Trial Outcomes & Findings for A Long Term Extension Study of WA19926 (NCT01007435) of Tocilizumab (RoActemra/Actemra) in Participants With Early, Moderate to Severe Rheumatoid Arthritis (RA) (NCT NCT01668966)
NCT ID: NCT01668966
Last Updated: 2019-05-13
Results Overview
An adverse event (AE) is any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease temporarily associated with use of study drug, regardless of its relation to study drug. A TEAE is an AE that occurs only once treatment has started. An SAE can be a) fatal, b) life-threatening, c) requires/prolongs hospitalization, d) results in persistent/significant incapacity/disability, e) results in congenital anomaly/birth defect or f) is considered as a significant medical event by the investigator.
COMPLETED
PHASE3
23 participants
Baseline up to approximately 104 weeks
2019-05-13
Participant Flow
Participant milestones
| Measure |
Tocilizumab
Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenous (IV) every 4 weeks for up to 104 weeks.
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
Treated
|
21
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Tocilizumab
Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenous (IV) every 4 weeks for up to 104 weeks.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
Not treated
|
2
|
Baseline Characteristics
A Long Term Extension Study of WA19926 (NCT01007435) of Tocilizumab (RoActemra/Actemra) in Participants With Early, Moderate to Severe Rheumatoid Arthritis (RA)
Baseline characteristics by cohort
| Measure |
Tocilizumab
n=21 Participants
Participants received tocilizumab 8 mg/kg IV every 4 weeks for up to 104 weeks.
|
|---|---|
|
Age, Continuous
|
52.5 years
STANDARD_DEVIATION 9.18 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to approximately 104 weeksPopulation: ITT population
An adverse event (AE) is any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease temporarily associated with use of study drug, regardless of its relation to study drug. A TEAE is an AE that occurs only once treatment has started. An SAE can be a) fatal, b) life-threatening, c) requires/prolongs hospitalization, d) results in persistent/significant incapacity/disability, e) results in congenital anomaly/birth defect or f) is considered as a significant medical event by the investigator.
Outcome measures
| Measure |
Tocilizumab
n=21 Participants
Participants received tocilizumab 8 mg/kg IV every 4 weeks for up to 104 weeks.
|
|---|---|
|
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs
|
95.2 percentage of participants
|
|
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
9.5 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to approximately 104 weeksPopulation: ITT population
An AE is any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease temporarily associated with use of study drug, regardless of its relation to study drug. A TEAE is an AE that occurs only once treatment has started. Nine categories of AE of special interest are identified for tocilizumab which includes a) serious/medically significant infections, b) myocardial infarction/acute coronary syndrome, c) gastrointestinal perforations, d) malignancies, e) anaphylaxis/hypersensitivity reactions, f) demyelinating disorders, g) stroke, h) serious and/or medically significant bleeding events, and i) serious/medically significant hepatic events. Data reported is an average of the nine categories.
Outcome measures
| Measure |
Tocilizumab
n=21 Participants
Participants received tocilizumab 8 mg/kg IV every 4 weeks for up to 104 weeks.
|
|---|---|
|
Percentage of Participants With TEAEs of Special Interest
|
95.2 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to approximately 104 weeksPopulation: ITT population
An AE is any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease temporarily associated with use of study drug, regardless of its relation to study drug. A TEAE is an AE that occurs only once treatment has started.
Outcome measures
| Measure |
Tocilizumab
n=21 Participants
Participants received tocilizumab 8 mg/kg IV every 4 weeks for up to 104 weeks.
|
|---|---|
|
Percentage of Participants With TEAEs Leading to Change in Dose or Study Drug Discontinuation
TEAEs leading to study drug discontinuation
|
4.8 percentage of participants
|
|
Percentage of Participants With TEAEs Leading to Change in Dose or Study Drug Discontinuation
TEAEs leading to dose modification
|
28.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)Population: ITT population. Here, 'n' represents the number of participants available for assessment at a given time point.
The DAS28-ESR is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response (APR) determined as erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hr), and general health (GH) (patient global assessment of disease activity \[PGA\] using visual analog scale \[VAS\], range 1-100 millimeters \[mm\]) (higher scores indicate higher disease activity). DAS28-ESR is calculated according to the following formula: DAS28-ESR equals (=) \[0.56 multiplied by (\*) the square root (√) of TJC\] plus (+) \[0.28 \* √ of SJC\] + (0.70 \* the natural logarithm \[ln\] ESR in mm/h) + (0.014\*GH in mm VAS). DAS28-ESR scale is transformed and ranges from 0 to 10. A negative CFB indicated improvement.
Outcome measures
| Measure |
Tocilizumab
n=21 Participants
Participants received tocilizumab 8 mg/kg IV every 4 weeks for up to 104 weeks.
|
|---|---|
|
Change From Baseline (CFB) in Disease Activity Score 28 Using Erythrocyte Sedimentation Rate (DAS28-ESR) at Specified Time Points
CFB at Week 92 (n=18)
|
-0.2 units on a scale
Standard Deviation 1.5
|
|
Change From Baseline (CFB) in Disease Activity Score 28 Using Erythrocyte Sedimentation Rate (DAS28-ESR) at Specified Time Points
Baseline (n=21)
|
2.4 units on a scale
Standard Deviation 1.76
|
|
Change From Baseline (CFB) in Disease Activity Score 28 Using Erythrocyte Sedimentation Rate (DAS28-ESR) at Specified Time Points
CFB at Week 12 (n=19)
|
-0.6 units on a scale
Standard Deviation 1.6
|
|
Change From Baseline (CFB) in Disease Activity Score 28 Using Erythrocyte Sedimentation Rate (DAS28-ESR) at Specified Time Points
CFB at Week 24 (n=21)
|
-0.6 units on a scale
Standard Deviation 1.7
|
|
Change From Baseline (CFB) in Disease Activity Score 28 Using Erythrocyte Sedimentation Rate (DAS28-ESR) at Specified Time Points
CFB at Week 36 (n=19)
|
-0.5 units on a scale
Standard Deviation 1.3
|
|
Change From Baseline (CFB) in Disease Activity Score 28 Using Erythrocyte Sedimentation Rate (DAS28-ESR) at Specified Time Points
CFB at Week 48 (n=20)
|
-0.6 units on a scale
Standard Deviation 1.9
|
|
Change From Baseline (CFB) in Disease Activity Score 28 Using Erythrocyte Sedimentation Rate (DAS28-ESR) at Specified Time Points
CFB at Week 56 (n=19)
|
-0.5 units on a scale
Standard Deviation 1.7
|
|
Change From Baseline (CFB) in Disease Activity Score 28 Using Erythrocyte Sedimentation Rate (DAS28-ESR) at Specified Time Points
CFB at Week 68 (n=20)
|
-0.4 units on a scale
Standard Deviation 2.0
|
|
Change From Baseline (CFB) in Disease Activity Score 28 Using Erythrocyte Sedimentation Rate (DAS28-ESR) at Specified Time Points
CFB at Week 80 (n=21)
|
0.3 units on a scale
Standard Deviation 1.9
|
|
Change From Baseline (CFB) in Disease Activity Score 28 Using Erythrocyte Sedimentation Rate (DAS28-ESR) at Specified Time Points
CFB at Week 104 (n=16)
|
-0.7 units on a scale
Standard Deviation 1.3
|
|
Change From Baseline (CFB) in Disease Activity Score 28 Using Erythrocyte Sedimentation Rate (DAS28-ESR) at Specified Time Points
CFB at Early withdrawal (n=1)
|
-0.3 units on a scale
Standard Deviation NA
Standard deviation (SD) is not applicable for a single participant.
|
|
Change From Baseline (CFB) in Disease Activity Score 28 Using Erythrocyte Sedimentation Rate (DAS28-ESR) at Specified Time Points
CFB at Follow-up visit 1 (n=16)
|
0.6 units on a scale
Standard Deviation 2.1
|
|
Change From Baseline (CFB) in Disease Activity Score 28 Using Erythrocyte Sedimentation Rate (DAS28-ESR) at Specified Time Points
CFB at Follow-up visit 2 (n=14)
|
1.7 units on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)Population: ITT population. Here, 'n' represents the number of participants available for assessment at a given time point.
The SDAI is a combined index for measuring disease activity. SDAI is the sum of TJC and SJC, both scored 0-28 (higher scores indicate higher disease activity), physician global assessment (PhGA) and PGA of disease activity, both scored 0 to 10 centimeters (cm) as assessed by VAS, and C-reactive protein level (CRP) in milligrams per deciliter (mg/dL) where normal is less than (\<) 1 mg/dL. SDAI is calculated according to the following formula: SDAI = TJC + SJC + PhGA + PGA + CRP. SDAI ranges from 0 to 86. A negative CFB indicated improvement.
Outcome measures
| Measure |
Tocilizumab
n=21 Participants
Participants received tocilizumab 8 mg/kg IV every 4 weeks for up to 104 weeks.
|
|---|---|
|
CFB in Simplified Disease Activity Index (SDAI) Score at Specified Time Points
Baseline (n=21)
|
9.5 units on a scale
Standard Deviation 11.84
|
|
CFB in Simplified Disease Activity Index (SDAI) Score at Specified Time Points
CFB at Week 56 (n=20)
|
-3.2 units on a scale
Standard Deviation 11.09
|
|
CFB in Simplified Disease Activity Index (SDAI) Score at Specified Time Points
CFB at Early withdrawal (n=1)
|
-0.3 units on a scale
Standard Deviation NA
SD is not applicable for a single participant.
|
|
CFB in Simplified Disease Activity Index (SDAI) Score at Specified Time Points
CFB at Follow-up visit 1 (n=19)
|
2.0 units on a scale
Standard Deviation 12.36
|
|
CFB in Simplified Disease Activity Index (SDAI) Score at Specified Time Points
CFB at Week 12 (n=20)
|
-2.4 units on a scale
Standard Deviation 7.75
|
|
CFB in Simplified Disease Activity Index (SDAI) Score at Specified Time Points
CFB at Week 24 (n=21)
|
-2.7 units on a scale
Standard Deviation 11.46
|
|
CFB in Simplified Disease Activity Index (SDAI) Score at Specified Time Points
CFB at Week 36 (n=20)
|
-2.8 units on a scale
Standard Deviation 9.85
|
|
CFB in Simplified Disease Activity Index (SDAI) Score at Specified Time Points
CFB at Week 48 (n=20)
|
-3.0 units on a scale
Standard Deviation 12.71
|
|
CFB in Simplified Disease Activity Index (SDAI) Score at Specified Time Points
CFB at Week 68 (n=20)
|
-0.6 units on a scale
Standard Deviation 18.1
|
|
CFB in Simplified Disease Activity Index (SDAI) Score at Specified Time Points
CFB at Week 80 (n=21)
|
0.9 units on a scale
Standard Deviation 13.92
|
|
CFB in Simplified Disease Activity Index (SDAI) Score at Specified Time Points
CFB at Week 92 (n=19)
|
-1.1 units on a scale
Standard Deviation 9.47
|
|
CFB in Simplified Disease Activity Index (SDAI) Score at Specified Time Points
CFB at Week 104 (n=19)
|
-1.4 units on a scale
Standard Deviation 7.6
|
|
CFB in Simplified Disease Activity Index (SDAI) Score at Specified Time Points
CFB at Follow-up visit 2 (n=14)
|
9.5 units on a scale
Standard Deviation 16.71
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)Population: ITT population. Here, 'n' represents the number of participants available for assessment at a given time point.
For SJC, a total of 66 joints are assessed. The presence of a swollen joint is scored as 1 and absence as 0. Total score is calculated by adding the scores, which ranges from 0 (best possible score or no swollen joint) to 66 (worse possible score or all swollen joints). Lower scores indicated no swollen joint and higher scores indicated worsening swollen joints.
Outcome measures
| Measure |
Tocilizumab
n=21 Participants
Participants received tocilizumab 8 mg/kg IV every 4 weeks for up to 104 weeks.
|
|---|---|
|
CFB in Swollen Joint Count (SJC) at Specified Time Points
CFB at Week 36 (n=6)
|
-1.5 swollen joints
Standard Deviation 2.81
|
|
CFB in Swollen Joint Count (SJC) at Specified Time Points
CFB at Week 48 (n=7)
|
-0.9 swollen joints
Standard Deviation 3.48
|
|
CFB in Swollen Joint Count (SJC) at Specified Time Points
Baseline (n=21)
|
0.8 swollen joints
Standard Deviation 1.7
|
|
CFB in Swollen Joint Count (SJC) at Specified Time Points
CFB at Week 12 (n=6)
|
-1.3 swollen joints
Standard Deviation 1.37
|
|
CFB in Swollen Joint Count (SJC) at Specified Time Points
CFB at Week 24 (n=7)
|
-1.6 swollen joints
Standard Deviation 1.81
|
|
CFB in Swollen Joint Count (SJC) at Specified Time Points
CFB at Week 56 (n=6)
|
-1.8 swollen joints
Standard Deviation 2.56
|
|
CFB in Swollen Joint Count (SJC) at Specified Time Points
CFB at Week 68 (n=7)
|
-2.0 swollen joints
Standard Deviation 2.38
|
|
CFB in Swollen Joint Count (SJC) at Specified Time Points
CFB at Week 80 (n=7)
|
1.1 swollen joints
Standard Deviation 5.49
|
|
CFB in Swollen Joint Count (SJC) at Specified Time Points
CFB at Week 92 (n=6)
|
1.7 swollen joints
Standard Deviation 5.32
|
|
CFB in Swollen Joint Count (SJC) at Specified Time Points
CFB at Week 104 (n=6)
|
1.2 swollen joints
Standard Deviation 3.82
|
|
CFB in Swollen Joint Count (SJC) at Specified Time Points
CFB at Follow-up visit 1 (n=6)
|
-1.3 swollen joints
Standard Deviation 1.37
|
|
CFB in Swollen Joint Count (SJC) at Specified Time Points
CFB at Follow-up visit 2 (n=3)
|
-1.0 swollen joints
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)Population: ITT population. Here, 'n' represents the number of participants available for assessment at a given time point.
The number of tender joints is recorded on the joint assessment form, no tenderness = 0, tenderness = 1, for 68 joints and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68.
Outcome measures
| Measure |
Tocilizumab
n=21 Participants
Participants received tocilizumab 8 mg/kg IV every 4 weeks for up to 104 weeks.
|
|---|---|
|
CFB in Tender Joint Count (TJC) at Specified Time Points
Baseline (n=21)
|
5.8 tender joints
Standard Deviation 8.57
|
|
CFB in Tender Joint Count (TJC) at Specified Time Points
CFB at Week 36 (n=14)
|
-5.4 tender joints
Standard Deviation 8.35
|
|
CFB in Tender Joint Count (TJC) at Specified Time Points
CFB at Week 48 (n=14)
|
-5.9 tender joints
Standard Deviation 8.4
|
|
CFB in Tender Joint Count (TJC) at Specified Time Points
CFB at Week 12 (n=13)
|
-3.1 tender joints
Standard Deviation 8.95
|
|
CFB in Tender Joint Count (TJC) at Specified Time Points
CFB at Week 24 (n=14)
|
-4.8 tender joints
Standard Deviation 10.39
|
|
CFB in Tender Joint Count (TJC) at Specified Time Points
CFB at Week 56 (n=14)
|
-6.0 tender joints
Standard Deviation 8.41
|
|
CFB in Tender Joint Count (TJC) at Specified Time Points
CFB at Week 68 (n=13)
|
-2.3 tender joints
Standard Deviation 16.51
|
|
CFB in Tender Joint Count (TJC) at Specified Time Points
CFB at Week 80 (n=14)
|
-3.5 tender joints
Standard Deviation 11.65
|
|
CFB in Tender Joint Count (TJC) at Specified Time Points
CFB at Week 92 (n=12)
|
-3.6 tender joints
Standard Deviation 12.42
|
|
CFB in Tender Joint Count (TJC) at Specified Time Points
CFB at Week 104 (n=12)
|
-4.3 tender joints
Standard Deviation 9.98
|
|
CFB in Tender Joint Count (TJC) at Specified Time Points
CFB at Early withdrawal (n=1)
|
0.0 tender joints
Standard Deviation NA
Standard deviation (SD) is not applicable for a single participant.
|
|
CFB in Tender Joint Count (TJC) at Specified Time Points
CFB at Follow-up visit 1 (n=12)
|
0.0 tender joints
Standard Deviation 0.0
|
|
CFB in Tender Joint Count (TJC) at Specified Time Points
CFB at Follow-up visit 2 (n=9)
|
2.4 tender joints
Standard Deviation 8.85
|
SECONDARY outcome
Timeframe: Baseline up to approximately 104 weeksPopulation: ITT population
Remission: DAS28-ESR score \<2.6 and SDAI score \</=3.3. DAS28-ESR index included SJC and TJC, both scored 0-28, as well as APR determined as ESR in mm/hr, and GH (ranges 1-100 mm; higher scores=higher disease activity). DAS28=(0.56\*√TJC)+(0.28\*√SJC) +(0.70\*ln ESR) +(0.014\*GH). DAS28-ESR scale is transformed and ranges from 0 to 10. Negative CFB indicated improvement. DAS28 \>2.6 (clinical remission); DAS28 2.6 to 3.2 (low disease activity); DAS28 \>3.2 to 5.1 = moderate to high disease activity. SDAI is sum of TJC and SJC (both scored 0-28), PhGA and PGA of disease activity (both scored 0 to 10 cm as assessed by VAS, higher scores=higher disease activity), and CRP in mg/dL where normal is \<1 mg/dL. SDAI=TJC + SJC + PhGA + PGA + CRP. SDAI ranged from 0 to 86. A negative CFB indicated improvement. SDAI \<=3.3 (clinical remission), \>3.4 to 11 (low disease activity) \>11 to 26 (moderate disease activity), and \>26 = (high/severe disease activity).
Outcome measures
| Measure |
Tocilizumab
n=21 Participants
Participants received tocilizumab 8 mg/kg IV every 4 weeks for up to 104 weeks.
|
|---|---|
|
Percentage of Participants Reaching Clinical Remission (DAS28-ESR Score Less Than [<] 2.6 and/or SDAI Score Less Than or Equal to [</=] 3.3) Among Participants for Whom Tocilizumab Treatment Was Discontinued
Percentage of participants achieved SDAI</=3.3
|
100 percentage of participants
|
|
Percentage of Participants Reaching Clinical Remission (DAS28-ESR Score Less Than [<] 2.6 and/or SDAI Score Less Than or Equal to [</=] 3.3) Among Participants for Whom Tocilizumab Treatment Was Discontinued
Percentage of participants achieved DAS28-ESR <2.6
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to approximately 104 weeksPopulation: ITT population
RA crisis is any worsening of participant disease acitivity that, in the opinion of the investigator, required intensified treatment other than supportive therapy, and may have included restart of the treatment with the study drug. Time to RA crisis is defined as the period of remission without drug until the RA crisis documentation.
Outcome measures
| Measure |
Tocilizumab
n=21 Participants
Participants received tocilizumab 8 mg/kg IV every 4 weeks for up to 104 weeks.
|
|---|---|
|
Time to RA Crisis Among Participants Who Discontinued After Clinical Remission
|
135.3 days
Standard Deviation 53.73
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)Population: ITT population. Here, 'n' represents the number of participants available for assessment at a given time point.
PGA of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative CFB indicated improvement.
Outcome measures
| Measure |
Tocilizumab
n=21 Participants
Participants received tocilizumab 8 mg/kg IV every 4 weeks for up to 104 weeks.
|
|---|---|
|
CFB in PGA of Disease Activity Using VAS Score at Specified Time Points
CFB at Week 36 (n=20)
|
2.0 mm
Standard Deviation 18.5
|
|
CFB in PGA of Disease Activity Using VAS Score at Specified Time Points
CFB at Week 48 (n=20)
|
0.4 mm
Standard Deviation 25.8
|
|
CFB in PGA of Disease Activity Using VAS Score at Specified Time Points
Baseline (n=21)
|
26.5 mm
Standard Deviation 19.90
|
|
CFB in PGA of Disease Activity Using VAS Score at Specified Time Points
CFB at Week 12 (n=20)
|
-0.3 mm
Standard Deviation 16.1
|
|
CFB in PGA of Disease Activity Using VAS Score at Specified Time Points
CFB at Week 24 (n=21)
|
2.5 mm
Standard Deviation 23.2
|
|
CFB in PGA of Disease Activity Using VAS Score at Specified Time Points
CFB at Week 56 (n=20)
|
-0.5 mm
Standard Deviation 22.1
|
|
CFB in PGA of Disease Activity Using VAS Score at Specified Time Points
CFB at Week 68 (n=20)
|
1.3 mm
Standard Deviation 27.0
|
|
CFB in PGA of Disease Activity Using VAS Score at Specified Time Points
CFB at Week 80 (n=21)
|
6.2 mm
Standard Deviation 27.5
|
|
CFB in PGA of Disease Activity Using VAS Score at Specified Time Points
CFB at Week 92 (n=19)
|
3.5 mm
Standard Deviation 21.6
|
|
CFB in PGA of Disease Activity Using VAS Score at Specified Time Points
CFB at Week 104 (n=19)
|
5.1 mm
Standard Deviation 18.4
|
|
CFB in PGA of Disease Activity Using VAS Score at Specified Time Points
CFB at Early withdrawal (n=1)
|
6.0 mm
Standard Deviation NA
SD is not applicable for a single participant.
|
|
CFB in PGA of Disease Activity Using VAS Score at Specified Time Points
CFB at Follow-up visit 1 (n=17)
|
4.9 mm
Standard Deviation 22.3
|
|
CFB in PGA of Disease Activity Using VAS Score at Specified Time Points
CFB at Follow-up visit 2 (n=14)
|
11.0 mm
Standard Deviation 29.4
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)Population: ITT population. Here, 'n' represents the number of participants available for assessment at a given time point.
PGA of pain is assessed on a 0 to 100 mm horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as "no pain" and the right-hand extreme equals 100 mm, and is described as "unbearable pain". A negative change indicated improvement.
Outcome measures
| Measure |
Tocilizumab
n=21 Participants
Participants received tocilizumab 8 mg/kg IV every 4 weeks for up to 104 weeks.
|
|---|---|
|
CFB in PGA of Pain Using VAS Score at Specified Time Points
CFB at Week 68 (n=20)
|
3.7 mm
Standard Deviation 26.4
|
|
CFB in PGA of Pain Using VAS Score at Specified Time Points
CFB at Week 80 (n=21)
|
7.5 mm
Standard Deviation 28.9
|
|
CFB in PGA of Pain Using VAS Score at Specified Time Points
CFB at Week 92 (n=19)
|
2.8 mm
Standard Deviation 23.4
|
|
CFB in PGA of Pain Using VAS Score at Specified Time Points
Baseline (n=21)
|
22.3 mm
Standard Deviation 21.76
|
|
CFB in PGA of Pain Using VAS Score at Specified Time Points
CFB at Week 12 (n=20)
|
2.5 mm
Standard Deviation 14.1
|
|
CFB in PGA of Pain Using VAS Score at Specified Time Points
CFB at Week 24 (n=21)
|
5.0 mm
Standard Deviation 27.7
|
|
CFB in PGA of Pain Using VAS Score at Specified Time Points
CFB at Week 36 (n=20)
|
3.6 mm
Standard Deviation 18.5
|
|
CFB in PGA of Pain Using VAS Score at Specified Time Points
CFB at Week 48 (n=20)
|
0.6 mm
Standard Deviation 26.4
|
|
CFB in PGA of Pain Using VAS Score at Specified Time Points
CFB at Week 56 (n=20)
|
1.0 mm
Standard Deviation 20.0
|
|
CFB in PGA of Pain Using VAS Score at Specified Time Points
CFB at Week 104 (n=19)
|
5.8 mm
Standard Deviation 19.8
|
|
CFB in PGA of Pain Using VAS Score at Specified Time Points
CFB at Early withdrawal (n=1)
|
8.0 mm
Standard Deviation NA
SD is not applicable for a single participant.
|
|
CFB in PGA of Pain Using VAS Score at Specified Time Points
CFB at Follow-up visit 1 (n=17)
|
7.8 mm
Standard Deviation 24.4
|
|
CFB in PGA of Pain Using VAS Score at Specified Time Points
CFB at Follow-up visit 2 (n=14)
|
13.6 mm
Standard Deviation 29.0
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)Population: ITT population. Here, 'n' represents the number of participants available for assessment at a given time point.
PhGA of disease activity is assessed on a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm as "maximum disease activity" (maximum arthritis disease activity).
Outcome measures
| Measure |
Tocilizumab
n=21 Participants
Participants received tocilizumab 8 mg/kg IV every 4 weeks for up to 104 weeks.
|
|---|---|
|
CFB in PhGA of Disease Activity Using VAS Score at Specified Time Points
CFB at Week 48 (n=20)
|
0.8 mm
Standard Deviation 13.1
|
|
CFB in PhGA of Disease Activity Using VAS Score at Specified Time Points
CFB at Week 56 (n=20)
|
-2.2 mm
Standard Deviation 9.6
|
|
CFB in PhGA of Disease Activity Using VAS Score at Specified Time Points
CFB at Week 68 (n=20)
|
1.5 mm
Standard Deviation 18.1
|
|
CFB in PhGA of Disease Activity Using VAS Score at Specified Time Points
CFB at Week 80 (n=21)
|
7.6 mm
Standard Deviation 21.3
|
|
CFB in PhGA of Disease Activity Using VAS Score at Specified Time Points
Baseline (n=21)
|
7.9 mm
Standard Deviation 11.13
|
|
CFB in PhGA of Disease Activity Using VAS Score at Specified Time Points
CFB at Week 12 (n=20)
|
-1.0 mm
Standard Deviation 7.3
|
|
CFB in PhGA of Disease Activity Using VAS Score at Specified Time Points
CFB at Week 24 (n=21)
|
-0.8 mm
Standard Deviation 7.7
|
|
CFB in PhGA of Disease Activity Using VAS Score at Specified Time Points
CFB at Week 36 (n=20)
|
-1.0 mm
Standard Deviation 8.3
|
|
CFB in PhGA of Disease Activity Using VAS Score at Specified Time Points
CFB at Week 92 (n=19)
|
4.1 mm
Standard Deviation 13.3
|
|
CFB in PhGA of Disease Activity Using VAS Score at Specified Time Points
CFB at Week 104 (n=19)
|
5.1 mm
Standard Deviation 12.2
|
|
CFB in PhGA of Disease Activity Using VAS Score at Specified Time Points
CFB at Early withdrawal (n=1)
|
-1.0 mm
Standard Deviation NA
SD is not applicable for a single participant.
|
|
CFB in PhGA of Disease Activity Using VAS Score at Specified Time Points
CFB at Follow-up visit 1 (n=19)
|
3.4 mm
Standard Deviation 9.0
|
|
CFB in PhGA of Disease Activity Using VAS Score at Specified Time Points
CFB at Follow-up visit 2 (n=14)
|
9.1 mm
Standard Deviation 17.3
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)Population: ITT population. Here, 'n' represents the number of participants available for assessment at a given time point.
HAQ-DI is a self-reported participant questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. Total score for HAQ-DI is the sum of all questions and ranges from 0 = without any difficulty to 60 = unable to do. A negative CFB indicates improvement.
Outcome measures
| Measure |
Tocilizumab
n=21 Participants
Participants received tocilizumab 8 mg/kg IV every 4 weeks for up to 104 weeks.
|
|---|---|
|
CFB in Health Assessment Questionnaire-Disease Index (HAQ-DI) Score at Specified Time Points
CFB at Week 12 (n=20)
|
1.60 units on a scale
Standard Deviation 7.155
|
|
CFB in Health Assessment Questionnaire-Disease Index (HAQ-DI) Score at Specified Time Points
CFB at Week 24 (n=21)
|
-0.10 units on a scale
Standard Deviation 4.560
|
|
CFB in Health Assessment Questionnaire-Disease Index (HAQ-DI) Score at Specified Time Points
CFB at Week 56 (n=20)
|
-0.65 units on a scale
Standard Deviation 4.258
|
|
CFB in Health Assessment Questionnaire-Disease Index (HAQ-DI) Score at Specified Time Points
CFB at Week 68 (n=20)
|
-0.40 units on a scale
Standard Deviation 7.373
|
|
CFB in Health Assessment Questionnaire-Disease Index (HAQ-DI) Score at Specified Time Points
CFB at Week 80 (n=21)
|
2.57 units on a scale
Standard Deviation 10.03
|
|
CFB in Health Assessment Questionnaire-Disease Index (HAQ-DI) Score at Specified Time Points
CFB at Week 92 (n=19)
|
1.21 units on a scale
Standard Deviation 5.855
|
|
CFB in Health Assessment Questionnaire-Disease Index (HAQ-DI) Score at Specified Time Points
CFB at Week 104 (n=19)
|
0.21 units on a scale
Standard Deviation 5.473
|
|
CFB in Health Assessment Questionnaire-Disease Index (HAQ-DI) Score at Specified Time Points
CFB at Early withdrawal (n=1)
|
-1.00 units on a scale
Standard Deviation NA
SD is not applicable for a single participant.
|
|
CFB in Health Assessment Questionnaire-Disease Index (HAQ-DI) Score at Specified Time Points
CFB at Follow-up visit 1 (n=17)
|
0.94 units on a scale
Standard Deviation 5.226
|
|
CFB in Health Assessment Questionnaire-Disease Index (HAQ-DI) Score at Specified Time Points
CFB at Follow-up visit 2 (n=14)
|
3.64 units on a scale
Standard Deviation 6.344
|
|
CFB in Health Assessment Questionnaire-Disease Index (HAQ-DI) Score at Specified Time Points
Baseline (n=21)
|
4.38 units on a scale
Standard Deviation 5.463
|
|
CFB in Health Assessment Questionnaire-Disease Index (HAQ-DI) Score at Specified Time Points
CFB at Week 36 (n=20)
|
0.05 units on a scale
Standard Deviation 4.419
|
|
CFB in Health Assessment Questionnaire-Disease Index (HAQ-DI) Score at Specified Time Points
CFB at Week 48 (n=20)
|
-1.05 units on a scale
Standard Deviation 4.199
|
Adverse Events
Tocilizumab
Serious adverse events
| Measure |
Tocilizumab
n=21 participants at risk
Participants received tocilizumab 8 mg/kg IV every 4 weeks for up to 104 weeks.
|
|---|---|
|
Reproductive system and breast disorders
Vaginal bleeding
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumonia
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Cardiac disorders
Cardiac arrhythimia
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
Other adverse events
| Measure |
Tocilizumab
n=21 participants at risk
Participants received tocilizumab 8 mg/kg IV every 4 weeks for up to 104 weeks.
|
|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Cardiac disorders
Dizziness
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Cardiac disorders
Tachycardia
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Endocrine disorders
Diabetes mellitus
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Endocrine disorders
Menstruation irregular
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Eye disorders
Ulcerative keratitis
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Eye disorders
Conjunctivitis
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Eye disorders
Scleritis
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
General disorders
Impaired healing
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
General disorders
Drug intolerance
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Hepatobiliary disorders
Cholestasis
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Immune system disorders
Rheumatoid arthritis
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Infections and infestations
Vaginitis Bacterial
|
9.5%
2/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Infections and infestations
Cellulitis
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Infections and infestations
Labyrinthitis
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Infections and infestations
Upper respiratory tract infection
|
19.0%
4/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Infections and infestations
Nasopharyngitis
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Infections and infestations
Viraemia
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Infections and infestations
Urinary tract infection
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Injury, poisoning and procedural complications
Chest injury
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Investigations
Transaminases Increased
|
9.5%
2/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
23.8%
5/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Musculoskeletal and connective tissue disorders
Sciatica
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pyogenic Granuloma
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Nervous system disorders
Headache
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Renal and urinary disorders
Renal cyst
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
9.5%
2/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Reproductive system and breast disorders
Vaginitis Bacterial
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Reproductive system and breast disorders
Menorrhagia
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Sinusitis
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Cough
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.5%
2/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection
|
42.9%
9/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
9.5%
2/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
9.5%
2/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheobronchitis
|
14.3%
3/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Skin and subcutaneous tissue disorders
Blepharitis
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Vascular disorders
Hypertension
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
|
Vascular disorders
Mesenteric thrombosis
|
4.8%
1/21 • Baseline up to approximately 104 weeks
Only TEAEs were reported.
|
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