Trial Outcomes & Findings for A Study in Patients With Moderate to Severe Active Rheumatoid Arthritis Comparing Different Infusion Durations of RoActemra/Actemra (Tocilizumab) Treatment (NCT NCT01468077)
NCT ID: NCT01468077
Last Updated: 2015-08-17
Results Overview
An infusion reaction was defined as any adverse event (AE) that occurred during the infusion or during the 24 hours following the infusion and deemed possibly or probably related to tocilizumab.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
Baseline (Day 1), and Weeks 4, 8, 12, 16, and 20
Results posted on
2015-08-17
Participant Flow
Participant milestones
| Measure |
Tocilizumab, Normal Administration
Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenously (IV) over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
|
Tocilizumab, Fast Administration
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
25
|
|
Overall Study
COMPLETED
|
18
|
22
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
Tocilizumab, Normal Administration
Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenously (IV) over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
|
Tocilizumab, Fast Administration
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
A Study in Patients With Moderate to Severe Active Rheumatoid Arthritis Comparing Different Infusion Durations of RoActemra/Actemra (Tocilizumab) Treatment
Baseline characteristics by cohort
| Measure |
Tocilizumab, Normal Administration
n=22 Participants
Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
|
Tocilizumab, Fast Administration
n=25 Participants
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.5 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
59.8 years
STANDARD_DEVIATION 13.1 • n=7 Participants
|
58.7 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1), and Weeks 4, 8, 12, 16, and 20Population: Safety Analysis Set (SAS) Population: All randomized participants who received at least one infusion of tocilizumab.
An infusion reaction was defined as any adverse event (AE) that occurred during the infusion or during the 24 hours following the infusion and deemed possibly or probably related to tocilizumab.
Outcome measures
| Measure |
Tocilizumab, Normal Administration
n=22 Participants
Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
|
Tocilizumab, Fast Administration
n=25 Participants
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
|
|---|---|---|
|
Percentage of Participants With Any Infusion Reaction
|
13.6 Percentage of Participants
|
12.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and Weeks 4, 8, 12, 16, 20, and 24Population: SAS Population
All occurrences of participants who received at least 1 infusion of tocilizumab and then stopped tocilizumab infusions due to an AE or SAE were analyzed.
Outcome measures
| Measure |
Tocilizumab, Normal Administration
n=22 Participants
Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
|
Tocilizumab, Fast Administration
n=25 Participants
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
|
|---|---|---|
|
Percentage of Participants Discontinuing Tocilizumab in Response to an AE or a Serious Adverse Event (SAE)
|
9.0 Percentage of Participants
|
8.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks, 4, 8, 12, 16, 20, and 24Population: SAS Population
Participants that stopped the administration of tocilizumab and discontinued the study prematurely due to reasons other than an AE or SAE were analyzed.
Outcome measures
| Measure |
Tocilizumab, Normal Administration
n=22 Participants
Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
|
Tocilizumab, Fast Administration
n=25 Participants
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
|
|---|---|---|
|
Percentage of Participants Discontinuing Tocilizumab for Other Reasons
|
9 Percentage of Participants
|
4 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 4, 8, 12, 16, 20, and 24Population: ITT Completers with liver enzyme datasets for each analyzed visit
Increased liver enzyme values defined as Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) values of \>1.5 times, or \>3 times, or \>5 times over the ULN. Almost none of the participants had increased measurements of AST, thus only values of ALT were presented. None of the participants presented with increased values of ALT above 3 or 5 ULN at any of the visits. ITT Completers is defined as a subset of the participants in the ITT population who completed all study visits.
Outcome measures
| Measure |
Tocilizumab, Normal Administration
n=17 Participants
Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
|
Tocilizumab, Fast Administration
n=21 Participants
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
|
|---|---|---|
|
Percentage of Participants With Increased Liver Enzyme Values of Greater Than (>)1.5 Times, or >3 Times, or >5 Times Over the Upper Limit of Normal (ULN) by Visit Among Participants Who Completed All Visits
ALT>1.5 ULN, Week 4
|
12 Percentage of Participants
|
5 Percentage of Participants
|
|
Percentage of Participants With Increased Liver Enzyme Values of Greater Than (>)1.5 Times, or >3 Times, or >5 Times Over the Upper Limit of Normal (ULN) by Visit Among Participants Who Completed All Visits
ALT>1.5 ULN, Week 8
|
6 Percentage of Participants
|
10 Percentage of Participants
|
|
Percentage of Participants With Increased Liver Enzyme Values of Greater Than (>)1.5 Times, or >3 Times, or >5 Times Over the Upper Limit of Normal (ULN) by Visit Among Participants Who Completed All Visits
ALT>1.5 ULN, Week 12
|
6 Percentage of Participants
|
5 Percentage of Participants
|
|
Percentage of Participants With Increased Liver Enzyme Values of Greater Than (>)1.5 Times, or >3 Times, or >5 Times Over the Upper Limit of Normal (ULN) by Visit Among Participants Who Completed All Visits
ALT>1.5 ULN, Week 16
|
6 Percentage of Participants
|
10 Percentage of Participants
|
|
Percentage of Participants With Increased Liver Enzyme Values of Greater Than (>)1.5 Times, or >3 Times, or >5 Times Over the Upper Limit of Normal (ULN) by Visit Among Participants Who Completed All Visits
ALT>1.5 ULN, Week 20
|
12 Percentage of Participants
|
5 Percentage of Participants
|
|
Percentage of Participants With Increased Liver Enzyme Values of Greater Than (>)1.5 Times, or >3 Times, or >5 Times Over the Upper Limit of Normal (ULN) by Visit Among Participants Who Completed All Visits
ALT>1.5 ULN, Week 24
|
24 Percentage of Participants
|
5 Percentage of Participants
|
SECONDARY outcome
Timeframe: Screening and Weeks 4, 8, 12, 16, 20, and 24Population: ITT Completers
Increased levels of high density lipoproteins (HDL) equal to or greater than (≥)1.5 millimoles per liter (mmol/L), and low density lipoproteins (LDL) ≥4.1 mmol/L, and total cholesterol ≥5.1 mmol/L, are defined according to the Adult Treatment Panel III (ATP-III) guidelines.
Outcome measures
| Measure |
Tocilizumab, Normal Administration
n=18 Participants
Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
|
Tocilizumab, Fast Administration
n=22 Participants
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
|
|---|---|---|
|
Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits
High HDL (≥1.5 mmol/L), Screening
|
44 Percentage of Participants
|
46 Percentage of Participants
|
|
Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits
High HDL (≥1.5 mmol/L), Week 4
|
44 Percentage of Participants
|
55 Percentage of Participants
|
|
Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits
High HDL (≥1.5 mmol/L), Week 8
|
50 Percentage of Participants
|
36 Percentage of Participants
|
|
Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits
High HDL (≥1.5 mmol/L), Week 12
|
39 Percentage of Participants
|
50 Percentage of Participants
|
|
Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits
High HDL (≥1.5 mmol/L), Week 16
|
44 Percentage of Participants
|
41 Percentage of Participants
|
|
Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits
High HDL (≥1.5 mmol/L), Week 20
|
39 Percentage of Participants
|
36 Percentage of Participants
|
|
Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits
High HDL (≥1.5 mmol/L), Week 24
|
44 Percentage of Participants
|
46 Percentage of Participants
|
|
Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits
High LDL (≥4.1 mmol/L), Screening
|
0 Percentage of Participants
|
14 Percentage of Participants
|
|
Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits
High LDL (≥4.1 mmol/L), Week 4
|
11 Percentage of Participants
|
27 Percentage of Participants
|
|
Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits
High LDL (≥4.1 mmol/L), Week 8
|
6 Percentage of Participants
|
32 Percentage of Participants
|
|
Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits
High LDL (≥4.1 mmol/L), Week 12
|
6 Percentage of Participants
|
36 Percentage of Participants
|
|
Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits
High LDL (≥4.1 mmol/L), Week 16
|
6 Percentage of Participants
|
23 Percentage of Participants
|
|
Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits
High LDL (≥4.1 mmol/L), Week 20
|
11 Percentage of Participants
|
32 Percentage of Participants
|
|
Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits
High LDL (≥4.1 mmol/L), Week 24
|
6 Percentage of Participants
|
18 Percentage of Participants
|
|
Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits
High total cholesterol (≥5.1 mmol/L), Screening
|
33 Percentage of Participants
|
59 Percentage of Participants
|
|
Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits
High total cholesterol (≥5.1 mmol/L), Week 4
|
56 Percentage of Participants
|
73 Percentage of Participants
|
|
Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits
High total cholesterol (≥5.1 mmol/L), Week 8
|
61 Percentage of Participants
|
73 Percentage of Participants
|
|
Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits
High total cholesterol (≥5.1 mmol/L), Week 12
|
56 Percentage of Participants
|
68 Percentage of Participants
|
|
Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits
High total cholesterol (≥5.1 mmol/L), Week 16
|
61 Percentage of Participants
|
64 Percentage of Participants
|
|
Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits
High total cholesterol (≥5.1 mmol/L), Week 20
|
61 Percentage of Participants
|
59 Percentage of Participants
|
|
Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits
High total cholesterol (≥5.1 mmol/L), Week 24
|
56 Percentage of Participants
|
64 Percentage of Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, and 24Population: ITT Completers
Improvement in Rheumatoid Arthritis (RA) disease activity was measured by the DAS28 score, which is an index combining measurements of swollen and tender joints, acute phase response High sensitivity C-Reactive Protein (hsCRP), and global assessment of disease activity by the participant. A clinically meaningful improvement was defined as a reduction of at least 1.2 units in the DAS28 score during the study period. A low disease activity was defined as a DAS28 score less than (\<)3.2, and remission was defined as a DAS28 score \<2.6.
Outcome measures
| Measure |
Tocilizumab, Normal Administration
n=18 Participants
Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
|
Tocilizumab, Fast Administration
n=22 Participants
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
|
|---|---|---|
|
Percentage of Participants With a Reduction of at Least 1.2 Points in Disease Activity Score Based on 28-Joint Count (DAS28) by Visit Among Participants Who Completed All Visits
Week 4
|
67 Percentage of Participants
|
55 Percentage of Participants
|
|
Percentage of Participants With a Reduction of at Least 1.2 Points in Disease Activity Score Based on 28-Joint Count (DAS28) by Visit Among Participants Who Completed All Visits
Week 8
|
89 Percentage of Participants
|
73 Percentage of Participants
|
|
Percentage of Participants With a Reduction of at Least 1.2 Points in Disease Activity Score Based on 28-Joint Count (DAS28) by Visit Among Participants Who Completed All Visits
Week 12
|
89 Percentage of Participants
|
82 Percentage of Participants
|
|
Percentage of Participants With a Reduction of at Least 1.2 Points in Disease Activity Score Based on 28-Joint Count (DAS28) by Visit Among Participants Who Completed All Visits
Week 16
|
94 Percentage of Participants
|
77 Percentage of Participants
|
|
Percentage of Participants With a Reduction of at Least 1.2 Points in Disease Activity Score Based on 28-Joint Count (DAS28) by Visit Among Participants Who Completed All Visits
Week 20
|
94 Percentage of Participants
|
82 Percentage of Participants
|
|
Percentage of Participants With a Reduction of at Least 1.2 Points in Disease Activity Score Based on 28-Joint Count (DAS28) by Visit Among Participants Who Completed All Visits
Week 24
|
89 Percentage of Participants
|
86 Percentage of Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, and 24Population: ITT Completers
Improvement in RA disease activity was measured by the DAS28 score, which is an index combining measurements of swollen and tender joints, acute phase response hsCRP, and global assessment of disease activity by the participant. A clinically meaningful improvement was defined as a reduction of at least 1.2 units in the DAS28 score during the study period. A low disease activity was defined as a DAS28 score \<3.2, and remission was defined as a DAS28 score \<2.6.
Outcome measures
| Measure |
Tocilizumab, Normal Administration
n=18 Participants
Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
|
Tocilizumab, Fast Administration
n=22 Participants
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
|
|---|---|---|
|
Percentage of Participants Achieving a DAS28 Score Below 3.2 (Low Disease Activity) by Visit Among Participants Who Completed All Visits
Week 4
|
44 Percentage of Participants
|
27 Percentage of Participants
|
|
Percentage of Participants Achieving a DAS28 Score Below 3.2 (Low Disease Activity) by Visit Among Participants Who Completed All Visits
Week 8
|
67 Percentage of Participants
|
55 Percentage of Participants
|
|
Percentage of Participants Achieving a DAS28 Score Below 3.2 (Low Disease Activity) by Visit Among Participants Who Completed All Visits
Week 12
|
78 Percentage of Participants
|
82 Percentage of Participants
|
|
Percentage of Participants Achieving a DAS28 Score Below 3.2 (Low Disease Activity) by Visit Among Participants Who Completed All Visits
Week 16
|
94 Percentage of Participants
|
68 Percentage of Participants
|
|
Percentage of Participants Achieving a DAS28 Score Below 3.2 (Low Disease Activity) by Visit Among Participants Who Completed All Visits
Week 20
|
89 Percentage of Participants
|
73 Percentage of Participants
|
|
Percentage of Participants Achieving a DAS28 Score Below 3.2 (Low Disease Activity) by Visit Among Participants Who Completed All Visits
Week 24
|
83 Percentage of Participants
|
77 Percentage of Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, and 24Population: ITT Completers
Improvement in RA disease activity was measured by the DAS28 score, which is an index combining measurements of swollen and tender joints, acute phase response hsCRP, and global assessment of disease activity by the participant. A clinically meaningful improvement was defined as a reduction of at least 1.2 units in the DAS28 score during the study period. A low disease activity was defined as a DAS28 score \<3.2, and remission was defined as a DAS28 score \<2.6.
Outcome measures
| Measure |
Tocilizumab, Normal Administration
n=18 Participants
Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
|
Tocilizumab, Fast Administration
n=22 Participants
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
|
|---|---|---|
|
Percentage of Participants Achieving a DAS28 Score Below 2.6 (Remission) by Visit Among Participants Who Completed All Visits
Week 4
|
22 Percentage of Participants
|
9 Percentage of Participants
|
|
Percentage of Participants Achieving a DAS28 Score Below 2.6 (Remission) by Visit Among Participants Who Completed All Visits
Week 8
|
28 Percentage of Participants
|
36 Percentage of Participants
|
|
Percentage of Participants Achieving a DAS28 Score Below 2.6 (Remission) by Visit Among Participants Who Completed All Visits
Week 12
|
50 Percentage of Participants
|
73 Percentage of Participants
|
|
Percentage of Participants Achieving a DAS28 Score Below 2.6 (Remission) by Visit Among Participants Who Completed All Visits
Week 16
|
78 Percentage of Participants
|
46 Percentage of Participants
|
|
Percentage of Participants Achieving a DAS28 Score Below 2.6 (Remission) by Visit Among Participants Who Completed All Visits
Week 20
|
72 Percentage of Participants
|
59 Percentage of Participants
|
|
Percentage of Participants Achieving a DAS28 Score Below 2.6 (Remission) by Visit Among Participants Who Completed All Visits
Week 24
|
61 Percentage of Participants
|
55 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks, 4, 8, 12, 16, 20, and 24Population: ITT Completers; n = the number of participants analyzed for the given parameter at the specific visit.
Improvement in RA disease activity was measured by the DAS28 score, which is an index combining measurements of swollen and tender joints, acute phase response hsCRP, and global assessment of disease activity by the participant. A clinically meaningful improvement was defined as a reduction of at least 1.2 units in the DAS28 score during the study period. A low disease activity was defined as a DAS28 score \<3.2, and remission was defined as a DAS28 score \<2.6.
Outcome measures
| Measure |
Tocilizumab, Normal Administration
n=18 Participants
Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
|
Tocilizumab, Fast Administration
n=22 Participants
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
|
|---|---|---|
|
DAS28 Score by Visit Among Participants Who Completed All Visits
Baseline (n=18,21)
|
5.0 scores on a scale
Standard Deviation 1.1
|
5.0 scores on a scale
Standard Deviation 0.9
|
|
DAS28 Score by Visit Among Participants Who Completed All Visits
Week 4 (n=18,21)
|
3.3 scores on a scale
Standard Deviation 0.8
|
3.6 scores on a scale
Standard Deviation 1.0
|
|
DAS28 Score by Visit Among Participants Who Completed All Visits
Week 8 (n=18,22)
|
2.9 scores on a scale
Standard Deviation 0.8
|
3.1 scores on a scale
Standard Deviation 1.2
|
|
DAS28 Score by Visit Among Participants Who Completed All Visits
Week 12 (n=18,22)
|
2.6 scores on a scale
Standard Deviation 0.9
|
2.4 scores on a scale
Standard Deviation 1.0
|
|
DAS28 Score by Visit Among Participants Who Completed All Visits
Week 16 (n=18,21)
|
2.3 scores on a scale
Standard Deviation 0.4
|
2.6 scores on a scale
Standard Deviation 1.0
|
|
DAS28 Score by Visit Among Participants Who Completed All Visits
Week 20 (n=18,22)
|
2.3 scores on a scale
Standard Deviation 0.6
|
2.6 scores on a scale
Standard Deviation 0.9
|
|
DAS28 Score by Visit Among Participants Who Completed All Visits
Week 24 (n=18,22)
|
2.3 scores on a scale
Standard Deviation 0.6
|
2.5 scores on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, and 24Population: ITT Completers
ACR20 response is defined as an improvement of ≥20% in swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) as well as ≥20% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; Health Assessment Questionnaire - Disability Index (HAQ-DI); and acute phase reactive factors (Erythrocyte Sedimentation Rate \[ESR\] or C-Reactive Protein \[CRP\]).
Outcome measures
| Measure |
Tocilizumab, Normal Administration
n=18 Participants
Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
|
Tocilizumab, Fast Administration
n=22 Participants
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
|
|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) by Visit Among Participants Who Completed All Visits
Week 4
|
50 Percentage of Participants
|
41 Percentage of Participants
|
|
Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) by Visit Among Participants Who Completed All Visits
Week 8
|
67 Percentage of Participants
|
59 Percentage of Participants
|
|
Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) by Visit Among Participants Who Completed All Visits
Week 12
|
72 Percentage of Participants
|
68 Percentage of Participants
|
|
Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) by Visit Among Participants Who Completed All Visits
Week 16
|
83 Percentage of Participants
|
77 Percentage of Participants
|
|
Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) by Visit Among Participants Who Completed All Visits
Week 20
|
83 Percentage of Participants
|
73 Percentage of Participants
|
|
Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) by Visit Among Participants Who Completed All Visits
Week 24
|
89 Percentage of Participants
|
91 Percentage of Participants
|
SECONDARY outcome
Timeframe: Weeks, 4, 8, 12, 16, 20, and 24Population: ITT Completers
ACR50 response is defined as an improvement of ≥50% in SJC (66 joints) and TJC (68 joints) as well as ≥50% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP).
Outcome measures
| Measure |
Tocilizumab, Normal Administration
n=18 Participants
Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
|
Tocilizumab, Fast Administration
n=22 Participants
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
|
|---|---|---|
|
Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) by Visit Among Participants Who Completed All Visits
Week 4
|
28 Percentage of Participants
|
18 Percentage of Participants
|
|
Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) by Visit Among Participants Who Completed All Visits
Week 8
|
28 Percentage of Participants
|
36 Percentage of Participants
|
|
Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) by Visit Among Participants Who Completed All Visits
Week 12
|
50 Percentage of Participants
|
50 Percentage of Participants
|
|
Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) by Visit Among Participants Who Completed All Visits
Week 16
|
44 Percentage of Participants
|
46 Percentage of Participants
|
|
Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) by Visit Among Participants Who Completed All Visits
Week 20
|
67 Percentage of Participants
|
55 Percentage of Participants
|
|
Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) by Visit Among Participants Who Completed All Visits
Week 24
|
72 Percentage of Participants
|
73 Percentage of Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20 and 24Population: ITT Completers
ACR70 response is defined as an improvement of ≥70% in SJC (66 joints) and TJC (68 joints) as well as ≥70% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP).
Outcome measures
| Measure |
Tocilizumab, Normal Administration
n=18 Participants
Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
|
Tocilizumab, Fast Administration
n=22 Participants
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
|
|---|---|---|
|
Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) by Visit, Among Participants Who Completed All Visits
Week 4
|
11 Percentage of Participants
|
5 Percentage of Participants
|
|
Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) by Visit, Among Participants Who Completed All Visits
Week 8
|
17 Percentage of Participants
|
23 Percentage of Participants
|
|
Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) by Visit, Among Participants Who Completed All Visits
Week 12
|
22 Percentage of Participants
|
36 Percentage of Participants
|
|
Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) by Visit, Among Participants Who Completed All Visits
Week 16
|
11 Percentage of Participants
|
27 Percentage of Participants
|
|
Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) by Visit, Among Participants Who Completed All Visits
Week 20
|
22 Percentage of Participants
|
18 Percentage of Participants
|
|
Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) by Visit, Among Participants Who Completed All Visits
Week 24
|
22 Percentage of Participants
|
36 Percentage of Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20 and 24Population: ITT Completers
ACR90 response is defined as an improvement of ≥90% in SJC (66 joints) and TJC (68 joints) as well as ≥90% improvement in at least 3 of the following 5 remaining ACR assessments: Patient Global Assessment of Pain; Patient Global Assessment of Disease Activity; Physician Global Assessment of Disease Activity; HAQ-DI; and acute phase reactive factors (ESR or CRP).
Outcome measures
| Measure |
Tocilizumab, Normal Administration
n=18 Participants
Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
|
Tocilizumab, Fast Administration
n=22 Participants
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
|
|---|---|---|
|
Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) by Visit Among Participants Who Completed All Visits
Week 4
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) by Visit Among Participants Who Completed All Visits
Week 8
|
0 Percentage of Participants
|
9 Percentage of Participants
|
|
Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) by Visit Among Participants Who Completed All Visits
Week 12
|
0 Percentage of Participants
|
14 Percentage of Participants
|
|
Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) by Visit Among Participants Who Completed All Visits
Week 16
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) by Visit Among Participants Who Completed All Visits
Week 20
|
6 Percentage of Participants
|
5 Percentage of Participants
|
|
Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) by Visit Among Participants Who Completed All Visits
Week 24
|
6 Percentage of Participants
|
9 Percentage of Participants
|
SECONDARY outcome
Timeframe: Screening, Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: ITT Completers
hsCRP is a marker for inflammation and is measured in milligrams per liter (mg/L). High levels of this protein indicate inflammation in diseases such as RA.
Outcome measures
| Measure |
Tocilizumab, Normal Administration
n=18 Participants
Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
|
Tocilizumab, Fast Administration
n=22 Participants
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
|
|---|---|---|
|
High Sensitivity C-Reactive Protein (hsCRP) Levels by Visit Among Participants Who Completed All Visits
Screening
|
22.8 mg/L
Standard Deviation 19.8
|
25.9 mg/L
Standard Deviation 36.0
|
|
High Sensitivity C-Reactive Protein (hsCRP) Levels by Visit Among Participants Who Completed All Visits
Baseline
|
23.5 mg/L
Standard Deviation 22.7
|
27.0 mg/L
Standard Deviation 32.1
|
|
High Sensitivity C-Reactive Protein (hsCRP) Levels by Visit Among Participants Who Completed All Visits
Week 4
|
4.7 mg/L
Standard Deviation 6.6
|
3.1 mg/L
Standard Deviation 3.4
|
|
High Sensitivity C-Reactive Protein (hsCRP) Levels by Visit Among Participants Who Completed All Visits
Week 8
|
3.3 mg/L
Standard Deviation 3.3
|
4.5 mg/L
Standard Deviation 3.8
|
|
High Sensitivity C-Reactive Protein (hsCRP) Levels by Visit Among Participants Who Completed All Visits
Week 12
|
3.2 mg/L
Standard Deviation 3.4
|
2.6 mg/L
Standard Deviation 3.3
|
|
High Sensitivity C-Reactive Protein (hsCRP) Levels by Visit Among Participants Who Completed All Visits
Week 16
|
2.8 mg/L
Standard Deviation 3.1
|
3.1 mg/L
Standard Deviation 3.3
|
|
High Sensitivity C-Reactive Protein (hsCRP) Levels by Visit Among Participants Who Completed All Visits
Week 20
|
2.9 mg/L
Standard Deviation 3.0
|
3.0 mg/L
Standard Deviation 3.2
|
|
High Sensitivity C-Reactive Protein (hsCRP) Levels by Visit Among Participants Who Completed All Visits
Week 24
|
3.2 mg/L
Standard Deviation 3.5
|
3.4 mg/L
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 20, and 24Population: ITT Completers
M-HAQ is a self-reported, valid assessment of functional disability in RA. Assessment based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. Scores range 0 to 3; without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3.
Outcome measures
| Measure |
Tocilizumab, Normal Administration
n=18 Participants
Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
|
Tocilizumab, Fast Administration
n=22 Participants
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
|
|---|---|---|
|
Modified Health Assessment Questionnaire (M-HAQ) Score by Visit Among Participants Who Completed All Visits
Baseline
|
1.29 scores on a scale
Standard Deviation 0.71
|
1.50 scores on a scale
Standard Deviation 0.74
|
|
Modified Health Assessment Questionnaire (M-HAQ) Score by Visit Among Participants Who Completed All Visits
Week 4
|
0.97 scores on a scale
Standard Deviation 0.64
|
1.10 scores on a scale
Standard Deviation 0.64
|
|
Modified Health Assessment Questionnaire (M-HAQ) Score by Visit Among Participants Who Completed All Visits
Week 8
|
0.79 scores on a scale
Standard Deviation 0.67
|
0.95 scores on a scale
Standard Deviation 0.68
|
|
Modified Health Assessment Questionnaire (M-HAQ) Score by Visit Among Participants Who Completed All Visits
Week 12
|
0.80 scores on a scale
Standard Deviation 0.70
|
0.98 scores on a scale
Standard Deviation 0.62
|
|
Modified Health Assessment Questionnaire (M-HAQ) Score by Visit Among Participants Who Completed All Visits
Week 16
|
0.82 scores on a scale
Standard Deviation 0.69
|
0.94 scores on a scale
Standard Deviation 0.69
|
|
Modified Health Assessment Questionnaire (M-HAQ) Score by Visit Among Participants Who Completed All Visits
Week 20
|
0.75 scores on a scale
Standard Deviation 0.61
|
1.05 scores on a scale
Standard Deviation 0.77
|
|
Modified Health Assessment Questionnaire (M-HAQ) Score by Visit Among Participants Who Completed All Visits
Week 24
|
0.68 scores on a scale
Standard Deviation 0.63
|
1.07 scores on a scale
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: Weeks 4, 8. 12, 20, and 24Population: ITT Completers
M-HAQ is a self-reported, valid assessment of functional disability in RA. Assessment based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. Scores range 0 to 3; without any difficulty=0, with some difficulty=1, with much difficulty=2, unable to do=3.
Outcome measures
| Measure |
Tocilizumab, Normal Administration
n=18 Participants
Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
|
Tocilizumab, Fast Administration
n=22 Participants
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
|
|---|---|---|
|
Percentage of Participants With Improvement of at Least 0.22 Units in M-HAQ Compared to Baseline Per Visit Among Participants Who Completed All Visits
Week 4
|
44.4 Percentage of Participants
|
45.5 Percentage of Participants
|
|
Percentage of Participants With Improvement of at Least 0.22 Units in M-HAQ Compared to Baseline Per Visit Among Participants Who Completed All Visits
Week 8
|
72.2 Percentage of Participants
|
59.1 Percentage of Participants
|
|
Percentage of Participants With Improvement of at Least 0.22 Units in M-HAQ Compared to Baseline Per Visit Among Participants Who Completed All Visits
Week 12
|
72.2 Percentage of Participants
|
54.5 Percentage of Participants
|
|
Percentage of Participants With Improvement of at Least 0.22 Units in M-HAQ Compared to Baseline Per Visit Among Participants Who Completed All Visits
Week 16
|
77.8 Percentage of Participants
|
63.6 Percentage of Participants
|
|
Percentage of Participants With Improvement of at Least 0.22 Units in M-HAQ Compared to Baseline Per Visit Among Participants Who Completed All Visits
Week 20
|
66.7 Percentage of Participants
|
59.1 Percentage of Participants
|
|
Percentage of Participants With Improvement of at Least 0.22 Units in M-HAQ Compared to Baseline Per Visit Among Participants Who Completed All Visits
Week 24
|
72.2 Percentage of Participants
|
50.0 Percentage of Participants
|
Adverse Events
Tocilizumab, Normal Administration
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Tocilizumab, Fast Administration
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tocilizumab, Normal Administration
n=22 participants at risk
Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
|
Tocilizumab, Fast Administration
n=25 participants at risk
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
|
|---|---|---|
|
Infections and infestations
Infective tenosynovitis
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
0.00%
0/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma cutis
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
0.00%
0/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
Other adverse events
| Measure |
Tocilizumab, Normal Administration
n=22 participants at risk
Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
|
Tocilizumab, Fast Administration
n=25 participants at risk
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
2/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
4.0%
1/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
16.0%
4/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Nervous system disorders
Headache
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
12.0%
3/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
2/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
0.00%
0/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
8.0%
2/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Infections and infestations
Nasopharyngitis
|
13.6%
3/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
20.0%
5/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Infections and infestations
Rhinitis
|
13.6%
3/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
0.00%
0/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
8.0%
2/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
12.0%
3/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Gastrointestinal disorders
Diarrhoea
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
8.0%
2/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
8.0%
2/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
General disorders
Fatigue
|
9.1%
2/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
12.0%
3/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
General disorders
Pain
|
0.00%
0/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
8.0%
2/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
9.1%
2/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
12.0%
3/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Infections and infestations
Skin infection
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
4.0%
1/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Infections and infestations
Wound infection
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
4.0%
1/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
4.0%
1/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
0.00%
0/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
0.00%
0/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Nervous system disorders
Migraine
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
0.00%
0/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
0.00%
0/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
4.0%
1/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
4.0%
1/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Skin and subcutaneous tissue disorders
Contusion
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
0.00%
0/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
0.00%
0/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
0.00%
0/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Eye disorders
Eye allergy
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
0.00%
0/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Eye disorders
Dry eye
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
0.00%
0/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Immune system disorders
Seasonal allergy
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
0.00%
0/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Investigations
Alanine aminotransferase increased
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
4.0%
1/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Infections and infestations
Abscess
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
0.00%
0/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Infections and infestations
Abscess limb
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
0.00%
0/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Infections and infestations
Herpes zoster
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
0.00%
0/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Infections and infestations
Infective tenosynovitis
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
0.00%
0/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Infections and infestations
Oral herpes
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
0.00%
0/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Infections and infestations
Otitis media
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
0.00%
0/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Infections and infestations
Pharyngitis
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
0.00%
0/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Infections and infestations
Vaginal infection
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
0.00%
0/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Infections and infestations
Vulvovaginal candidiasis
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
0.00%
0/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Gastrointestinal disorders
Dry mouth
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
0.00%
0/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Gastrointestinal disorders
Haemorrhoids
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
0.00%
0/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
General disorders
Chest pain
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
0.00%
0/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
General disorders
Feeling cold
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
0.00%
0/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
General disorders
Oedema peripheral
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
0.00%
0/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Blood and lymphatic system disorders
Anaemia
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
0.00%
0/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
0.00%
0/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
0.00%
0/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Vascular disorders
Flushing
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
0.00%
0/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Vascular disorders
Hypertension
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
0.00%
0/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Psychiatric disorders
Insomnia
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
0.00%
0/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
|
Reproductive system and breast disorders
Menorrhagia
|
4.5%
1/22 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
0.00%
0/25 • Screening through Week 24 (or early withdrawal). For early withdrawal two follow-up visits occurred; at 4 weeks and at 12 weeks after the last infusion. A telephone call was sufficient for the last visit if laboratory procedures were not needed.
SAS Population
|
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 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.
- Publication restrictions are in place
Restriction type: OTHER