Trial Outcomes & Findings for A Long-Term Extension Study to WA19926 (NCT01007435) of Tocilizumab in Participants With Early, Moderate to Severe Rheumatoid Arthritis (NCT NCT01665430)
NCT ID: NCT01665430
Last Updated: 2018-02-08
Results Overview
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs include serious as well as non-serious AEs. AEs of special interest included: Infections including all opportunistic infections and non-serious infections as defined by those treated with IV anti-infectives; Myocardial infarction/acute coronary syndrome; Gastrointestinal perforations and related events; Malignancies; Anaphylaxis/Hypersensitivity reactions; Demyelinating disorders; Stroke; Bleeding events; and Hepatic events.
TERMINATED
PHASE3
38 participants
Baseline up to 112 weeks
2018-02-08
Participant Flow
The study included participants with early, moderate to severe rheumatoid arthritis (RA) who had completed WA19926 (NCT01007435) core study and who may have benefited from tocilizumab treatment based on the Investigator's judgment.
43 participants were initially screened but only 38 participants were enrolled, and started the study.
Participant milestones
| Measure |
Tocilizumab
Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 4 weeks (q4w) up to 104 weeks.
|
|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Tocilizumab
Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 4 weeks (q4w) up to 104 weeks.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Other Unspecified
|
2
|
Baseline Characteristics
A Long-Term Extension Study to WA19926 (NCT01007435) of Tocilizumab in Participants With Early, Moderate to Severe Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Tocilizumab
n=38 Participants
Participants received tocilizumab 8 mg/kg IV infusion q4w up to 104 weeks.
|
|---|---|
|
Age, Continuous
|
52.3 years
STANDARD_DEVIATION 12.12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 112 weeksPopulation: ITT population
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs include serious as well as non-serious AEs. AEs of special interest included: Infections including all opportunistic infections and non-serious infections as defined by those treated with IV anti-infectives; Myocardial infarction/acute coronary syndrome; Gastrointestinal perforations and related events; Malignancies; Anaphylaxis/Hypersensitivity reactions; Demyelinating disorders; Stroke; Bleeding events; and Hepatic events.
Outcome measures
| Measure |
Tocilizumab
n=38 Participants
Participants received tocilizumab 8 mg/kg IV infusion q4w up to 104 weeks.
|
|---|---|
|
Percentage of Participants With Adverse Events (AEs), AEs of Special Interest and Serious Adverse Events (SAEs)
AE
|
65.8 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs), AEs of Special Interest and Serious Adverse Events (SAEs)
AEs of Special Interest
|
34.2 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs), AEs of Special Interest and Serious Adverse Events (SAEs)
SAE
|
7.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, at end of study visit (Week 104), at early withdrawal (up to Week 104)Population: ITT population. Number Analyzed = participants who were evaluable for specified category.
DAS28-ESR was calculated from swollen joint count and tender joint count using 28 joints count, erythrocyte sedimentation rate (ESR, in millimeters per hour \[mm/hour\]) and patient global assessment (PtGA) of disease activity (participant rated arthritis activity assessment on a 0 to 100 millimeter \[mm\] visual analog scale \[VAS\]; higher scores indicating greater affectation due to disease activity). Total DAS28-ESR transformed score range: 0 to approximately 10, higher score=more disease activity. Participants who completed the study, or discontinued the study as per sponsor discretion due to marketing authorization approval, were included in End of Study Visit which was Week 104. Participants who withdrew from the study for the reason other than sponsor discretion due to marketing authorization approval, were included in Early Withdrawal Visit. Participants with "Unspecified" reason of discontinuation were excluded for change from baseline analysis.
Outcome measures
| Measure |
Tocilizumab
n=38 Participants
Participants received tocilizumab 8 mg/kg IV infusion q4w up to 104 weeks.
|
|---|---|
|
Change From Baseline in Disease Activity Index 28 Erythrocyte Sedimentation Rate (DAS28-ESR) Score
Baseline
|
4.365 units on a scale
Standard Deviation 1.5502
|
|
Change From Baseline in Disease Activity Index 28 Erythrocyte Sedimentation Rate (DAS28-ESR) Score
Week 12
|
-1.832 units on a scale
Standard Deviation 1.1985
|
|
Change From Baseline in Disease Activity Index 28 Erythrocyte Sedimentation Rate (DAS28-ESR) Score
Week 24
|
-1.496 units on a scale
Standard Deviation 1.2683
|
|
Change From Baseline in Disease Activity Index 28 Erythrocyte Sedimentation Rate (DAS28-ESR) Score
Week 36
|
-1.904 units on a scale
Standard Deviation 1.1682
|
|
Change From Baseline in Disease Activity Index 28 Erythrocyte Sedimentation Rate (DAS28-ESR) Score
Week 48
|
-1.970 units on a scale
Standard Deviation 1.4503
|
|
Change From Baseline in Disease Activity Index 28 Erythrocyte Sedimentation Rate (DAS28-ESR) Score
Week 56
|
-1.979 units on a scale
Standard Deviation 1.4368
|
|
Change From Baseline in Disease Activity Index 28 Erythrocyte Sedimentation Rate (DAS28-ESR) Score
Week 68
|
-2.069 units on a scale
Standard Deviation 1.2486
|
|
Change From Baseline in Disease Activity Index 28 Erythrocyte Sedimentation Rate (DAS28-ESR) Score
Week 80
|
-1.831 units on a scale
Standard Deviation 1.2592
|
|
Change From Baseline in Disease Activity Index 28 Erythrocyte Sedimentation Rate (DAS28-ESR) Score
Week 92
|
-1.792 units on a scale
Standard Deviation 1.0792
|
|
Change From Baseline in Disease Activity Index 28 Erythrocyte Sedimentation Rate (DAS28-ESR) Score
End of Study
|
-2.187 units on a scale
Standard Deviation 1.1785
|
|
Change From Baseline in Disease Activity Index 28 Erythrocyte Sedimentation Rate (DAS28-ESR) Score
Early Withdrawal
|
-1.624 units on a scale
Standard Deviation 1.8930
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, at end of study visit (Week 104), at early withdrawal (up to Week 104)Population: ITT population. Number Analyzed = participants who were evaluable for specified category.
The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1, for 28 joints and joints were classified as tender/not tender giving a total possible tender joint count of 0 to 28. Participants who completed the study, or discontinued the study as per sponsor discretion due to marketing authorization approval, were included in End of Study Visit which was Week 104. Participants who withdrew from the study for the reason other than sponsor discretion due to marketing authorization approval, were included in Early Withdrawal Visit. Participants with "Unspecified" reason of discontinuation were excluded for change from baseline analysis.
Outcome measures
| Measure |
Tocilizumab
n=38 Participants
Participants received tocilizumab 8 mg/kg IV infusion q4w up to 104 weeks.
|
|---|---|
|
Change From Baseline in Total Tender Joint Counts (28 Joints)
Baseline
|
12.6 tender joints
Standard Deviation 16.54
|
|
Change From Baseline in Total Tender Joint Counts (28 Joints)
Week 12
|
-7.7 tender joints
Standard Deviation 12.63
|
|
Change From Baseline in Total Tender Joint Counts (28 Joints)
Week 24
|
-5.0 tender joints
Standard Deviation 10.95
|
|
Change From Baseline in Total Tender Joint Counts (28 Joints)
Week 36
|
-6.1 tender joints
Standard Deviation 13.13
|
|
Change From Baseline in Total Tender Joint Counts (28 Joints)
Week 48
|
-6.1 tender joints
Standard Deviation 11.17
|
|
Change From Baseline in Total Tender Joint Counts (28 Joints)
Week 56
|
-7.6 tender joints
Standard Deviation 11.89
|
|
Change From Baseline in Total Tender Joint Counts (28 Joints)
Week 68
|
-7.2 tender joints
Standard Deviation 9.63
|
|
Change From Baseline in Total Tender Joint Counts (28 Joints)
Week 80
|
-10.0 tender joints
Standard Deviation 13.74
|
|
Change From Baseline in Total Tender Joint Counts (28 Joints)
Week 92
|
-6.9 tender joints
Standard Deviation 16.10
|
|
Change From Baseline in Total Tender Joint Counts (28 Joints)
End of Study
|
-9.3 tender joints
Standard Deviation 13.61
|
|
Change From Baseline in Total Tender Joint Counts (28 Joints)
Early Withdrawal
|
-6.1 tender joints
Standard Deviation 9.51
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, at end of study visit (Week 104), at early withdrawal (up to Week 104)Population: ITT population. Number Analyzed = participants who were evaluable for specified category.
The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1, for 28 joints and were classified as swollen/not swollen giving a total possible swollen joint count of 0 to 28. Participants who completed the study, or discontinued the study as per sponsor discretion due to marketing authorization approval, were included in End of Study Visit which was Week 104. Participants who withdrew from the study for the reason other than sponsor discretion due to marketing authorization approval, were included in Early Withdrawal Visit. Participants with "Unspecified" reason of discontinuation were excluded for change from baseline analysis.
Outcome measures
| Measure |
Tocilizumab
n=38 Participants
Participants received tocilizumab 8 mg/kg IV infusion q4w up to 104 weeks.
|
|---|---|
|
Change From Baseline in Total Swollen Joint Counts (28 Joints)
Baseline
|
4.8 swollen joints
Standard Deviation 4.67
|
|
Change From Baseline in Total Swollen Joint Counts (28 Joints)
Week 12
|
-2.5 swollen joints
Standard Deviation 3.42
|
|
Change From Baseline in Total Swollen Joint Counts (28 Joints)
Week 24
|
-2.0 swollen joints
Standard Deviation 3.24
|
|
Change From Baseline in Total Swollen Joint Counts (28 Joints)
Week 36
|
-2.1 swollen joints
Standard Deviation 3.61
|
|
Change From Baseline in Total Swollen Joint Counts (28 Joints)
Week 48
|
-2.4 swollen joints
Standard Deviation 3.90
|
|
Change From Baseline in Total Swollen Joint Counts (28 Joints)
Week 56
|
-2.7 swollen joints
Standard Deviation 3.91
|
|
Change From Baseline in Total Swollen Joint Counts (28 Joints)
Week 68
|
-2.9 swollen joints
Standard Deviation 3.90
|
|
Change From Baseline in Total Swollen Joint Counts (28 Joints)
Week 80
|
-2.5 swollen joints
Standard Deviation 4.42
|
|
Change From Baseline in Total Swollen Joint Counts (28 Joints)
Week 92
|
-3.0 swollen joints
Standard Deviation 5.45
|
|
Change From Baseline in Total Swollen Joint Counts (28 Joints)
End of Study
|
-2.8 swollen joints
Standard Deviation 4.12
|
|
Change From Baseline in Total Swollen Joint Counts (28 Joints)
Early Withdrawal
|
-4.3 swollen joints
Standard Deviation 5.28
|
SECONDARY outcome
Timeframe: Baseline up to Week 104 (assessed at Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, at end of study visit [Week 104], at early withdrawal [up to 104 weeks])Population: ITT population
Drug-free remission was defined as having clinical remission (defined as DAS28-ESR score \<2.6) for 2 consecutive assessment visits followed by discontinuation of tocilizumab at the second assessment visit. DAS28-ESR was calculated from swollen joint count and tender joint count using 28 joints count, ESR, (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment on a 0 to 100 mm VAS; higher scores indicating greater affectation due to disease activity). Total DAS28-ESR transformed score range: 0 to approximately 10, higher score=more disease activity.
Outcome measures
| Measure |
Tocilizumab
n=38 Participants
Participants received tocilizumab 8 mg/kg IV infusion q4w up to 104 weeks.
|
|---|---|
|
Percentage of Participants With Drug-Free Remission
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 104 (assessed at Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, at end of study visit [Week 104], at early withdrawal [up to 104 weeks])Population: ITT population
Clinical remission was defined as having DAS28-ESR score \<2.6 at any point during the study. DAS28-ESR was calculated from swollen joint count and tender joint count using 28 joints count, ESR, (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment on a 0 to 100 mm VAS; higher scores indicating greater affectation due to disease activity). Total DAS28-ESR transformed score range: 0 to approximately 10, higher score=more disease activity.
Outcome measures
| Measure |
Tocilizumab
n=38 Participants
Participants received tocilizumab 8 mg/kg IV infusion q4w up to 104 weeks.
|
|---|---|
|
Percentage of Participants With Clinical Remission
|
81.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 104 (assessed at Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, at end of study visit [Week 104], at early withdrawal [up to 104 weeks])Population: The time to RA flare could not be evaluated as none of the participants showed drug-free remission.
Time to RA flare was defined as the period of drug-free remission (having DAS28-ESR score \<2.6 for 2 consecutive assessment visits followed by discontinuation of tocilizumab at the second assessment visit) until documented RA flare. RA flare was defined as any worsening of the participant's disease activity that, in the opinion of the Investigator, required treatment intensification beyond supportive therapy which could include restarting the study drug.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, at end of study visit (Week 104), at early withdrawal (up to 104 weeks)Population: ITT population. Number Analyzed = participants who were evaluable for specified category.
The PGA of disease activity was assessed using a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equaled 0 mm, and was described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equaled 100 mm, and was described as "maximum disease activity" (maximum arthritis disease activity). A negative change from baseline indicated improvement. Participants who completed the study, or discontinued the study as per sponsor discretion due to marketing authorization approval, were included in End of Study Visit which was Week 104. Participants who withdrew from the study for the reason other than sponsor discretion due to marketing authorization approval, were included in Early Withdrawal Visit. Participants with "Unspecified" reason of discontinuation were excluded for change from baseline analysis.
Outcome measures
| Measure |
Tocilizumab
n=38 Participants
Participants received tocilizumab 8 mg/kg IV infusion q4w up to 104 weeks.
|
|---|---|
|
Change From Baseline in Physician's Global Assessment (PGA) of Disease Activity Using Visual Analog Scale (VAS)
Baseline
|
32.1 mm
Standard Deviation 24.60
|
|
Change From Baseline in Physician's Global Assessment (PGA) of Disease Activity Using Visual Analog Scale (VAS)
Week 12
|
-15.1 mm
Standard Deviation 21.57
|
|
Change From Baseline in Physician's Global Assessment (PGA) of Disease Activity Using Visual Analog Scale (VAS)
Week 24
|
-16.0 mm
Standard Deviation 19.05
|
|
Change From Baseline in Physician's Global Assessment (PGA) of Disease Activity Using Visual Analog Scale (VAS)
Week 36
|
-17.3 mm
Standard Deviation 19.37
|
|
Change From Baseline in Physician's Global Assessment (PGA) of Disease Activity Using Visual Analog Scale (VAS)
Week 48
|
-18.0 mm
Standard Deviation 20.06
|
|
Change From Baseline in Physician's Global Assessment (PGA) of Disease Activity Using Visual Analog Scale (VAS)
Week 56
|
-19.0 mm
Standard Deviation 20.60
|
|
Change From Baseline in Physician's Global Assessment (PGA) of Disease Activity Using Visual Analog Scale (VAS)
Week 68
|
-20.6 mm
Standard Deviation 22.13
|
|
Change From Baseline in Physician's Global Assessment (PGA) of Disease Activity Using Visual Analog Scale (VAS)
Week 80
|
-19.2 mm
Standard Deviation 19.01
|
|
Change From Baseline in Physician's Global Assessment (PGA) of Disease Activity Using Visual Analog Scale (VAS)
Week 92
|
-21.2 mm
Standard Deviation 17.50
|
|
Change From Baseline in Physician's Global Assessment (PGA) of Disease Activity Using Visual Analog Scale (VAS)
End of Study
|
-22.2 mm
Standard Deviation 20.92
|
|
Change From Baseline in Physician's Global Assessment (PGA) of Disease Activity Using Visual Analog Scale (VAS)
Early Withdrawal
|
-2.9 mm
Standard Deviation 22.71
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, at end of study visit (Week 104), at early withdrawal (up to 104 weeks)Population: ITT population. Number Analyzed = participants who were evaluable for specified category.
The PtGA of disease activity was assessed using a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equaled 0 mm, and was described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equaled 100 mm, and was described as "maximum disease activity" (maximum arthritis disease activity). A negative change from baseline indicated improvement. Participants who completed the study, or discontinued the study as per sponsor discretion due to marketing authorization approval, were included in End of Study Visit which was Week 104. Participants who withdrew from the study for the reason other than sponsor discretion due to marketing authorization approval, were included in Early Withdrawal Visit. Participants with "Unspecified" reason of discontinuation were excluded for change from baseline analysis.
Outcome measures
| Measure |
Tocilizumab
n=38 Participants
Participants received tocilizumab 8 mg/kg IV infusion q4w up to 104 weeks.
|
|---|---|
|
Change From Baseline in PtGA of Disease Activity Using VAS
Baseline
|
34.9 mm
Standard Deviation 27.33
|
|
Change From Baseline in PtGA of Disease Activity Using VAS
Week 12
|
-10.1 mm
Standard Deviation 21.63
|
|
Change From Baseline in PtGA of Disease Activity Using VAS
Week 24
|
-6.4 mm
Standard Deviation 20.57
|
|
Change From Baseline in PtGA of Disease Activity Using VAS
Week 36
|
-11.4 mm
Standard Deviation 20.14
|
|
Change From Baseline in PtGA of Disease Activity Using VAS
Week 48
|
-9.1 mm
Standard Deviation 21.24
|
|
Change From Baseline in PtGA of Disease Activity Using VAS
Week 56
|
-8.5 mm
Standard Deviation 19.14
|
|
Change From Baseline in PtGA of Disease Activity Using VAS
Week 68
|
-11.0 mm
Standard Deviation 21.54
|
|
Change From Baseline in PtGA of Disease Activity Using VAS
Week 80
|
-16.0 mm
Standard Deviation 24.10
|
|
Change From Baseline in PtGA of Disease Activity Using VAS
Week 92
|
-12.8 mm
Standard Deviation 12.40
|
|
Change From Baseline in PtGA of Disease Activity Using VAS
End of Study
|
-16.4 mm
Standard Deviation 22.13
|
|
Change From Baseline in PtGA of Disease Activity Using VAS
Early Withdrawal
|
5.4 mm
Standard Deviation 34.88
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, at end of study visit (Week 104), at early withdrawal (up to 104 weeks)Population: ITT population. Number Analyzed = participants who were evaluable for specified category.
Severity of pain was evaluated by a VAS. Participants marked on a 100 mm horizontal VAS the severity of pain that they had experienced because of their RA, ranging from 0 mm (no pain) to 100 mm (unbearable pain). Participants who completed the study, or discontinued the study as per sponsor discretion due to marketing authorization approval, were included in End of Study Visit which was Week 104. Participants who withdrew from the study for the reason other than sponsor discretion due to marketing authorization approval, were included in Early Withdrawal Visit. Participants with "Unspecified" reason of discontinuation were excluded for change from baseline analysis.
Outcome measures
| Measure |
Tocilizumab
n=38 Participants
Participants received tocilizumab 8 mg/kg IV infusion q4w up to 104 weeks.
|
|---|---|
|
Change From Baseline in Participant Assessment of Pain Using VAS
Baseline
|
35.0 mm
Standard Deviation 26.48
|
|
Change From Baseline in Participant Assessment of Pain Using VAS
Week 12
|
-11.6 mm
Standard Deviation 20.80
|
|
Change From Baseline in Participant Assessment of Pain Using VAS
Week 24
|
-8.4 mm
Standard Deviation 19.74
|
|
Change From Baseline in Participant Assessment of Pain Using VAS
Week 36
|
-12.7 mm
Standard Deviation 19.05
|
|
Change From Baseline in Participant Assessment of Pain Using VAS
Week 48
|
-10.9 mm
Standard Deviation 19.96
|
|
Change From Baseline in Participant Assessment of Pain Using VAS
Week 56
|
-9.9 mm
Standard Deviation 19.71
|
|
Change From Baseline in Participant Assessment of Pain Using VAS
Week 68
|
-11.7 mm
Standard Deviation 20.16
|
|
Change From Baseline in Participant Assessment of Pain Using VAS
Week 80
|
-15.3 mm
Standard Deviation 22.22
|
|
Change From Baseline in Participant Assessment of Pain Using VAS
Week 92
|
-10.9 mm
Standard Deviation 13.59
|
|
Change From Baseline in Participant Assessment of Pain Using VAS
End of Study
|
-17.2 mm
Standard Deviation 20.13
|
|
Change From Baseline in Participant Assessment of Pain Using VAS
Early Withdrawal
|
-0.7 mm
Standard Deviation 32.62
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, at end of study visit (Week 104), at early withdrawal (up to 104 weeks)Population: ITT population. Number Analyzed = participants who were evaluable for specified category.
The HAQ-DI was a participant self-reported questionnaire for assessing the extent of a participant's functional ability. It consisted of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question had 4 response options, ranging from 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The HAQ-DI scale was an average of all the scores from all questions and ranged from 0 to 3, where higher scores represented higher disease activity. Participants who completed the study, or discontinued the study as per sponsor discretion due to marketing authorization approval, were included in End of Study Visit which was Week 104. Participants who withdrew from study for reason other than sponsor discretion due to marketing authorization approval, were included in Early Withdrawal Visit. Participants with "Unspecified" reason of discontinuation were excluded for change from baseline analysis.
Outcome measures
| Measure |
Tocilizumab
n=38 Participants
Participants received tocilizumab 8 mg/kg IV infusion q4w up to 104 weeks.
|
|---|---|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Baseline
|
0.871 units on a scale
Standard Deviation 0.5981
|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Week 12
|
-0.169 units on a scale
Standard Deviation 0.3255
|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Week 24
|
-0.163 units on a scale
Standard Deviation 0.4301
|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Week 36
|
-0.208 units on a scale
Standard Deviation 0.4965
|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Week 48
|
-0.106 units on a scale
Standard Deviation 0.5001
|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Week 56
|
-0.185 units on a scale
Standard Deviation 0.5024
|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Week 68
|
-0.076 units on a scale
Standard Deviation 0.4154
|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Week 80
|
-0.152 units on a scale
Standard Deviation 0.4095
|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Week 92
|
-0.271 units on a scale
Standard Deviation 0.3100
|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
End of Study
|
-0.239 units on a scale
Standard Deviation 0.5698
|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Early Withdrawal
|
0.019 units on a scale
Standard Deviation 0.2230
|
Adverse Events
Tocilizumab
Serious adverse events
| Measure |
Tocilizumab
n=38 participants at risk
Participants received tocilizumab 8 mg/kg IV infusion q4w up to 104 weeks.
|
|---|---|
|
Infections and infestations
Vestibular neuronitis
|
2.6%
1/38 • Baseline up to 112 weeks
ITT population.
|
|
Cardiac disorders
Myocardial ischemia
|
2.6%
1/38 • Baseline up to 112 weeks
ITT population.
|
|
Nervous system disorders
Speech disorder
|
2.6%
1/38 • Baseline up to 112 weeks
ITT population.
|
|
Ear and labyrinth disorders
Vertigo
|
2.6%
1/38 • Baseline up to 112 weeks
ITT population.
|
Other adverse events
| Measure |
Tocilizumab
n=38 participants at risk
Participants received tocilizumab 8 mg/kg IV infusion q4w up to 104 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.3%
2/38 • Baseline up to 112 weeks
ITT population.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
2/38 • Baseline up to 112 weeks
ITT population.
|
|
Infections and infestations
Upper respiratory tract infection
|
13.2%
5/38 • Baseline up to 112 weeks
ITT population.
|
|
Infections and infestations
Nasopharyngitis
|
10.5%
4/38 • Baseline up to 112 weeks
ITT population.
|
|
Infections and infestations
Bronchitis
|
7.9%
3/38 • Baseline up to 112 weeks
ITT population.
|
|
Infections and infestations
Pharyngitis
|
5.3%
2/38 • Baseline up to 112 weeks
ITT population.
|
|
Investigations
Alanine aminotransferase increased
|
28.9%
11/38 • Baseline up to 112 weeks
ITT population.
|
|
Investigations
Hepatic enzyme increased
|
7.9%
3/38 • Baseline up to 112 weeks
ITT population.
|
|
Investigations
Aspartate aminotransferase increased
|
5.3%
2/38 • Baseline up to 112 weeks
ITT population.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
15.8%
6/38 • Baseline up to 112 weeks
ITT population.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
5.3%
2/38 • Baseline up to 112 weeks
ITT population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
2/38 • Baseline up to 112 weeks
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