Trial Outcomes & Findings for A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs (REMISSION) (NCT NCT01610791)
NCT ID: NCT01610791
Last Updated: 2014-07-10
Results Overview
Percentage of participants with adverse events (AEs), serious adverse events (SAEs), severe AEs, AEs leading to withdrawal, AEs leading to death, and treatment-related AEs.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
121 participants
Primary outcome timeframe
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Results posted on
2014-07-10
Participant Flow
Participant milestones
| Measure |
Tocilizumab 8 mg/kg
Participants received tocilizumab 8 milligrams per kilogram (mg/kg), intravenously (IV), once every 4 weeks for a total of 6 infusions.
|
|---|---|
|
Overall Study
STARTED
|
121
|
|
Overall Study
COMPLETED
|
100
|
|
Overall Study
NOT COMPLETED
|
21
|
Reasons for withdrawal
| Measure |
Tocilizumab 8 mg/kg
Participants received tocilizumab 8 milligrams per kilogram (mg/kg), intravenously (IV), once every 4 weeks for a total of 6 infusions.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Adverse event and Investigator decision
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
Not determined
|
5
|
Baseline Characteristics
A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs (REMISSION)
Baseline characteristics by cohort
| Measure |
Tocilizumab 8 mg/kg
n=117 Participants
Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
|
|---|---|
|
Age, Continuous
|
46.3 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
96 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: Safety population: all participants who received at least one dose of study medication where at least one post-baseline assessment of safety was available.
Percentage of participants with adverse events (AEs), serious adverse events (SAEs), severe AEs, AEs leading to withdrawal, AEs leading to death, and treatment-related AEs.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=121 Participants
Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
|
|---|---|
|
Percentage of Participants With Adverse Events
AEs
|
48.8 percentage of participants
|
|
Percentage of Participants With Adverse Events
SAEs
|
10.7 percentage of participants
|
|
Percentage of Participants With Adverse Events
With severe AEs
|
8.3 percentage of participants
|
|
Percentage of Participants With Adverse Events
AEs leading to withdrawals
|
5.8 percentage of participants
|
|
Percentage of Participants With Adverse Events
AEs leading to death
|
0.8 percentage of participants
|
|
Percentage of Participants With Adverse Events
Treatment-related AEs
|
10.7 percentage of participants
|
|
Percentage of Participants With Adverse Events
Treatment-related SAEs
|
4.1 percentage of participants
|
|
Percentage of Participants With Adverse Events
Treatment-related severe AEs
|
5.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, and 24Population: All enrolled participants were included in the analysis
Percentage of participants discontinuing study treatment for any reason at every visit; causes of discontinuation in the summary included AEs, deaths, lost to follo-wup, AE and investigator decision and 'not determined'.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=121 Participants
Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
|
|---|---|
|
Percentage of Participants With All-Cause Discontinuation of Tocilizumab by Study Visit
Week 4
|
3.3 percentage of participants
|
|
Percentage of Participants With All-Cause Discontinuation of Tocilizumab by Study Visit
Week 8
|
3.3 percentage of participants
|
|
Percentage of Participants With All-Cause Discontinuation of Tocilizumab by Study Visit
Week 12
|
2.5 percentage of participants
|
|
Percentage of Participants With All-Cause Discontinuation of Tocilizumab by Study Visit
Week 16
|
2.5 percentage of participants
|
|
Percentage of Participants With All-Cause Discontinuation of Tocilizumab by Study Visit
Week 20
|
2.5 percentage of participants
|
|
Percentage of Participants With All-Cause Discontinuation of Tocilizumab by Study Visit
Week 24
|
3.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline through Week 24Population: Safety Population
The difference between baseline and highest values until Week 24 of ALT and AST. The values are measures as international units per liter (UI/L). The change was calculated as the value (highest) at a later timepoint up to Week 24, minus the value at Baseline.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=121 Participants
Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
|
|---|---|
|
Change From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) to Highest Value
ALT
|
23.6 UI/L
Standard Deviation 34.7
|
|
Change From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) to Highest Value
AST
|
15.8 UI/L
Standard Deviation 22.1
|
SECONDARY outcome
Timeframe: Baseline through Week 24Population: Safety population
Levels of LDL and TC were measured in milligrams/deciliter (mg/dL). Change in LDL and TC were calculated as the value (highest) through Week 24, minus the value at Baseline.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=120 Participants
Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
|
|---|---|
|
Change From Baseline Low-Density Lipoprotein (LDL) and Total Cholesterol (TC) to Highest Values
Total cholesterol
|
57.2 mg/dL
Standard Deviation 78.1
|
|
Change From Baseline Low-Density Lipoprotein (LDL) and Total Cholesterol (TC) to Highest Values
LDL cholesterol
|
108.6 mg/dL
Standard Deviation 106.2
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: Safety population; n (number) = number of participants assessed for the parameter at a given visit.
Lipid panel assessed included TC, triglycerides, high-density lipoprotein (HDL), and LDL. Elevations were categorized as follows: LDL cholesterol: Optimal equals (=) less than (\<)100 mg/dL, Near optimal=100-129 mg/dL, Borderline high 130-159 mg/dL, High 160-189 mg/dL, Very High ≥190 mg/dL; Total cholesterol: Desirable \<200 mg/dL, Borderline high 200-239 mg/dL, High ≥240 mg/dL; HDL cholesterol: Low \<40 mg/dL, High ≥60 mg/dL; Triglycerides: Normal \<150 mg/dL, Borderline high 150-199 mg/dL, High 200-499 mg/dL, and Very high ≥500 mg/dL.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=121 Participants
Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
|
|---|---|
|
Percentage of Participants With Lipid Elevations by Study Visit
LDL Cholesterol: High, Week 4 (n=116)
|
7.8 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
LDL Cholesterol: High, Week 24 (n=98)
|
9.2 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
TC: High, Week 12 (n=109)
|
20.2 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
Triglycerides: Borderline High, Week 12 (n=109)
|
8.3 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
Triglycerides: Borderline High, Week 16 (n=106)
|
8.5 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
Triglycerides: Very High, Week 12 (n=109)
|
0.0 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
LDL Cholesterol: Optimal, Baseline (n=120)
|
53.3 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
LDL Cholesterol: Optimal, Week 4 (n=116)
|
32.8 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
LDL Cholesterol: Optimal, Week 8 (n=112)
|
42.9 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
LDL Cholesterol: Optimal, Week 12 (n=109)
|
33.9 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
LDL Cholesterol: Optimal, Week 16 (n=106)
|
18.9 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
LDL Cholesterol: Optimal, Week 20 (n=102)
|
38.2 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
LDL Cholesterol: Optimal, Week 24 (n=98)
|
28.6 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
LDL Cholesterol: Near Optimal, Baseline (n=120)
|
30.8 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
LDL Cholesterol: Near Optimal, Week 4 (n=116)
|
31.9 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
LDL Cholesterol: Near Optimal, Week 8 (n=112)
|
22.3 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
LDL Cholesterol: Near Optimal, Week 12 (n=109)
|
25.7 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
LDL Cholesterol: Near Optimal, Week 16 (n=106)
|
17.9 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
LDL Cholesterol: Near Optimal, Week 20 (n=102)
|
22.5 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
LDL Cholesterol: Near Optimal, Week 24 (n=98)
|
27.6 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
LDL Cholesterol: Borderline High, Baseline (n=120)
|
12.5 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
LDL Cholesterol: Borderline High, Week 4 (n=116)
|
21.6 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
LDL Cholesterol: Borderline High Week 8 (n=112)
|
23.2 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
LDL Cholesterol: Borderline High, Week 12 (n=109)
|
20.2 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
LDL Cholesterol: Borderline High, Week 16 (n=106)
|
15.1 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
LDL Cholesterol: Brderline High, Week 20 (n=102)
|
25.5 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
LDL Cholesterol: Borderline High, Week 24 (n=98)
|
29.6 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
LDL Cholesterol: High, Baseline (n=120)
|
2.5 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
LDL Cholesterol: High, Week 8 (n=112)
|
9.8 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
LDL Cholesterol: High, Week 12 (n=109)
|
14.7 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
LDL Cholesterol: High, Week 16 (n=106)
|
9.4 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
LDL Cholesterol: High, Week 20 (n=102)
|
10.8 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
LDL Cholesterol: Very High, Baseline (n=120)
|
0.8 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
LDL Cholesterol: Very High, Week 4 (n=116)
|
6.0 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
LDL Cholesterol: Very High, Week 8 (n=112)
|
1.8 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
LDL Cholesterol: Very High, Week 12 (n=109)
|
5.5 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
LDL Cholesterol: Very High, Week 16 (n=106)
|
38.7 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
LDL Cholesterol: Very High, Week 20 (n=102)
|
2.9 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
LDL Cholesterol: Very High, Week 24 (n=98)
|
5.1 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
TC: Desirable, Baseline (n=120)
|
77.5 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
TC: Desirable, Week 4 (n=116)
|
58.6 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
TC: Desirable, Week 8 (n=85)
|
28.6 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
TC: Desirable, Week 12 (n=109)
|
56.0 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
TC: Desirable, Week 16 (n=106)
|
56.6 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
TC: Desirable, Week 20 (n=103)
|
52.4 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
TC: Desirable, Week 24 (n=98)
|
51.0 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
TC: Borderline High, Baseline (n=120)
|
18.3 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
TC: Borderline High, Week 4 (n=116)
|
25.0 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
TC: Borderline High, Week 8 (n=85)
|
28.6 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
TC: Borderline High, Week 12 (n=109)
|
23.9 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
TC: Borderline High, Week 16 (n=106)
|
26.4 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
TC: Borderline High, Week 20 (n=103)
|
28.2 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
TC: Borderline High, Week 24 (n=98)
|
26.5 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
TC: High, Baseline (n=120)
|
4.2 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
TC: High, Week 4 (n=116)
|
16.4 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
TC: High, Week 8 (n=85)
|
18.8 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
TC: High, Week 16 (n=106)
|
17.0 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
TC: High, Week 20 (n=103)
|
19.4 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
TC: High, Week 24 (n=98)
|
22.4 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
HDL Cholesterol: Low, Baseline (n=49)
|
28.1 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
HDL Cholesterol: Low, Week 4 (n=47)
|
12.9 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
HDL Cholesterol: Low, Week 8 (n=54)
|
17.7 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
HDL Cholesterol: Low, Week 12 (n=42)
|
11.0 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
HDL Cholesterol: Low, Week 16 (n=51)
|
24.5 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
HDL Cholesterol: Low, Week 20 (n=52)
|
22.3 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
HDL Cholesterol: Low, Week 24 (n=48)
|
19.4 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
HDL Cholesterol: High, Baseline (n=49)
|
12.4 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
HDL Cholesterol: High, Week 4 (n=47)
|
27.6 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
HDL Cholesterol: High, Week 8 (n=54)
|
30.1 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
HDL Cholesterol: High, Week 12 (n=42)
|
27.5 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
HDL Cholesterol: High, Week 16 (n=51)
|
23.6 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
HDL Cholesterol: High, Week 20 (n=52)
|
28.2 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
HDL Cholesterol: High, Week 24 (n=48)
|
29.6 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
Triglycerides: Normal, Baseline (n=121)
|
88.4 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
Triglycerides: Normal, Week 4 (n=116)
|
40.5 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
Triglycerides: Normal, Week 8 (n=112)
|
82.1 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
Triglycerides: Normal, Week 12 (n=109)
|
80.7 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
Triglycerides: Normal, Week 16 (n=106)
|
82.1 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
Triglycerides: Normal, Week 20 (n=103)
|
75.7 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
Triglycerides: Normal, Week 24 (n=98)
|
72.4 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
Triglycerides: Borderline High, Baseline (n=121)
|
8.3 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
Triglycerides: Borderline High, Week 4 (n=116)
|
28.4 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
Triglycerides: Borderline High, Week 8 (n=112)
|
8.0 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
Triglycerides: Borderline High, Week 20 (n=103)
|
9.7 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
Triglycerides: Borderline High, Week 24 (n=98)
|
16.3 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
Triglycerides: High, Baseline (n=121)
|
3.3 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
Triglycerides: High, Week 4 (n=116)
|
25.9 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
Triglycerides: High, Week 8 (n=112)
|
9.8 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
Triglycerides: High, Week 12 (n=109)
|
11 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
Triglycerides: High, Week 16 (n=106)
|
8.5 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
Triglycerides: High, Week 20 (n=103)
|
14.6 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
Triglycerides: High, Week 24 (n=98)
|
11.2 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
Triglycerides: Very High, Baseline (n=121)
|
0.0 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
Triglycerides: Very High, Week 4 (n=116)
|
5.2 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
Triglycerides: Very High, Week 8 (n=112)
|
0.0 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
Triglycerides: Very High, Week 16 (n=106)
|
0.9 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
Triglycerides: Very High, Week 20 (n=103)
|
0.0 percentage of participants
|
|
Percentage of Participants With Lipid Elevations by Study Visit
Triglycerides: Very High, Week 24 (n=98)
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit.
DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR; in millimeters per hour \[mm/hour\]) and global health assessment (participant-rated global assessment of disease activity using 10-mm visual analog assessment \[VAS\]); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 less than or equal to (≤3.2) = low disease activity, DAS28 greater than (\>)3.2 to less than or equal to (≤) 5.1=moderate to high disease activity; DAS28 \>5.1=high disease activity.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=117 Participants
Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
|
|---|---|
|
Disease Activity Score Based on 28-Joint Count (DAS28)
Baseline (n=117)
|
6.2 units on a scale
Standard Deviation 1.5
|
|
Disease Activity Score Based on 28-Joint Count (DAS28)
Week 4 (n=116)
|
4.0 units on a scale
Standard Deviation 1.6
|
|
Disease Activity Score Based on 28-Joint Count (DAS28)
Week 8 (n=112)
|
3.3 units on a scale
Standard Deviation 1.4
|
|
Disease Activity Score Based on 28-Joint Count (DAS28)
Week 12 (n=109)
|
2.8 units on a scale
Standard Deviation 1.4
|
|
Disease Activity Score Based on 28-Joint Count (DAS28)
Week 16 (n=106)
|
2.4 units on a scale
Standard Deviation 1.4
|
|
Disease Activity Score Based on 28-Joint Count (DAS28)
Week 20 (n=103)
|
2.1 units on a scale
Standard Deviation 1.2
|
|
Disease Activity Score Based on 28-Joint Count (DAS28)
Week 24 (n=99)
|
2.0 units on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit.
DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 ≤3.2 =low disease activity, DAS28 \>3.2 to ≤5.1=moderate to high disease activity; DAS28 \>5.1=high disease activity.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=117 Participants
Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
|
|---|---|
|
Percentage of Participants by DAS28 Response Category
DAS28 >5.1, Baseline (n=117)
|
73.5 percentage of participants
|
|
Percentage of Participants by DAS28 Response Category
DAS28 ≤3.2, Baseline (n=117)
|
0.9 percentage of participants
|
|
Percentage of Participants by DAS28 Response Category
DAS28 ≤3.2, Week 4 (n=116)
|
31.9 percentage of participants
|
|
Percentage of Participants by DAS28 Response Category
DAS28 ≤3.2, Week 8 (n=112)
|
50.9 percentage of participants
|
|
Percentage of Participants by DAS28 Response Category
DAS28 ≤3.2, Week 12 (n=109)
|
67.9 percentage of participants
|
|
Percentage of Participants by DAS28 Response Category
DAS28 ≤3.2, Week 16 (n=106)
|
81.1 percentage of participants
|
|
Percentage of Participants by DAS28 Response Category
DAS28 ≤3.2, Week 20 (n=103)
|
88.3 percentage of participants
|
|
Percentage of Participants by DAS28 Response Category
DAS28 ≤3.2, Week 24 (n=99)
|
83.8 percentage of participants
|
|
Percentage of Participants by DAS28 Response Category
DAS28 >3.2 and ≤5.1, Baseline (n=117)
|
25.6 percentage of participants
|
|
Percentage of Participants by DAS28 Response Category
DAS28 >3.2 and ≤5.1, Week 4 (n=116)
|
43.1 percentage of participants
|
|
Percentage of Participants by DAS28 Response Category
DAS28 >3.2 and ≤5.1, Week 8 (n=112)
|
40.2 percentage of participants
|
|
Percentage of Participants by DAS28 Response Category
DAS28 >3.2 and ≤5.1, Week 12 (n=109)
|
25.7 percentage of participants
|
|
Percentage of Participants by DAS28 Response Category
DAS28 >3.2 and ≤5.1, Week 16 (n=106)
|
13.2 percentage of participants
|
|
Percentage of Participants by DAS28 Response Category
DAS28 >3.2 and ≤5.1, Week 20 (n=103)
|
9.7 percentage of participants
|
|
Percentage of Participants by DAS28 Response Category
DAS28 >3.2 and ≤5.1, Week 24 (n=99)
|
13.1 percentage of participants
|
|
Percentage of Participants by DAS28 Response Category
DAS28 >5.1, Week 4 (n=116)
|
25.0 percentage of participants
|
|
Percentage of Participants by DAS28 Response Category
DAS28 >5.1, Week 8 (n=112)
|
8.9 percentage of participants
|
|
Percentage of Participants by DAS28 Response Category
DAS28 >5.1, Week 12 (n=109)
|
6.4 percentage of participants
|
|
Percentage of Participants by DAS28 Response Category
DAS28 >5.1, Week 16 (n=106)
|
5.7 percentage of participants
|
|
Percentage of Participants by DAS28 Response Category
DAS28 >5.1, Week 20 (n=103)
|
1.9 percentage of participants
|
|
Percentage of Participants by DAS28 Response Category
DAS28 >5.1, Week 24 (n=99)
|
3.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: ITT Population
DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. A reduction in DAS28 of at least 1.2 units was considered a clinically meaningful improvement.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=117 Participants
Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
|
|---|---|
|
Percentage of Participants With a Clinically Meaningful Improvement in Disease Activity
Baseline
|
0 percentage of participants
|
|
Percentage of Participants With a Clinically Meaningful Improvement in Disease Activity
Week 4
|
76.7 percentage of participants
|
|
Percentage of Participants With a Clinically Meaningful Improvement in Disease Activity
Week 8
|
91.1 percentage of participants
|
|
Percentage of Participants With a Clinically Meaningful Improvement in Disease Activity
Week 12
|
91.7 percentage of participants
|
|
Percentage of Participants With a Clinically Meaningful Improvement in Disease Activity
Week 16
|
96.2 percentage of participants
|
|
Percentage of Participants With a Clinically Meaningful Improvement in Disease Activity
Week 20
|
98.1 percentage of participants
|
|
Percentage of Participants With a Clinically Meaningful Improvement in Disease Activity
Week 24
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: ITT Population
A clinically meaningful improvement in DAS28 was defined as a reduction of at least 1.2 units. Time to achieving clinically meanigful improvement was calculated as the number of days from the first infusion to the first achievement of reduction of 1.2 units in DAS28.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=117 Participants
Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
|
|---|---|
|
Time to Achieve Clinically Meaningful Reduction in DAS28
|
44.7 days
Standard Deviation 29.1
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit.
DAS28 was calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Participants with a DAS28 score \<2.6 were considered to have achieved remission.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=117 Participants
Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
|
|---|---|
|
Percentage of Participants Achieving Remission (DAS28 <2.6)
Baseline (n=117)
|
0.0 percentage of participants
|
|
Percentage of Participants Achieving Remission (DAS28 <2.6)
Week 4 (n=116)
|
16.4 percentage of participants
|
|
Percentage of Participants Achieving Remission (DAS28 <2.6)
Week 8 (n=112)
|
30.4 percentage of participants
|
|
Percentage of Participants Achieving Remission (DAS28 <2.6)
Week 12 (n=109)
|
48.6 percentage of participants
|
|
Percentage of Participants Achieving Remission (DAS28 <2.6)
Week 16 (n=106)
|
63.2 percentage of participants
|
|
Percentage of Participants Achieving Remission (DAS28 <2.6)
Week 20 (n=103)
|
73.8 percentage of participants
|
|
Percentage of Participants Achieving Remission (DAS28 <2.6)
Week 24 (n=99)
|
74.7 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 16, 20, and 24Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit.
The ACR response rates ACR20, ACR50, ACR70 are defined as ≥20%, ≥50%, ≥70% improvement, respectively, in: swollen joint count (SJC) (66 joints) and tender joint count (TJC) (68 joints) and 3 of the following 5 assessments: Patient assessment of pain (VAS); Patient global assessment of disease activity (VAS); Investigator global assessment of disease activity (VAS); and acute phase response (ESR or CRP)
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=121 Participants
Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
|
|---|---|
|
Percentage of Participants With a Response Assessed Using American College of Rheumatology (ACR) Criteria
ACR20, Week 4 (n=121)
|
62.0 percentage of participants
|
|
Percentage of Participants With a Response Assessed Using American College of Rheumatology (ACR) Criteria
ACR20, Week 8 (n=112)
|
73.2 percentage of participants
|
|
Percentage of Participants With a Response Assessed Using American College of Rheumatology (ACR) Criteria
ACR20, Week 12 (n=109)
|
78.9 percentage of participants
|
|
Percentage of Participants With a Response Assessed Using American College of Rheumatology (ACR) Criteria
ACR20, Week 16 (n=106)
|
85.8 percentage of participants
|
|
Percentage of Participants With a Response Assessed Using American College of Rheumatology (ACR) Criteria
ACR20, Week 20 (n=103)
|
90.3 percentage of participants
|
|
Percentage of Participants With a Response Assessed Using American College of Rheumatology (ACR) Criteria
ACR20, Week 24 (n=99)
|
87.9 percentage of participants
|
|
Percentage of Participants With a Response Assessed Using American College of Rheumatology (ACR) Criteria
ACR50, Week 4 (n=116)
|
27.6 percentage of participants
|
|
Percentage of Participants With a Response Assessed Using American College of Rheumatology (ACR) Criteria
ACR50, Week 8 (n=112)
|
50.0 percentage of participants
|
|
Percentage of Participants With a Response Assessed Using American College of Rheumatology (ACR) Criteria
ACR50, Week 12 (n=109)
|
63.3 percentage of participants
|
|
Percentage of Participants With a Response Assessed Using American College of Rheumatology (ACR) Criteria
ACR50, Week 16 (n=106)
|
77.4 percentage of participants
|
|
Percentage of Participants With a Response Assessed Using American College of Rheumatology (ACR) Criteria
ACR50, Week 20 (n=103)
|
85.4 percentage of participants
|
|
Percentage of Participants With a Response Assessed Using American College of Rheumatology (ACR) Criteria
ACR50, Week 24 (n=99)
|
80.8 percentage of participants
|
|
Percentage of Participants With a Response Assessed Using American College of Rheumatology (ACR) Criteria
ACR70, Week 4 (n=115)
|
6.9 percentage of participants
|
|
Percentage of Participants With a Response Assessed Using American College of Rheumatology (ACR) Criteria
ACR70, Week 8 (n=112)
|
29.5 percentage of participants
|
|
Percentage of Participants With a Response Assessed Using American College of Rheumatology (ACR) Criteria
ACR70, Week 12 (n=109)
|
32.1 percentage of participants
|
|
Percentage of Participants With a Response Assessed Using American College of Rheumatology (ACR) Criteria
ACR70, Week 16 (n=106)
|
48.1 percentage of participants
|
|
Percentage of Participants With a Response Assessed Using American College of Rheumatology (ACR) Criteria
ACR70, Week 20 (n=103)
|
56.3 percentage of participants
|
|
Percentage of Participants With a Response Assessed Using American College of Rheumatology (ACR) Criteria
ACR70, Week 24 (n=99)
|
61.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: ITT Population
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). 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). The change in SJC and TJC was determined as the difference in values from baseline at each visit.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=117 Participants
Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
|
|---|---|
|
Swollen and Tender Joint Counts
SJC Week 12
|
2.8 joints
Standard Deviation 4.5
|
|
Swollen and Tender Joint Counts
SJC Baseline
|
10.8 joints
Standard Deviation 7.4
|
|
Swollen and Tender Joint Counts
SJC Week 4
|
4.8 joints
Standard Deviation 6.0
|
|
Swollen and Tender Joint Counts
Change in SJC at Week 4
|
6.0 joints
Standard Deviation 6.5
|
|
Swollen and Tender Joint Counts
SJC Week 8
|
3.1 joints
Standard Deviation 4.6
|
|
Swollen and Tender Joint Counts
Change in SJC at Week 8
|
7.5 joints
Standard Deviation 6.8
|
|
Swollen and Tender Joint Counts
Change in SJC at Week 12
|
7.8 joints
Standard Deviation 6.9
|
|
Swollen and Tender Joint Counts
SJC Week 16
|
1.8 joints
Standard Deviation 3.4
|
|
Swollen and Tender Joint Counts
Change in SJC at Week 16
|
8.9 joints
Standard Deviation 7.4
|
|
Swollen and Tender Joint Counts
SJC Week 20
|
0.9 joints
Standard Deviation 1.9
|
|
Swollen and Tender Joint Counts
Change in SJC at Week 20
|
9.8 joints
Standard Deviation 7.4
|
|
Swollen and Tender Joint Counts
SJC Week 24
|
1.0 joints
Standard Deviation 2.2
|
|
Swollen and Tender Joint Counts
Change in SJC at Week 24
|
9.9 joints
Standard Deviation 7.6
|
|
Swollen and Tender Joint Counts
TJC Baseline
|
15.4 joints
Standard Deviation 8.8
|
|
Swollen and Tender Joint Counts
TJC Week 4
|
9.3 joints
Standard Deviation 7.7
|
|
Swollen and Tender Joint Counts
Change in TJC at Week 4
|
6.1 joints
Standard Deviation 7.6
|
|
Swollen and Tender Joint Counts
TJC Week 8
|
6.2 joints
Standard Deviation 5.7
|
|
Swollen and Tender Joint Counts
Change in TJC at Week 8
|
9.1 joints
Standard Deviation 7.2
|
|
Swollen and Tender Joint Counts
TJC Week 12
|
4.7 joints
Standard Deviation 5.8
|
|
Swollen and Tender Joint Counts
Change in TJC at Week 12
|
10.4 joints
Standard Deviation 7.4
|
|
Swollen and Tender Joint Counts
TJC Week 16
|
3.3 joints
Standard Deviation 4.5
|
|
Swollen and Tender Joint Counts
Change in TJC at Week 16
|
12.0 joints
Standard Deviation 7.6
|
|
Swollen and Tender Joint Counts
TJC Week 20
|
2.5 joints
Standard Deviation 3.5
|
|
Swollen and Tender Joint Counts
Change in TJC at Week 20
|
12.7 joints
Standard Deviation 7.8
|
|
Swollen and Tender Joint Counts
TJC Week 24
|
2.3 joints
Standard Deviation 4.1
|
|
Swollen and Tender Joint Counts
Change in TJC at Week 24
|
13.0 joints
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: ITT Population
HAQ 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 change in HAQ was determined as the difference in values from baseline at each visit.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=117 Participants
Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
|
|---|---|
|
Health Assessment Questionnaire (HAQ)
Baseline
|
1.97 score on a scale
Standard Deviation 0.82
|
|
Health Assessment Questionnaire (HAQ)
Week 4
|
1.44 score on a scale
Standard Deviation 0.83
|
|
Health Assessment Questionnaire (HAQ)
Change at Week 4
|
0.52 score on a scale
Standard Deviation 0.55
|
|
Health Assessment Questionnaire (HAQ)
Week 8
|
1.02 score on a scale
Standard Deviation 0.73
|
|
Health Assessment Questionnaire (HAQ)
Change at Week 8
|
0.94 score on a scale
Standard Deviation 0.72
|
|
Health Assessment Questionnaire (HAQ)
Week 12
|
0.80 score on a scale
Standard Deviation 0.70
|
|
Health Assessment Questionnaire (HAQ)
Change at Week 12
|
1.14 score on a scale
Standard Deviation 0.79
|
|
Health Assessment Questionnaire (HAQ)
Week 16
|
0.70 score on a scale
Standard Deviation 0.77
|
|
Health Assessment Questionnaire (HAQ)
Change at Week 16
|
1.24 score on a scale
Standard Deviation 0.91
|
|
Health Assessment Questionnaire (HAQ)
Week 20
|
0.56 score on a scale
Standard Deviation 0.66
|
|
Health Assessment Questionnaire (HAQ)
Change at Week 20
|
1.33 score on a scale
Standard Deviation 0.86
|
|
Health Assessment Questionnaire (HAQ)
HAQ Week 24
|
0.56 score on a scale
Standard Deviation 0.69
|
|
Health Assessment Questionnaire (HAQ)
Change at Week 24
|
1.32 score on a scale
Standard Deviation 0.87
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: ITT Population
The participant's overall assessment of their current disease activity was displayed on a 100-mm horizontal VAS. The left-hand extreme (0 mm) of the line was described as "no disease activity" (symptom free and no arthritis symptoms) and the right-hand extreme (100 mm) was described as "maximum disease activity" (maximum arthritis disease activity). The change in Patient Global Assessment of Disease Activity was determined as the difference in values from baseline at each visit.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=117 Participants
Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
|
|---|---|
|
Patient Global Assessment of Disease Activity (VAS)
Baseline
|
64.2 mm
Standard Deviation 18.6
|
|
Patient Global Assessment of Disease Activity (VAS)
Change at Week 16
|
46.4 mm
Standard Deviation 25.2
|
|
Patient Global Assessment of Disease Activity (VAS)
Week 4
|
40.6 mm
Standard Deviation 20.7
|
|
Patient Global Assessment of Disease Activity (VAS)
Change at Week 4
|
23.6 mm
Standard Deviation 21.5
|
|
Patient Global Assessment of Disease Activity (VAS)
Week 8
|
28.8 mm
Standard Deviation 19.8
|
|
Patient Global Assessment of Disease Activity (VAS)
Change at Week 8
|
35.6 mm
Standard Deviation 22.0
|
|
Patient Global Assessment of Disease Activity (VAS)
Week 12
|
21.4 mm
Standard Deviation 18.1
|
|
Patient Global Assessment of Disease Activity (VAS)
Change at Week 12
|
42.8 mm
Standard Deviation 23.8
|
|
Patient Global Assessment of Disease Activity (VAS)
Week 16
|
18.1 mm
Standard Deviation 19.2
|
|
Patient Global Assessment of Disease Activity (VAS)
Week 20
|
11.3 mm
Standard Deviation 12.3
|
|
Patient Global Assessment of Disease Activity (VAS)
Change at Week 20
|
53.0 mm
Standard Deviation 22.0
|
|
Patient Global Assessment of Disease Activity (VAS)
Week 24
|
12.0 mm
Standard Deviation 15.3
|
|
Patient Global Assessment of Disease Activity (VAS)
Change at Week 24
|
51.6 mm
Standard Deviation 25.3
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: ITT Population
The physician's assessment of the participant's current disease activity was displayed on a 100-mm horizontal VAS. The left-hand extreme of the line (0 mm) was described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme (100 mm) was described as "maximum disease activity". The Physician's Global Assessment of Disease Activity was completed by the Efficacy Assessor who could or could not be a physician. The change in Physician's Global Assessment of Disease Activity was determined as the difference in values from baseline at each visit.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=117 Participants
Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
|
|---|---|
|
Physician's Global Assessment of Disease Activity (VAS)
Baseline
|
61.8 mm
Standard Deviation 18.3
|
|
Physician's Global Assessment of Disease Activity (VAS)
Week 4
|
37.7 mm
Standard Deviation 20.5
|
|
Physician's Global Assessment of Disease Activity (VAS)
Change at Week 4
|
24.3 mm
Standard Deviation 20.3
|
|
Physician's Global Assessment of Disease Activity (VAS)
Week 8
|
26.7 mm
Standard Deviation 19.4
|
|
Physician's Global Assessment of Disease Activity (VAS)
Change at Week 8
|
35.4 mm
Standard Deviation 21.7
|
|
Physician's Global Assessment of Disease Activity (VAS)
Week 12
|
20.0 mm
Standard Deviation 17.3
|
|
Physician's Global Assessment of Disease Activity (VAS)
Change at Week 12
|
41.6 mm
Standard Deviation 23.5
|
|
Physician's Global Assessment of Disease Activity (VAS)
Week 16
|
16.0 mm
Standard Deviation 18.8
|
|
Physician's Global Assessment of Disease Activity (VAS)
Change at Week 16
|
46.0 mm
Standard Deviation 24.6
|
|
Physician's Global Assessment of Disease Activity (VAS)
Week 20
|
10.0 mm
Standard Deviation 10.9
|
|
Physician's Global Assessment of Disease Activity (VAS)
Change at Week 20
|
51.8 mm
Standard Deviation 21.0
|
|
Physician's Global Assessment of Disease Activity (VAS)
Week 24
|
10.7 mm
Standard Deviation 13.2
|
|
Physician's Global Assessment of Disease Activity (VAS)
Change at Week 24
|
50.6 mm
Standard Deviation 23.3
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: ITT Population
The participant's assessment of their current level of pain was displayed on a 100-mm horizontal VAS. The left-hand extreme (0 mm) of the line was described as "no pain" and the right-hand extreme of the line (100 mm) was described as "unbearable pain". The change in participant's perception of pain was determined as the difference in values from baseline at each visit.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=117 Participants
Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
|
|---|---|
|
Patient Assessment of of Pain (VAS)
Week 20
|
10.6 mm
Standard Deviation 10.9
|
|
Patient Assessment of of Pain (VAS)
Change at Week 20
|
52.3 mm
Standard Deviation 21.8
|
|
Patient Assessment of of Pain (VAS)
Week 24
|
11.3 mm
Standard Deviation 14.3
|
|
Patient Assessment of of Pain (VAS)
Change at Week 24
|
51.5 mm
Standard Deviation 25.4
|
|
Patient Assessment of of Pain (VAS)
Baseline
|
63.4 mm
Standard Deviation 18.7
|
|
Patient Assessment of of Pain (VAS)
Week 4
|
41.4 mm
Standard Deviation 21.1
|
|
Patient Assessment of of Pain (VAS)
Change at Week 4
|
21.9 mm
Standard Deviation 20.7
|
|
Patient Assessment of of Pain (VAS)
Week 8
|
29.1 mm
Standard Deviation 21.0
|
|
Patient Assessment of of Pain (VAS)
Change at Week 8
|
34.5 mm
Standard Deviation 23.1
|
|
Patient Assessment of of Pain (VAS)
Week 12
|
21.4 mm
Standard Deviation 18.1
|
|
Patient Assessment of of Pain (VAS)
Change at Week 12
|
41.7 mm
Standard Deviation 24.1
|
|
Patient Assessment of of Pain (VAS)
Week 16
|
16.3 mm
Standard Deviation 17.7
|
|
Patient Assessment of of Pain (VAS)
Change at Week 16
|
46.6 mm
Standard Deviation 24.5
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: ITT Population
CRP is an acute phase inflammatory marker. Levels of CRP increase with inflammation. The change in CRP was determined as the difference in values from baseline and at each visit.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=117 Participants
Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
|
|---|---|
|
C-Reactive Protein (CRP)
Baseline
|
22.9 mg/dL
Standard Deviation 24.1
|
|
C-Reactive Protein (CRP)
Week 4
|
6.5 mg/dL
Standard Deviation 14.8
|
|
C-Reactive Protein (CRP)
Change at Week 4
|
16.6 mg/dL
Standard Deviation 27.3
|
|
C-Reactive Protein (CRP)
Week 8
|
4.9 mg/dL
Standard Deviation 6.4
|
|
C-Reactive Protein (CRP)
Change at Week 8
|
17.7 mg/dL
Standard Deviation 23.1
|
|
C-Reactive Protein (CRP)
Week 12
|
5.1 mg/dL
Standard Deviation 9.4
|
|
C-Reactive Protein (CRP)
Change at Week 12
|
16.8 mg/dL
Standard Deviation 24.3
|
|
C-Reactive Protein (CRP)
Week 16
|
5.2 mg/dL
Standard Deviation 7.5
|
|
C-Reactive Protein (CRP)
Change at Week 16
|
17.2 mg/dL
Standard Deviation 23.3
|
|
C-Reactive Protein (CRP)
Week 20
|
6.1 mg/dL
Standard Deviation 11.6
|
|
C-Reactive Protein (CRP)
Change at Week 20
|
16.0 mg/dL
Standard Deviation 24.1
|
|
C-Reactive Protein (CRP)
Week 24
|
6.7 mg/dL
Standard Deviation 8.7
|
|
C-Reactive Protein (CRP)
Change at Week 24
|
16.1 mg/dL
Standard Deviation 24.3
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, and 24Population: ITT Population
ESR indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation. The change in ESR was determined as the difference in values from baseline at each visit.
Outcome measures
| Measure |
Tocilizumab 8 mg/kg
n=117 Participants
Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
|
|---|---|
|
Erythrocyte Sedimentation Rate (ESR)
Baseline
|
31.4 mm/hr
Standard Deviation 23.3
|
|
Erythrocyte Sedimentation Rate (ESR)
Week 4
|
9.5 mm/hr
Standard Deviation 11.7
|
|
Erythrocyte Sedimentation Rate (ESR)
Change at Week 4
|
21.8 mm/hr
Standard Deviation 20.1
|
|
Erythrocyte Sedimentation Rate (ESR)
Week 8
|
8.3 mm/hr
Standard Deviation 11.6
|
|
Erythrocyte Sedimentation Rate (ESR)
Change at Week 8
|
22.4 mm/hr
Standard Deviation 20.7
|
|
Erythrocyte Sedimentation Rate (ESR)
Week 12
|
8.6 mm/hr
Standard Deviation 12.0
|
|
Erythrocyte Sedimentation Rate (ESR)
Change at Week 12
|
22.9 mm/hr
Standard Deviation 21.3
|
|
Erythrocyte Sedimentation Rate (ESR)
Week 16
|
8.1 mm/hr
Standard Deviation 13.0
|
|
Erythrocyte Sedimentation Rate (ESR)
Change at Week 16
|
23.0 mm/hr
Standard Deviation 18.9
|
|
Erythrocyte Sedimentation Rate (ESR)
Week 20
|
7.8 mm/hr
Standard Deviation 11.3
|
|
Erythrocyte Sedimentation Rate (ESR)
Change at Week 20
|
22.4 mm/hr
Standard Deviation 19.4
|
|
Erythrocyte Sedimentation Rate (ESR)
Week 24
|
8.2 mm/hr
Standard Deviation 9.7
|
|
Erythrocyte Sedimentation Rate (ESR)
Change at Week 24
|
22.2 mm/hr
Standard Deviation 2.4
|
Adverse Events
Tocilizumab 8 mg/kg
Serious events: 13 serious events
Other events: 59 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tocilizumab 8 mg/kg
n=121 participants at risk
Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
0.83%
1/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Vascular disorders
Hypertension
|
1.7%
2/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.83%
1/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
2.5%
3/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Musculoskeletal and connective tissue disorders
Worsening of arthralgia
|
0.83%
1/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Infections and infestations
Necrotising fasciitis
|
0.83%
1/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Infections and infestations
Pneumonia
|
1.7%
2/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Infections and infestations
Bronchitis
|
0.83%
1/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervical cancer
|
0.83%
1/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
Other adverse events
| Measure |
Tocilizumab 8 mg/kg
n=121 participants at risk
Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
|
|---|---|
|
Investigations
Elevation of the AST/ALT levels
|
18.2%
22/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Investigations
Hypercholesterolemia
|
14.9%
18/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Investigations
Hypertriglyceridemia
|
13.2%
16/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Investigations
Bilirubin level elevations
|
12.4%
15/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Blood and lymphatic system disorders
Neutropenia
|
9.9%
12/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.6%
8/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Blood and lymphatic system disorders
Leucopenia
|
4.1%
5/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Blood and lymphatic system disorders
Anaemia
|
4.1%
5/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Blood and lymphatic system disorders
Increased neutrophil count
|
3.3%
4/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
3.3%
4/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
3.3%
4/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Nervous system disorders
Headache
|
2.5%
3/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
3/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Investigations
Alkaline phosphatase elevations
|
2.5%
3/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Infections and infestations
Bronchitis
|
2.5%
3/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Gastrointestinal disorders
Gingivitis
|
1.7%
2/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Nervous system disorders
Vertigo
|
1.7%
2/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
2/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.7%
2/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.7%
2/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
General disorders
Fatigue
|
1.7%
2/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.7%
2/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Blood and lymphatic system disorders
Increased leukocyte count
|
1.7%
2/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Vascular disorders
Hypertension
|
1.7%
2/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
1.7%
2/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Infections and infestations
Pneumonia
|
1.7%
2/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
General disorders
Oedema limbs
|
0.83%
1/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Skin and subcutaneous tissue disorders
Bullous lesions
|
0.83%
1/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Infections and infestations
Necrotising fasciitis
|
0.83%
1/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Musculoskeletal and connective tissue disorders
Stiffness
|
0.83%
1/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
General disorders
Fever
|
0.83%
1/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Gastrointestinal disorders
Gastralgia
|
0.83%
1/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
General disorders
Swelling of the upper and lower limbs
|
0.83%
1/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
General disorders
Chest pain
|
0.83%
1/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Infections and infestations
Tooth abscess
|
0.83%
1/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
General disorders
Zona
|
0.83%
1/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Blood and lymphatic system disorders
Inguinal adenopathy
|
0.83%
1/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
General disorders
Inflammation at the site of infusion
|
0.83%
1/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Infections and infestations
Nasopharyngitis
|
0.83%
1/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Infections and infestations
Paronychia
|
0.83%
1/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Nervous system disorders
Tingling
|
0.83%
1/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
General disorders
Chills
|
0.83%
1/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Musculoskeletal and connective tissue disorders
Leg cramps
|
0.83%
1/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Investigations
Decreased level of HDL cholesterol
|
0.83%
1/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Investigations
Elevation of creatine level
|
0.83%
1/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.83%
1/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.83%
1/121 • Adverse events (AE) were recorded from the date of first infusion to the end of study visit at Week 24.
An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
|
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