
|
C-Reactive Protein (CRP)
Week 20 (n=30)
|
6.71 mg/L
Standard Deviation 13.9
|
|
C-Reactive Protein (CRP)
Week 24 (n=30)
|
2.97 mg/L
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8, 12, 16, 20, and 24Population: ITT population; n=number of participants assessed for the specified parameter at a given visit.
The HAQ-DI was used to assess the physical ability and functional status of participants as well as quality of life. The disability dimension consists of 20 multiple choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from 4 response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=32 Participants
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
|
|---|---|
|
Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
Week 0 (n=32)
|
1.77 scores on a scale
Standard Deviation 0.43
|
|
Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
Week 4 (n=32)
|
1.56 scores on a scale
Standard Deviation 0.49
|
|
Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
Week 8 (n=30)
|
1.31 scores on a scale
Standard Deviation 0.65
|
|
Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
Week 12 (n=30)
|
1.28 scores on a scale
Standard Deviation 0.65
|
|
Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
Week 16 (n=30)
|
1.23 scores on a scale
Standard Deviation 0.64
|
|
Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
Week 20 (n=30)
|
1.20 scores on a scale
Standard Deviation 0.644
|
|
Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
Week 24 (n=30)
|
1.16 scores on a scale
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: Weeks 0, 12, and 24Population: ITT population; n=number of participants assessed for the specified parameter at a given visit.
The SF-36 measures the impact of disease on overall quality of life and consists of 8 subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. Scores for each subscale range from 0 to 10, and the composite scores range from 0 to 100, with higher scores indicating better health.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=32 Participants
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
|
|---|---|
|
Short Form-36 (SF-36)
Energy/fatigue, Week 0 (n=32)
|
30.31 scores on a scale
Standard Deviation 17.93
|
|
Short Form-36 (SF-36)
Physical Functioning, Week 0 (n=32)
|
26.08 scores on a scale
Standard Deviation 18.09
|
|
Short Form-36 (SF-36)
Physical Functioning, Week 12 (n=30)
|
44.50 scores on a scale
Standard Deviation 27.58
|
|
Short Form-36 (SF-36)
Physical Functioning, Week 24 (n=30)
|
47.22 scores on a scale
Standard Deviation 31.92
|
|
Short Form-36 (SF-36)
Role limits due to physical health, Week 0 (n=32)
|
6.25 scores on a scale
Standard Deviation 18.71
|
|
Short Form-36 (SF-36)
Role limits due to physical health, Week 12 (n=30)
|
49.17 scores on a scale
Standard Deviation 45.34
|
|
Short Form-36 (SF-36)
Role limits due to physical health, Week 24 (n=30)
|
44.44 scores on a scale
Standard Deviation 45.60
|
|
Short Form-36 (SF-36)
Role limits due to emotional prob., Week 0 (n=32)
|
16.67 scores on a scale
Standard Deviation 34.23
|
|
Short Form-36 (SF-36)
Role limits due to emotional prob., Week 12 (n=30)
|
61.11 scores on a scale
Standard Deviation 45.34
|
|
Short Form-36 (SF-36)
Role limits due to emotional prob., Week 24 (n=30)
|
55.56 scores on a scale
Standard Deviation 48.47
|
|
Short Form-36 (SF-36)
Energy/ fatigue, Week 12 (n=30)
|
48.33 scores on a scale
Standard Deviation 26.14
|
|
Short Form-36 (SF-36)
Energy/fatigue, Week 24 (n=30)
|
50.00 scores on a scale
Standard Deviation 31.32
|
|
Short Form-36 (SF-36)
Emotional well-being, Week 0 (n=32)
|
50.00 scores on a scale
Standard Deviation 19.10
|
|
Short Form-36 (SF-36)
Emotional well-being, Week 12 (n=30)
|
63.70 scores on a scale
Standard Deviation 24.16
|
|
Short Form-36 (SF-36)
Emotional well-being, Week 24 (n=30)
|
65.33 scores on a scale
Standard Deviation 32.92
|
|
Short Form-36 (SF-36)
Social functioning, Week 0 (n=32)
|
39.45 scores on a scale
Standard Deviation 17.61
|
|
Short Form-36 (SF-36)
Social functioning, Week 12 (n=30)
|
60.83 scores on a scale
Standard Deviation 25.36
|
|
Short Form-36 (SF-36)
Social functioning, Week 24 (n=30)
|
62.50 scores on a scale
Standard Deviation 35.11
|
|
Short Form-36 (SF-36)
Pain, Week 0 (n=32)
|
28.67 scores on a scale
Standard Deviation 15.34
|
|
Short Form-36 (SF-36)
Pain, Week 12 (n=30)
|
55.75 scores on a scale
Standard Deviation 27.63
|
|
Short Form-36 (SF-36)
Pain, Week 24 (n=30)
|
56.11 scores on a scale
Standard Deviation 33.32
|
|
Short Form-36 (SF-36)
General health, Week 0 (n=32)
|
38.28 scores on a scale
Standard Deviation 10.82
|
|
Short Form-36 (SF-36)
General health, Week 12 (n=30)
|
46.83 scores on a scale
Standard Deviation 16.32
|
|
Short Form-36 (SF-36)
General health, Week 24 (n=30)
|
46.25 scores on a scale
Standard Deviation 23.41
|
Adverse Events
Tocilizumab 8 mg/kg
Serious adverse events
| Measure |
Tocilizumab 8 mg/kg
n=32 participants at risk
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
|
|---|---|
|
Infections and infestations
Crash of left foot local infection of skin and subcutaneous tissue
|
3.1%
1/32 • Serious adverse events (SAEs) related to study medication were reported irrespective of elapsed time from last administration of study medication. Non-related SAEs were reported during the study period and 28 days after the last dose of study medication.
|
|
Infections and infestations
Bronchopneumonia
|
3.1%
1/32 • Serious adverse events (SAEs) related to study medication were reported irrespective of elapsed time from last administration of study medication. Non-related SAEs were reported during the study period and 28 days after the last dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Lumbago
|
3.1%
1/32 • Serious adverse events (SAEs) related to study medication were reported irrespective of elapsed time from last administration of study medication. Non-related SAEs were reported during the study period and 28 days after the last dose of study medication.
|
|
Cardiac disorders
Congestive heart failure
|
3.1%
1/32 • Serious adverse events (SAEs) related to study medication were reported irrespective of elapsed time from last administration of study medication. Non-related SAEs were reported during the study period and 28 days after the last dose of study medication.
|
Other adverse events
| Measure |
Tocilizumab 8 mg/kg
n=32 participants at risk
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
|
|---|---|
|
Hepatobiliary disorders
Hepatopathy
|
6.2%
2/32 • Number of events 2 • Serious adverse events (SAEs) related to study medication were reported irrespective of elapsed time from last administration of study medication. Non-related SAEs were reported during the study period and 28 days after the last dose of study medication.
|
|
Blood and lymphatic system disorders
Leucopenia+lymphopenia
|
9.4%
3/32 • Number of events 3 • Serious adverse events (SAEs) related to study medication were reported irrespective of elapsed time from last administration of study medication. Non-related SAEs were reported during the study period and 28 days after the last dose of study medication.
|
|
Reproductive system and breast disorders
Acute bronchitis
|
9.4%
3/32 • Number of events 3 • Serious adverse events (SAEs) related to study medication were reported irrespective of elapsed time from last administration of study medication. Non-related SAEs were reported during the study period and 28 days after the last dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Acute nasopharyngitis
|
3.1%
1/32 • Number of events 1 • Serious adverse events (SAEs) related to study medication were reported irrespective of elapsed time from last administration of study medication. Non-related SAEs were reported during the study period and 28 days after the last dose of study medication.
|
|
Infections and infestations
Acute pulpitis
|
3.1%
1/32 • Number of events 2 • Serious adverse events (SAEs) related to study medication were reported irrespective of elapsed time from last administration of study medication. Non-related SAEs were reported during the study period and 28 days after the last dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER