Trial Outcomes & Findings for A Long-term Safety Extension Study of Tocilizumab in Brazilian Participants With Rheumatoid Arthritis (RA) Who Completed the Studies ML21530 and MA21488 (NCT NCT01715831)
NCT ID: NCT01715831
Last Updated: 2017-06-12
Results Overview
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; significant medical event, according to the investigator discretion (e.g., may represent a risk to the participant or may require medical/surgical intervention to prevent one of the outcomes mentioned above).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
26 participants
Primary outcome timeframe
From Baseline up to approximately 2 years
Results posted on
2017-06-12
Participant Flow
Participant milestones
| Measure |
Tocilizumab
Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received disease-modifying anti-rheumatic drugs (DMARDs) in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
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Overall Study
STARTED
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26
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Overall Study
COMPLETED
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25
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
Tocilizumab
Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received disease-modifying anti-rheumatic drugs (DMARDs) in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
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Overall Study
Adverse Event
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1
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Baseline Characteristics
A Long-term Safety Extension Study of Tocilizumab in Brazilian Participants With Rheumatoid Arthritis (RA) Who Completed the Studies ML21530 and MA21488
Baseline characteristics by cohort
| Measure |
Tocilizumab
n=26 Participants
Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
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|---|---|
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Age, Continuous
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56.0 years
STANDARD_DEVIATION 12.6 • n=5 Participants
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Sex: Female, Male
Female
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25 Participants
n=5 Participants
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Sex: Female, Male
Male
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1 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: From Baseline up to approximately 2 yearsPopulation: ITT population
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; significant medical event, according to the investigator discretion (e.g., may represent a risk to the participant or may require medical/surgical intervention to prevent one of the outcomes mentioned above).
Outcome measures
| Measure |
Tocilizumab
n=26 Participants
Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
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Number of Participants With Serious Adverse Events (SAEs) and Non-Serious Adverse Events (NSAEs)
SAEs
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4 participants
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Number of Participants With Serious Adverse Events (SAEs) and Non-Serious Adverse Events (NSAEs)
NSAEs
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24 participants
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PRIMARY outcome
Timeframe: From Baseline up to approximately 2 yearsPopulation: ITT population
Outcome measures
| Measure |
Tocilizumab
n=26 Participants
Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
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Number of Participants With AEs Leading to Dose Modification or Study Discontinuation
AEs leading to dose modification
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7 participants
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Number of Participants With AEs Leading to Dose Modification or Study Discontinuation
AEs leading to study discontinuation
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1 participants
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PRIMARY outcome
Timeframe: From Baseline up to approximately 2 yearsPopulation: ITT population
Adverse events of special interest included following events: Infections (including opportunistic infections); myocardial infarction / acute coronary syndrome; gastrointestinal (GI) perforations and related events; malignancies; anaphylaxis/hypersensitivity reactions; demyelinating disorders; stroke; hemorrhagic events; and hepatic events. Overall number of participants who experienced any of these AEs of special interest was reported.
Outcome measures
| Measure |
Tocilizumab
n=26 Participants
Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
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Number of Participants With AEs of Special Interest
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0 participants
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SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and follow-up (FU) Visit 1 (Week 108), FU Visit 2 (Week 116)Population: ITT population. Here, n=Number of participants analyzed for this outcome measure at specified timepoint.
DAS28 score is a measure of participant's disease activity calculated using tender joint count in 28 joints (TJC28), swollen joint count in 28 joints (SJC28), participant's global assessment of disease activity (general health \[GH\]) using visual analog scale (VAS), 0 millimeter (mm)=no disease activity to 100 mm=maximum disease activity, displayed on the 100 mm horizontal VAS, and acute phase response (erythrocyte sedimentation rate \[ESR\] in millimeters per hour \[mm/hr\]) for a total possible score of 0 to 10. The score is calculated using the following formula: DAS28 = \[0.56 multiplied by (\*) square root (√) of TJC28\] plus (+) \[0.28\*√SJC28\]+\[0.70\*the natural logarithm (ln) ESR\]+\[0.014\*GH\]. DAS28-ESR score varies from 0 to 10, where higher scores represent greater disease activity.
Outcome measures
| Measure |
Tocilizumab
n=26 Participants
Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
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Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR)
Baseline (n=26)
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2.76 units on a scale
Standard Deviation 1.19
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Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR)
Week 12 (n=24)
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2.23 units on a scale
Standard Deviation 0.86
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Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR)
Week 24 (n=25)
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2.43 units on a scale
Standard Deviation 1.01
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Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR)
Week 36 (n=25)
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2.04 units on a scale
Standard Deviation 0.85
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Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR)
Week 48 (n=21)
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2.32 units on a scale
Standard Deviation 1.23
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Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR)
Week 56 (n=24)
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1.82 units on a scale
Standard Deviation 0.55
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Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR)
Week 68 (n=23)
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2.21 units on a scale
Standard Deviation 0.84
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Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR)
Week 80 (n=24)
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2.06 units on a scale
Standard Deviation 0.64
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Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR)
Week 92 (n=24)
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2.23 units on a scale
Standard Deviation 0.96
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Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR)
Week 104 (n=25)
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1.92 units on a scale
Standard Deviation 0.93
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Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR)
FU Visit 1 (n=13)
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1.70 units on a scale
Standard Deviation 1.02
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Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR)
FU Visit 2 (n=24)
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3.21 units on a scale
Standard Deviation 1.35
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SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)Population: ITT population. Here, n=Number of participants analyzed for this outcome measure at specified timepoint.
An assessment of 28 joints was conducted for tenderness. Joints were assessed and classified as tender/not tender by pressure and joint manipulation after a physical examination. Artificial joints, arthrodesis or fused joints were not taken into consideration for tenderness.
Outcome measures
| Measure |
Tocilizumab
n=26 Participants
Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
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Tender Joint Count (TJC)
Baseline (n=26)
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2.8 tender joints
Standard Deviation 3.6
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Tender Joint Count (TJC)
Week 12 (n=24)
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1.8 tender joints
Standard Deviation 2.3
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Tender Joint Count (TJC)
Week 24 (n=25)
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2.0 tender joints
Standard Deviation 3.6
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Tender Joint Count (TJC)
Week 36 (n=25)
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1.9 tender joints
Standard Deviation 2.5
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Tender Joint Count (TJC)
Week 48 (n=21)
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2.8 tender joints
Standard Deviation 3.8
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Tender Joint Count (TJC)
Week 56 (n=24)
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1.1 tender joints
Standard Deviation 1.2
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Tender Joint Count (TJC)
Week 68 (n=23)
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2.0 tender joints
Standard Deviation 2.6
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Tender Joint Count (TJC)
Week 80 (n=24)
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1.6 tender joints
Standard Deviation 2.0
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Tender Joint Count (TJC)
Week 92 (n=24)
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1.5 tender joints
Standard Deviation 1.7
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Tender Joint Count (TJC)
Week 104 (n=25)
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1.5 tender joints
Standard Deviation 1.8
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Tender Joint Count (TJC)
FU Visit 1 (n=13)
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1.8 tender joints
Standard Deviation 3.7
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Tender Joint Count (TJC)
FU Visit 2 (n=24)
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2.8 tender joints
Standard Deviation 4.7
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SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)Population: ITT population. Here, n=Number of participants analyzed for this outcome measure at specified timepoint.
An assessment of 28 joints was conducted for swelling. Joints were assessed and classified as swollen/not swollen by pressure and joint manipulation after a physical examination. Artificial joints, arthrodesis or fused joints were not taken into consideration for swelling.
Outcome measures
| Measure |
Tocilizumab
n=26 Participants
Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
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Swollen Joint Count (SJC)
Baseline (n=26)
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1.4 swollen joints
Standard Deviation 2.0
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Swollen Joint Count (SJC)
Week 12 (n=24)
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1.0 swollen joints
Standard Deviation 2.0
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Swollen Joint Count (SJC)
Week 24 (n=25)
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0.6 swollen joints
Standard Deviation 1.2
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Swollen Joint Count (SJC)
Week 36 (n=25)
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0.9 swollen joints
Standard Deviation 1.0
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Swollen Joint Count (SJC)
Week 48 (n=21)
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1.4 swollen joints
Standard Deviation 2.5
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Swollen Joint Count (SJC)
Week 56 (n=24)
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0.8 swollen joints
Standard Deviation 1.8
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Swollen Joint Count (SJC)
Week 68 (n=23)
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0.9 swollen joints
Standard Deviation 1.5
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Swollen Joint Count (SJC)
Week 80 (n=24)
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0.4 swollen joints
Standard Deviation 0.8
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Swollen Joint Count (SJC)
Week 92 (n=24)
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0.8 swollen joints
Standard Deviation 1.2
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Swollen Joint Count (SJC)
Week 104 (n=25)
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0.6 swollen joints
Standard Deviation 1.3
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Swollen Joint Count (SJC)
FU Visit 1 (n=13)
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0.2 swollen joints
Standard Deviation 0.4
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Swollen Joint Count (SJC)
FU Visit 2 (n=24)
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1.5 swollen joints
Standard Deviation 2.2
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SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)Population: ITT population. Here, n=Number of participants analyzed for this outcome measure at specified timepoint.
Participant's global assessment of disease activity was measured on a horizontal 0-100 mm VAS, with 0 mm (left end of the line) described as "inactive disease" (free of symptoms and without symptoms of arthritis) and 100 mm (right end of the line) as "disease maximum activity" (maximum activity of arthritis). The participant marked the line according to their assessment and the distance from the left edge was measured.
Outcome measures
| Measure |
Tocilizumab
n=26 Participants
Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
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Global Evaluation of Disease Activity by the Participant Using VAS Score
Baseline (n=26)
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35.2 mm
Standard Deviation 25.3
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Global Evaluation of Disease Activity by the Participant Using VAS Score
Week 12 (n=26)
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36.4 mm
Standard Deviation 26.4
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Global Evaluation of Disease Activity by the Participant Using VAS Score
Week 24 (n=26)
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38.4 mm
Standard Deviation 27.2
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Global Evaluation of Disease Activity by the Participant Using VAS Score
Week 36 (n=25)
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31.8 mm
Standard Deviation 25.0
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Global Evaluation of Disease Activity by the Participant Using VAS Score
Week 48 (n=23)
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32.8 mm
Standard Deviation 28.8
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Global Evaluation of Disease Activity by the Participant Using VAS Score
Week 56 (n=25)
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30.6 mm
Standard Deviation 22.7
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Global Evaluation of Disease Activity by the Participant Using VAS Score
Week 68 (n=24)
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32.4 mm
Standard Deviation 24.6
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Global Evaluation of Disease Activity by the Participant Using VAS Score
Week 80 (n=24)
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36.1 mm
Standard Deviation 26.2
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Global Evaluation of Disease Activity by the Participant Using VAS Score
Week 92 (n=25)
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36.2 mm
Standard Deviation 25.5
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Global Evaluation of Disease Activity by the Participant Using VAS Score
Week 104 (n=25)
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33.4 mm
Standard Deviation 25.2
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Global Evaluation of Disease Activity by the Participant Using VAS Score
FU Visit 1 (n=15)
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37.1 mm
Standard Deviation 28.0
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Global Evaluation of Disease Activity by the Participant Using VAS Score
FU Visit 2 (n=25)
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42.6 mm
Standard Deviation 29.9
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SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)Population: ITT population. Here, n=Number of participants analyzed for this outcome measure at specified timepoint.
Physician global assessment of disease activity was measured on a horizontal 0-100 mm VAS, with 0 mm (left end of the line) described as "inactive disease" (free of symptoms and without symptoms of arthritis) and 100 mm (right end of the line) as "disease maximum activity" (maximum activity of arthritis). The physician marked the line according to their assessment and the distance from the left edge was measured.
Outcome measures
| Measure |
Tocilizumab
n=26 Participants
Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
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Global Evaluation of Disease Activity by the Physician Using VAS Score
Baseline (n=26)
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20.6 mm
Standard Deviation 18.7
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Global Evaluation of Disease Activity by the Physician Using VAS Score
Week 12 (n=26)
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11.4 mm
Standard Deviation 14.1
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Global Evaluation of Disease Activity by the Physician Using VAS Score
Week 24 (n=26)
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13.8 mm
Standard Deviation 14.7
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Global Evaluation of Disease Activity by the Physician Using VAS Score
Week 36 (n=25)
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13.1 mm
Standard Deviation 10.4
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Global Evaluation of Disease Activity by the Physician Using VAS Score
Week 48 (n=23)
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9.1 mm
Standard Deviation 11.3
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Global Evaluation of Disease Activity by the Physician Using VAS Score
Week 56 (n=25)
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13.0 mm
Standard Deviation 13.3
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Global Evaluation of Disease Activity by the Physician Using VAS Score
Week 68 (n=24)
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11.6 mm
Standard Deviation 11.9
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Global Evaluation of Disease Activity by the Physician Using VAS Score
Week 80 (n=24)
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11.3 mm
Standard Deviation 11.2
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Global Evaluation of Disease Activity by the Physician Using VAS Score
Week 92 (n=25)
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13.7 mm
Standard Deviation 11.7
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Global Evaluation of Disease Activity by the Physician Using VAS Score
Week 104 (n=25)
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10.0 mm
Standard Deviation 9.7
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Global Evaluation of Disease Activity by the Physician Using VAS Score
FU Visit 1 (n=15)
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11.7 mm
Standard Deviation 11.5
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Global Evaluation of Disease Activity by the Physician Using VAS Score
FU Visit 2 (n=25)
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15.3 mm
Standard Deviation 18.4
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SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)Population: ITT population. Here, n=Number of participants analyzed for this outcome measure at specified timepoint.
Participant's pain assessment was made on a horizontal 0-100 mm VAS, with 0 mm (left end of the line) described as "no pain" and 100 mm (right end of the line) as "unbearable pain". The participant marked the line according to their assessment and the distance from the left edge was measured.
Outcome measures
| Measure |
Tocilizumab
n=26 Participants
Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
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Participant's Pain Assessment Using VAS Score
Baseline (n=26)
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31.9 mm
Standard Deviation 21.7
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Participant's Pain Assessment Using VAS Score
Week 12 (n=26)
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29.0 mm
Standard Deviation 25.1
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Participant's Pain Assessment Using VAS Score
Week 24 (n=26)
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33.7 mm
Standard Deviation 25.4
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Participant's Pain Assessment Using VAS Score
Week 36 (n=25)
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28.6 mm
Standard Deviation 21.5
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Participant's Pain Assessment Using VAS Score
Week 48 (n=23)
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27.8 mm
Standard Deviation 25.2
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Participant's Pain Assessment Using VAS Score
Week 56 (n=25)
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27.4 mm
Standard Deviation 23.1
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Participant's Pain Assessment Using VAS Score
Week 68 (n=24)
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27.8 mm
Standard Deviation 23.1
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Participant's Pain Assessment Using VAS Score
Week 80 (n=24)
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31.9 mm
Standard Deviation 24.3
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Participant's Pain Assessment Using VAS Score
Week 92 (n=25)
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29.5 mm
Standard Deviation 22.7
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Participant's Pain Assessment Using VAS Score
Week 104 (n=25)
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28.6 mm
Standard Deviation 22.6
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Participant's Pain Assessment Using VAS Score
FU Visit 1 (n=15)
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28.9 mm
Standard Deviation 25.8
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Participant's Pain Assessment Using VAS Score
FU Visit 2 (n=25)
|
42.6 mm
Standard Deviation 30.1
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SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)Population: ITT population. Here, n=Number of participants analyzed for this outcome measure at specified timepoint.
The Stanford HAQ-DI is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/personal care, ability to stand-up, eating, walking, hygiene, reaching, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents 'no disability' and 3 represents 'very severe, high-dependency disability'.
Outcome measures
| Measure |
Tocilizumab
n=26 Participants
Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
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|---|---|
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Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
Baseline (n=26)
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0.68 units on a scale
Standard Deviation 0.61
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Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
Week 12 (n=26)
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0.49 units on a scale
Standard Deviation 0.43
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Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
Week 24 (n=26)
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0.49 units on a scale
Standard Deviation 0.38
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Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
Week 36 (n=25)
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0.49 units on a scale
Standard Deviation 0.45
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Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
Week 48 (n=23)
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0.48 units on a scale
Standard Deviation 0.49
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Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
Week 56 (n=24)
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0.53 units on a scale
Standard Deviation 0.60
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Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
Week 68 (n=24)
|
0.52 units on a scale
Standard Deviation 0.47
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Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
Week 80 (n=24)
|
0.53 units on a scale
Standard Deviation 0.48
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Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
Week 92 (n=23)
|
0.43 units on a scale
Standard Deviation 0.44
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Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
Week 104 (n=24)
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0.48 units on a scale
Standard Deviation 0.50
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Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
FU Visit 1 (n=15)
|
0.56 units on a scale
Standard Deviation 0.42
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Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
FU Visit 2 (n=23)
|
0.63 units on a scale
Standard Deviation 0.59
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SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)Population: ITT population. Here, n=Number of participants analyzed for this outcome measure at specified timepoint.
The HAQ pain VAS is a measure of pain on a continuous 100 mm scale. Participants were asked to indicate how much pain they had in the past week as a result of their illness on a horizontal line from 0 (no pain) to 100 mm (severe pain).
Outcome measures
| Measure |
Tocilizumab
n=26 Participants
Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
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|---|---|
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Health Assessment Questionnaire (HAQ) Pain VAS Score
Baseline (n=26)
|
31.9 mm
Standard Deviation 22.6
|
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Health Assessment Questionnaire (HAQ) Pain VAS Score
Week 12 (n=26)
|
30.8 mm
Standard Deviation 24.5
|
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Health Assessment Questionnaire (HAQ) Pain VAS Score
Week 24 (n=26)
|
37.8 mm
Standard Deviation 26.3
|
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Health Assessment Questionnaire (HAQ) Pain VAS Score
Week 36 (n=25)
|
30.1 mm
Standard Deviation 23.4
|
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Health Assessment Questionnaire (HAQ) Pain VAS Score
Week 48 (n=23)
|
32.7 mm
Standard Deviation 29.4
|
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Health Assessment Questionnaire (HAQ) Pain VAS Score
Week 56 (n=24)
|
31.3 mm
Standard Deviation 24.0
|
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Health Assessment Questionnaire (HAQ) Pain VAS Score
Week 68 (n=24)
|
32.9 mm
Standard Deviation 25.1
|
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Health Assessment Questionnaire (HAQ) Pain VAS Score
Week 80 (n=24)
|
34.4 mm
Standard Deviation 27.2
|
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Health Assessment Questionnaire (HAQ) Pain VAS Score
Week 92 (n=23)
|
38.2 mm
Standard Deviation 30.3
|
|
Health Assessment Questionnaire (HAQ) Pain VAS Score
Week 104 (n=24)
|
29.0 mm
Standard Deviation 23.9
|
|
Health Assessment Questionnaire (HAQ) Pain VAS Score
FU Visit 1 (n=15)
|
30.9 mm
Standard Deviation 24.8
|
|
Health Assessment Questionnaire (HAQ) Pain VAS Score
FU Visit 2 (n=22)
|
43.3 mm
Standard Deviation 32.8
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)Population: ITT population. Here, n=Number of participants analyzed for this outcome measure at specified timepoint.
CRP is an acute phase reactant and is a measure of inflammation.
Outcome measures
| Measure |
Tocilizumab
n=26 Participants
Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
|
|---|---|
|
C-Reactive Protein (CRP) Level
Baseline (n=24)
|
0.51 milligrams per deciliter (mg/dL)
Standard Deviation 0.91
|
|
C-Reactive Protein (CRP) Level
Week 12 (n=26)
|
3.13 milligrams per deciliter (mg/dL)
Standard Deviation 6.17
|
|
C-Reactive Protein (CRP) Level
Week 24 (n=25)
|
1.08 milligrams per deciliter (mg/dL)
Standard Deviation 1.58
|
|
C-Reactive Protein (CRP) Level
Week 36 (n=25)
|
2.58 milligrams per deciliter (mg/dL)
Standard Deviation 3.00
|
|
C-Reactive Protein (CRP) Level
Week 48 (n=21)
|
0.21 milligrams per deciliter (mg/dL)
Standard Deviation 0.27
|
|
C-Reactive Protein (CRP) Level
Week 56 (n=24)
|
0.41 milligrams per deciliter (mg/dL)
Standard Deviation 0.92
|
|
C-Reactive Protein (CRP) Level
Week 68 (n=24)
|
0.43 milligrams per deciliter (mg/dL)
Standard Deviation 0.74
|
|
C-Reactive Protein (CRP) Level
Week 80 (n=24)
|
0.64 milligrams per deciliter (mg/dL)
Standard Deviation 1.91
|
|
C-Reactive Protein (CRP) Level
Week 92 (n=23)
|
1.86 milligrams per deciliter (mg/dL)
Standard Deviation 7.11
|
|
C-Reactive Protein (CRP) Level
Week 104 (n=25)
|
0.12 milligrams per deciliter (mg/dL)
Standard Deviation 0.16
|
|
C-Reactive Protein (CRP) Level
FU Visit 1 (n=13)
|
0.10 milligrams per deciliter (mg/dL)
Standard Deviation 0.11
|
|
C-Reactive Protein (CRP) Level
FU Visit 2 (n=24)
|
1.46 milligrams per deciliter (mg/dL)
Standard Deviation 5.05
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and FU Visit 1 (Week 108), FU Visit 2 (Week 116)Population: ITT population. Here, n=Number of participants analyzed for this outcome measure at specified timepoint.
ESR is an acute phase reactant and is a measure of inflammation.
Outcome measures
| Measure |
Tocilizumab
n=26 Participants
Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
|
|---|---|
|
ESR Level
Baseline (n=26)
|
9.8 mm/hr
Standard Deviation 10.2
|
|
ESR Level
Week 12 (n=24)
|
4.9 mm/hr
Standard Deviation 3.1
|
|
ESR Level
Week 24 (n=25)
|
8.5 mm/hr
Standard Deviation 7.6
|
|
ESR Level
Week 36 (n=25)
|
4.6 mm/hr
Standard Deviation 3.2
|
|
ESR Level
Week 48 (n=21)
|
5.1 mm/hr
Standard Deviation 4.7
|
|
ESR Level
Week 56 (n=24)
|
4.9 mm/hr
Standard Deviation 5.3
|
|
ESR Level
Week 68 (n=23)
|
6.7 mm/hr
Standard Deviation 7.2
|
|
ESR Level
Week 80 (n=24)
|
6.4 mm/hr
Standard Deviation 9.1
|
|
ESR Level
Week 92 (n=24)
|
7.5 mm/hr
Standard Deviation 9.2
|
|
ESR Level
Week 104 (n=25)
|
5.5 mm/hr
Standard Deviation 6.3
|
|
ESR Level
FU Visit 1 (n=13)
|
4.8 mm/hr
Standard Deviation 5.0
|
|
ESR Level
FU Visit 2 (n=24)
|
21.9 mm/hr
Standard Deviation 29.7
|
Adverse Events
Tocilizumab
Serious events: 4 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tocilizumab
n=26 participants at risk
Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
|
|---|---|
|
Nervous system disorders
Ischaemic stroke
|
3.8%
1/26 • From Baseline up to approximately 2 years
ITT population
|
|
Investigations
Total lung capacity decreased
|
3.8%
1/26 • From Baseline up to approximately 2 years
ITT population
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
3.8%
1/26 • From Baseline up to approximately 2 years
ITT population
|
|
Injury, poisoning and procedural complications
Corneal perforation
|
3.8%
1/26 • From Baseline up to approximately 2 years
ITT population
|
|
Gastrointestinal disorders
Diverticulitis
|
3.8%
1/26 • From Baseline up to approximately 2 years
ITT population
|
Other adverse events
| Measure |
Tocilizumab
n=26 participants at risk
Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
|
|---|---|
|
Cardiac disorders
Chest pain
|
7.7%
2/26 • From Baseline up to approximately 2 years
ITT population
|
|
Ear and labyrinth disorders
Labyrinthitis
|
7.7%
2/26 • From Baseline up to approximately 2 years
ITT population
|
|
Gastrointestinal disorders
Dyspepsia
|
15.4%
4/26 • From Baseline up to approximately 2 years
ITT population
|
|
Gastrointestinal disorders
Diarrhoea NOS
|
7.7%
2/26 • From Baseline up to approximately 2 years
ITT population
|
|
Gastrointestinal disorders
Gastritis
|
7.7%
2/26 • From Baseline up to approximately 2 years
ITT population
|
|
Gastrointestinal disorders
Periodontitis
|
7.7%
2/26 • From Baseline up to approximately 2 years
ITT population
|
|
Infections and infestations
Respiratory tract infection NOS
|
46.2%
12/26 • From Baseline up to approximately 2 years
ITT population
|
|
Infections and infestations
Urinary tract infection
|
26.9%
7/26 • From Baseline up to approximately 2 years
ITT population
|
|
Infections and infestations
Tonsillitis
|
15.4%
4/26 • From Baseline up to approximately 2 years
ITT population
|
|
Infections and infestations
Dengue fever
|
7.7%
2/26 • From Baseline up to approximately 2 years
ITT population
|
|
Infections and infestations
Influenza
|
7.7%
2/26 • From Baseline up to approximately 2 years
ITT population
|
|
Injury, poisoning and procedural complications
Injury
|
7.7%
2/26 • From Baseline up to approximately 2 years
ITT population
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
23.1%
6/26 • From Baseline up to approximately 2 years
ITT population
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
11.5%
3/26 • From Baseline up to approximately 2 years
ITT population
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.7%
2/26 • From Baseline up to approximately 2 years
ITT population
|
|
Metabolism and nutrition disorders
Osteopenia
|
7.7%
2/26 • From Baseline up to approximately 2 years
ITT population
|
|
Metabolism and nutrition disorders
Osteoporosis
|
7.7%
2/26 • From Baseline up to approximately 2 years
ITT population
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
7.7%
2/26 • From Baseline up to approximately 2 years
ITT population
|
|
Metabolism and nutrition disorders
Musculoskeletal pain
|
30.8%
8/26 • From Baseline up to approximately 2 years
ITT population
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
2/26 • From Baseline up to approximately 2 years
ITT population
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
2/26 • From Baseline up to approximately 2 years
ITT population
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.7%
2/26 • From Baseline up to approximately 2 years
ITT population
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
7.7%
2/26 • From Baseline up to approximately 2 years
ITT population
|
|
Nervous system disorders
Headache
|
19.2%
5/26 • From Baseline up to approximately 2 years
ITT population
|
|
Psychiatric disorders
Anxiety
|
11.5%
3/26 • From Baseline up to approximately 2 years
ITT population
|
|
Renal and urinary disorders
Leukocyturia
|
7.7%
2/26 • From Baseline up to approximately 2 years
ITT population
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
15.4%
4/26 • From Baseline up to approximately 2 years
ITT population
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
7.7%
2/26 • From Baseline up to approximately 2 years
ITT population
|
|
Respiratory, thoracic and mediastinal disorders
Dermatitis
|
11.5%
3/26 • From Baseline up to approximately 2 years
ITT population
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
11.5%
3/26 • From Baseline up to approximately 2 years
ITT population
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.7%
2/26 • From Baseline up to approximately 2 years
ITT population
|
|
Skin and subcutaneous tissue disorders
Hypertension NOS
|
11.5%
3/26 • From Baseline up to approximately 2 years
ITT 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