Trial Outcomes & Findings for A Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs or Anti-TNF (NCT NCT01326962)
NCT ID: NCT01326962
Last Updated: 2017-08-16
Results Overview
The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (erythrocyte sedimentation rate \[ESR\] in millimeters per hour \[mm/hr\]), and general health status (participant global assessment of disease activity using visual analog scale \[VAS\], range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.
COMPLETED
PHASE3
28 participants
Up to 1 year
2017-08-16
Participant Flow
The study was conducted at 3 centers ( 1 center was prematurely terminated) across the Kingdom of Saudi Arabia from 02 November 2011 to 12 May 2013.
Participant milestones
| Measure |
Tocilizumab
Participants received Tocilizumab 8 milligram per kilogram (mg/kg) intravenously (IV) every 4 weeks for a total of 6 infusions up to Week 20. A follow-up visit at Week 24 was planned, after which evaluation of responders was done. Good/moderate EULAR responders continued receiving Tocilizumab every 4 weeks, till 1 year treatment or commercial availability.
|
|---|---|
|
Overall Study
STARTED
|
28
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Tocilizumab
Participants received Tocilizumab 8 milligram per kilogram (mg/kg) intravenously (IV) every 4 weeks for a total of 6 infusions up to Week 20. A follow-up visit at Week 24 was planned, after which evaluation of responders was done. Good/moderate EULAR responders continued receiving Tocilizumab every 4 weeks, till 1 year treatment or commercial availability.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Other
|
2
|
Baseline Characteristics
A Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs or Anti-TNF
Baseline characteristics by cohort
| Measure |
Tocilizumab
n=28 Participants
Participants received Tocilizumab 8 milligram per kilogram (mg/kg) intravenously (IV) every 4 weeks for a total of 6 infusions up to Week 20. A follow-up visit at Week 24 was planned, after which evaluation of responders was done. Good/moderate EULAR responders continued receiving Tocilizumab every 4 weeks, till 1 year treatment or commercial availability.
|
|---|---|
|
Age, Continuous
|
45.1 years
STANDARD_DEVIATION 12.40 • n=93 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: The intent-to-treat population (ITT) consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' is equal to (=) number of participants analyzed at particular point of time.
The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (erythrocyte sedimentation rate \[ESR\] in millimeters per hour \[mm/hr\]), and general health status (participant global assessment of disease activity using visual analog scale \[VAS\], range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.
Outcome measures
| Measure |
Tocilizumab
n=28 Participants
Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
|
|---|---|
|
Disease Activity as Measured by Disease Activity Score 28 (DAS28)
Visit 9 (n= 21)
|
1.9 units on a scale
Interval 0.0 to 3.7
|
|
Disease Activity as Measured by Disease Activity Score 28 (DAS28)
Visit 13 (n= 13)
|
2.1 units on a scale
Interval 0.1 to 3.6
|
|
Disease Activity as Measured by Disease Activity Score 28 (DAS28)
Baseline (n=28)
|
5.4 units on a scale
Interval 4.1 to 7.9
|
|
Disease Activity as Measured by Disease Activity Score 28 (DAS28)
Visit 3 (n=27)
|
3.5 units on a scale
Interval 1.9 to 5.7
|
|
Disease Activity as Measured by Disease Activity Score 28 (DAS28)
Visit 4 (n= 26)
|
2.8 units on a scale
Interval 0.9 to 5.5
|
|
Disease Activity as Measured by Disease Activity Score 28 (DAS28)
Visit 5 (n= 25)
|
2.2 units on a scale
Interval 1.3 to 4.2
|
|
Disease Activity as Measured by Disease Activity Score 28 (DAS28)
Visit 6 (n= 25)
|
1.9 units on a scale
Interval 0.4 to 4.6
|
|
Disease Activity as Measured by Disease Activity Score 28 (DAS28)
Visit 7 (n= 25)
|
1.7 units on a scale
Interval 0.5 to 2.8
|
|
Disease Activity as Measured by Disease Activity Score 28 (DAS28)
Visit 8 (n= 23)
|
1.7 units on a scale
Interval 0.5 to 3.4
|
|
Disease Activity as Measured by Disease Activity Score 28 (DAS28)
Visit 10 (n= 22)
|
1.7 units on a scale
Interval 0.0 to 3.2
|
|
Disease Activity as Measured by Disease Activity Score 28 (DAS28)
Visit 11 (n= 21)
|
2.0 units on a scale
Interval 0.1 to 5.0
|
|
Disease Activity as Measured by Disease Activity Score 28 (DAS28)
Visit 12 (n= 17)
|
2.3 units on a scale
Interval 1.0 to 4.4
|
|
Disease Activity as Measured by Disease Activity Score 28 (DAS28)
Visit 14 (n= 6)
|
1.5 units on a scale
Interval 0.1 to 5.6
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: ITT consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.
The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.
Outcome measures
| Measure |
Tocilizumab
n=27 Participants
Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
|
|---|---|
|
Number of Participants Who Achieved Remission (DAS28 < 2.6)
Visit 4 (n=26)
|
7 participants
|
|
Number of Participants Who Achieved Remission (DAS28 < 2.6)
Visit 3 (n=27)
|
3 participants
|
|
Number of Participants Who Achieved Remission (DAS28 < 2.6)
Visit 5 (n=25)
|
12 participants
|
|
Number of Participants Who Achieved Remission (DAS28 < 2.6)
Visit 6 (n=25)
|
14 participants
|
|
Number of Participants Who Achieved Remission (DAS28 < 2.6)
Visit 7 (n=25)
|
17 participants
|
|
Number of Participants Who Achieved Remission (DAS28 < 2.6)
Visit 8 (n=23)
|
16 participants
|
|
Number of Participants Who Achieved Remission (DAS28 < 2.6)
Visit 9 (n=21)
|
15 participants
|
|
Number of Participants Who Achieved Remission (DAS28 < 2.6)
Visit 10 (n=22)
|
18 participants
|
|
Number of Participants Who Achieved Remission (DAS28 < 2.6)
Visit 11 (n=21)
|
13 participants
|
|
Number of Participants Who Achieved Remission (DAS28 < 2.6)
Visit 12 (n=17)
|
7 participants
|
|
Number of Participants Who Achieved Remission (DAS28 < 2.6)
Visit 13 (n=13)
|
8 participants
|
|
Number of Participants Who Achieved Remission (DAS28 < 2.6)
Visit 14 (n=6)
|
4 participants
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: The intent-to-treat population (ITT) consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' is equal to (=) number of participants analyzed at particular point of time.
Time to DAS28 Remission was the Time in days from the first infusion of study drug to the achievement of a DAS28 score \< 2.6 units. The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.
Outcome measures
| Measure |
Tocilizumab
n=28 Participants
Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
|
|---|---|
|
Time to Das28 Remission
|
189.01 Day
Standard Error 7.053
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.
DAS28 Clinically Significant Improvement was defined as a DAS28 score reduction of at least 1.2 units from Baseline. The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.
Outcome measures
| Measure |
Tocilizumab
n=28 Participants
Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
|
|---|---|
|
Number of Participants Who Achieved a Clinically Meaningful Improvement in DAS28 (Reduction of At Least 1.2 Units)
Visit 4 (n=26)
|
20 participants
|
|
Number of Participants Who Achieved a Clinically Meaningful Improvement in DAS28 (Reduction of At Least 1.2 Units)
Visit 5 (n=25)
|
20 participants
|
|
Number of Participants Who Achieved a Clinically Meaningful Improvement in DAS28 (Reduction of At Least 1.2 Units)
Visit 14 (n=6)
|
4 participants
|
|
Number of Participants Who Achieved a Clinically Meaningful Improvement in DAS28 (Reduction of At Least 1.2 Units)
Visit 3 (n=27)
|
21 participants
|
|
Number of Participants Who Achieved a Clinically Meaningful Improvement in DAS28 (Reduction of At Least 1.2 Units)
Visit 6 (n=25)
|
22 participants
|
|
Number of Participants Who Achieved a Clinically Meaningful Improvement in DAS28 (Reduction of At Least 1.2 Units)
Visit 7 (n=25)
|
21 participants
|
|
Number of Participants Who Achieved a Clinically Meaningful Improvement in DAS28 (Reduction of At Least 1.2 Units)
Visit 8 (n=23)
|
20 participants
|
|
Number of Participants Who Achieved a Clinically Meaningful Improvement in DAS28 (Reduction of At Least 1.2 Units)
Visit 9 (n=21)
|
19 participants
|
|
Number of Participants Who Achieved a Clinically Meaningful Improvement in DAS28 (Reduction of At Least 1.2 Units)
Visit 10 (n=22)
|
20 participants
|
|
Number of Participants Who Achieved a Clinically Meaningful Improvement in DAS28 (Reduction of At Least 1.2 Units)
Visit 11 (n=21)
|
17 participants
|
|
Number of Participants Who Achieved a Clinically Meaningful Improvement in DAS28 (Reduction of At Least 1.2 Units)
Visit 12 (n=17)
|
12 participants
|
|
Number of Participants Who Achieved a Clinically Meaningful Improvement in DAS28 (Reduction of At Least 1.2 Units)
Visit 13 (n=13)
|
11 participants
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.
DAS28 low disease activity was defined as a DAS28 score reduction of at least 3.2 units from Baseline. The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.
Outcome measures
| Measure |
Tocilizumab
n=27 Participants
Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
|
|---|---|
|
Number of Participants Who Achieved Low Disease Activity (DAS28 < 3.2)
Visit 11 (n=21)
|
2 participants
|
|
Number of Participants Who Achieved Low Disease Activity (DAS28 < 3.2)
Visit 12 (n=17)
|
4 participants
|
|
Number of Participants Who Achieved Low Disease Activity (DAS28 < 3.2)
Visit 3 (n=27)
|
7 participants
|
|
Number of Participants Who Achieved Low Disease Activity (DAS28 < 3.2)
Visit 4 (n=26)
|
9 participants
|
|
Number of Participants Who Achieved Low Disease Activity (DAS28 < 3.2)
Visit 5 (n= 25)
|
7 participants
|
|
Number of Participants Who Achieved Low Disease Activity (DAS28 < 3.2)
Visit 6 (n=25)
|
7 participants
|
|
Number of Participants Who Achieved Low Disease Activity (DAS28 < 3.2)
Visit 7 (n=25)
|
4 participants
|
|
Number of Participants Who Achieved Low Disease Activity (DAS28 < 3.2)
Visit 8 (n= 23)
|
3 participants
|
|
Number of Participants Who Achieved Low Disease Activity (DAS28 < 3.2)
Visit 9 (n=21)
|
3 participants
|
|
Number of Participants Who Achieved Low Disease Activity (DAS28 < 3.2)
Visit 10 (n=22)
|
2 participants
|
|
Number of Participants Who Achieved Low Disease Activity (DAS28 < 3.2)
Visit 13 (n=13)
|
1 participants
|
|
Number of Participants Who Achieved Low Disease Activity (DAS28 < 3.2)
Visit 14 (n=6)
|
0 participants
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.
Health Assessment Questionnaire (HAQ) is a self-completed participant questionnaire specific for Rheumatoid Arthritis. 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, and 3=unable to do. To calculate HAQ, the participant must have a domain score for at least 6 out of 8 domains. The HAQ is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from baseline indicated improvement. Clinically meaningful HAQ response was defined as an improvement of at least 0.22 units from baseline in the HAQ Disability Index.
Outcome measures
| Measure |
Tocilizumab
n=28 Participants
Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
|
|---|---|
|
Number of Participants Who Achieved Clinically Meaningful Health Assessment Questionnaire Response
Visit 7 (n=25)
|
6 participants
|
|
Number of Participants Who Achieved Clinically Meaningful Health Assessment Questionnaire Response
Visit 3 (n=27)
|
7 participants
|
|
Number of Participants Who Achieved Clinically Meaningful Health Assessment Questionnaire Response
Visit 4 (n=25)
|
6 participants
|
|
Number of Participants Who Achieved Clinically Meaningful Health Assessment Questionnaire Response
Visit 5 (n= 25)
|
6 participants
|
|
Number of Participants Who Achieved Clinically Meaningful Health Assessment Questionnaire Response
Visit 6 (n=25)
|
7 participants
|
|
Number of Participants Who Achieved Clinically Meaningful Health Assessment Questionnaire Response
Visit 8 (n= 23)
|
4 participants
|
|
Number of Participants Who Achieved Clinically Meaningful Health Assessment Questionnaire Response
Visit 9 (n=21)
|
5 participants
|
|
Number of Participants Who Achieved Clinically Meaningful Health Assessment Questionnaire Response
Visit 10 (n=22)
|
4 participants
|
|
Number of Participants Who Achieved Clinically Meaningful Health Assessment Questionnaire Response
Visit 11 (n=21)
|
2 participants
|
|
Number of Participants Who Achieved Clinically Meaningful Health Assessment Questionnaire Response
Visit 12 (n=17)
|
4 participants
|
|
Number of Participants Who Achieved Clinically Meaningful Health Assessment Questionnaire Response
Visit 13 (n=12)
|
3 participants
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.
The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).
Outcome measures
| Measure |
Tocilizumab
n=28 Participants
Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
|
|---|---|
|
Changes in Participant's Fatigue Assessed Using the Mean FACIT-Fatigue Score
Visit 3 (n=27)
|
23.5 Units on a scale
|
|
Changes in Participant's Fatigue Assessed Using the Mean FACIT-Fatigue Score
Visit 4 (n=26)
|
24.1 Units on a scale
|
|
Changes in Participant's Fatigue Assessed Using the Mean FACIT-Fatigue Score
Visit 10 (n=22)
|
22.3 Units on a scale
|
|
Changes in Participant's Fatigue Assessed Using the Mean FACIT-Fatigue Score
Visit 5 (n= 25)
|
23.6 Units on a scale
|
|
Changes in Participant's Fatigue Assessed Using the Mean FACIT-Fatigue Score
Visit 6 (n=25)
|
24.0 Units on a scale
|
|
Changes in Participant's Fatigue Assessed Using the Mean FACIT-Fatigue Score
Visit 7 (n=25)
|
21.6 Units on a scale
|
|
Changes in Participant's Fatigue Assessed Using the Mean FACIT-Fatigue Score
Visit 8 (n= 23)
|
22.0 Units on a scale
|
|
Changes in Participant's Fatigue Assessed Using the Mean FACIT-Fatigue Score
Visit 9 (n=21)
|
19.1 Units on a scale
|
|
Changes in Participant's Fatigue Assessed Using the Mean FACIT-Fatigue Score
Visit 11 (n=21)
|
27.8 Units on a scale
|
|
Changes in Participant's Fatigue Assessed Using the Mean FACIT-Fatigue Score
Visit 12 (n=17)
|
27.3 Units on a scale
|
|
Changes in Participant's Fatigue Assessed Using the Mean FACIT-Fatigue Score
Visit 13 (n=13)
|
26.6 Units on a scale
|
|
Changes in Participant's Fatigue Assessed Using the Mean FACIT-Fatigue Score
Visit 14 (n=6)
|
25.6 Units on a scale
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.
The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on one end, and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue.
Outcome measures
| Measure |
Tocilizumab
n=28 Participants
Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
|
|---|---|
|
Change in Fatigue as Measured Using the Fatigue Visual Analog Scale
Visit 3 (n=27)
|
38.1 units on a scale
|
|
Change in Fatigue as Measured Using the Fatigue Visual Analog Scale
Visit 4 (n=26)
|
32.3 units on a scale
|
|
Change in Fatigue as Measured Using the Fatigue Visual Analog Scale
Visit 5 (n= 25)
|
29.0 units on a scale
|
|
Change in Fatigue as Measured Using the Fatigue Visual Analog Scale
Visit 6 (n=25)
|
20.1 units on a scale
|
|
Change in Fatigue as Measured Using the Fatigue Visual Analog Scale
Visit 7 (n=25)
|
14.4 units on a scale
|
|
Change in Fatigue as Measured Using the Fatigue Visual Analog Scale
Visit 8 (n= 23)
|
18.0 units on a scale
|
|
Change in Fatigue as Measured Using the Fatigue Visual Analog Scale
Visit 9 (n=21)
|
13.1 units on a scale
|
|
Change in Fatigue as Measured Using the Fatigue Visual Analog Scale
Visit 10 (n=22)
|
20.7 units on a scale
|
|
Change in Fatigue as Measured Using the Fatigue Visual Analog Scale
Visit 11 (n=21)
|
19.1 units on a scale
|
|
Change in Fatigue as Measured Using the Fatigue Visual Analog Scale
Visit 12 (n=17)
|
23.9 units on a scale
|
|
Change in Fatigue as Measured Using the Fatigue Visual Analog Scale
Visit 13 (n=13)
|
26.3 units on a scale
|
|
Change in Fatigue as Measured Using the Fatigue Visual Analog Scale
Visit 14 (n=6)
|
32.0 units on a scale
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Safety population included all participants who had received at least one dose of study medication.
An adverse event (AE) is defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event.
Outcome measures
| Measure |
Tocilizumab
n=28 Participants
Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
|
|---|---|
|
Number of Participants With Any Adverse Event and Serious Adverse Event
Any AE
|
4 participants
|
|
Number of Participants With Any Adverse Event and Serious Adverse Event
Any SAE
|
2 participants
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Safety population included all participants who had received at least one dose of study medication.
It included participants who discontinued from the study due to occurrence of AE or SAE.
Outcome measures
| Measure |
Tocilizumab
n=28 Participants
Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
|
|---|---|
|
Number of Participants With AE or SAE Related Discontinuation of Tocilizumab
|
2 participants
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.
ACR20, ACR50, ACR70, and ACR90 are defined as greater than or equal to (≥)20 percent (%), ≥50%, ≥70%, or ≥90% improvement, respectively, in swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints). It also comprises ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in 3 of the following 5 assessments: Patient's Global Assessment of Pain (VAS); Patient's Global Assessment of Disease Activity (VAS); Investigator/Physician's Global Assessment of Disease Activity (VAS); participant's assessment of disability measured by the Health Assessment Questionnaire Disability Index (HAQ-DI); or acute phase reactant (ESR or C-reactive protein \[CRP\]).
Outcome measures
| Measure |
Tocilizumab
n=28 Participants
Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
|
|---|---|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR20: Visit 9 (n=21)
|
0 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR70: Visit 3 (n=27)
|
7 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR70: Visit 7 (n=25)
|
3 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR70: Visit 13 (n=13)
|
5 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR20: Visit 3 (n=27)
|
3 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR20: Visit 4 (n=26)
|
4 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR20:Visit 5 (n=25)
|
1 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR20: Visit 6 (n=25)
|
1 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR20: Visit 7 (n=25)
|
0 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR20: Visit 8 (n=23)
|
0 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR20: Visit 10 (n=22)
|
0 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR20: Visit 11 (n=21)
|
2 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR20: Visit 12 (n=17)
|
1 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR20: Visit 13 (n=13)
|
0 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR20: Visit 14 (n=6)
|
0 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR50: Visit 3 (n=27)
|
11 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR50: Visit 4 (n=26)
|
7 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR50:Visit 5 (n=25)
|
1 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR50: Visit 6 (n=25)
|
1 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR50: Visit 7 (n=25)
|
2 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR50: Visit 8 (n=23)
|
1 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR50: Visit 9 (n=21)
|
1 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR50: Visit 10 (n=22)
|
1 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR50: Visit 11 (n=21)
|
0 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR50: Visit 12 (n=17)
|
0 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR50: Visit 13 (n=13)
|
1 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR50: Visit 14 (n=6)
|
1 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR70: Visit 4 (n=26)
|
10 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR70:Visit 5 (n=25)
|
14 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR70: Visit 6 (n=25)
|
8 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR70: Visit 8 (n=23)
|
6 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR70: Visit 9 (n=21)
|
5 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR70: Visit 10 (n=22)
|
6 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR70: Visit 11 (n=21)
|
6 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR70: Visit 12 (n=17)
|
5 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR70: Visit 14 (n=6)
|
0 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR90: Visit 3 (n=27)
|
2 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR90: Visit 4 (n=26)
|
3 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR90:Visit 5 (n=25)
|
8 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR90: Visit 6 (n=25)
|
13 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR90: Visit 7 (n=25)
|
18 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR90: Visit 8 (n=23)
|
15 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR90: Visit 9 (n=21)
|
14 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR90: Visit 10 (n=22)
|
14 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR90: Visit 11 (n=21)
|
12 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR90: Visit 12 (n=17)
|
10 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR90: Visit 13 (n=13)
|
5 participants
|
|
Number of Participants Who Achieved ACR20, ACR50, ACR70 and ACR90 Response
ACR90: Visit 14 (n=6)
|
3 participants
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.
CRP is a biological marker of inflammation. A reduction in CRP indicates improvement. It is measured in milligram per liter (mg/L).
Outcome measures
| Measure |
Tocilizumab
n=28 Participants
Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
|
|---|---|
|
Number of Participants With C-Reactive Protein Abnormality
Baseline (n=28)
|
16 mg/L
|
|
Number of Participants With C-Reactive Protein Abnormality
Visit 3 (n=27)
|
8 mg/L
|
|
Number of Participants With C-Reactive Protein Abnormality
Visit 4 (n=26)
|
7 mg/L
|
|
Number of Participants With C-Reactive Protein Abnormality
Visit 5 (n=25)
|
2 mg/L
|
|
Number of Participants With C-Reactive Protein Abnormality
Visit 6 (n=25)
|
5 mg/L
|
|
Number of Participants With C-Reactive Protein Abnormality
Visit 7 (n=25)
|
6 mg/L
|
|
Number of Participants With C-Reactive Protein Abnormality
Visit 8 (n=23)
|
7 mg/L
|
|
Number of Participants With C-Reactive Protein Abnormality
Visit 9 (n=21)
|
7 mg/L
|
|
Number of Participants With C-Reactive Protein Abnormality
Visit 10 (n=22)
|
9 mg/L
|
|
Number of Participants With C-Reactive Protein Abnormality
Visit 11 (n=21)
|
9 mg/L
|
|
Number of Participants With C-Reactive Protein Abnormality
Visit 12 (n=17)
|
8 mg/L
|
|
Number of Participants With C-Reactive Protein Abnormality
Visit 13 (n=13)
|
7 mg/L
|
|
Number of Participants With C-Reactive Protein Abnormality
Visit 14 (n=6)
|
2 mg/L
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.
ESR is an acute phase reactant and is a measure of inflammation. It is measured in millimeter per hour (mm/hr).
Outcome measures
| Measure |
Tocilizumab
n=28 Participants
Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
|
|---|---|
|
Number of Participants With Erythrocyte Sedimentation Rate Abnormality
Visit 3 (n=27)
|
5 participants
|
|
Number of Participants With Erythrocyte Sedimentation Rate Abnormality
Baseline (n=28)
|
13 participants
|
|
Number of Participants With Erythrocyte Sedimentation Rate Abnormality
Visit 4 (n=26)
|
3 participants
|
|
Number of Participants With Erythrocyte Sedimentation Rate Abnormality
Visit 5 (n=25)
|
1 participants
|
|
Number of Participants With Erythrocyte Sedimentation Rate Abnormality
Visit 6 (n=25)
|
0 participants
|
|
Number of Participants With Erythrocyte Sedimentation Rate Abnormality
Visit 7 (n=25)
|
1 participants
|
|
Number of Participants With Erythrocyte Sedimentation Rate Abnormality
Visit 8 (n=23)
|
2 participants
|
|
Number of Participants With Erythrocyte Sedimentation Rate Abnormality
Visit 9 (n=21)
|
3 participants
|
|
Number of Participants With Erythrocyte Sedimentation Rate Abnormality
Visit 10 (n=22)
|
0 participants
|
|
Number of Participants With Erythrocyte Sedimentation Rate Abnormality
Visit 11 (n=21)
|
0 participants
|
|
Number of Participants With Erythrocyte Sedimentation Rate Abnormality
Visit 12 (n=17)
|
0 participants
|
|
Number of Participants With Erythrocyte Sedimentation Rate Abnormality
Visit 13 (n=13)
|
2 participants
|
|
Number of Participants With Erythrocyte Sedimentation Rate Abnormality
Visit 14 (n=6)
|
1 participants
|
Adverse Events
Tocilizumab
Serious adverse events
| Measure |
Tocilizumab
n=28 participants at risk
Participants received Tocilizumab 8 milligram per kilogram (mg/kg) intravenously (IV) every 4 weeks for a total of 6 infusions up to Week 20. A follow-up visit at Week 24 was planned, after which evaluation of responders was done. Good/moderate EULAR responders continued receiving Tocilizumab every 4 weeks, till 1 year treatment or commercial availability.
|
|---|---|
|
Vascular disorders
Hypotension
|
3.6%
1/28 • Up to 1 Year
All participants enrolled were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
3.6%
1/28 • Up to 1 Year
All participants enrolled were included in the safety analysis.
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.6%
1/28 • Up to 1 Year
All participants enrolled were included in the safety analysis.
|
|
Blood and lymphatic system disorders
Thrombocytpenia
|
3.6%
1/28 • Up to 1 Year
All participants enrolled were included in the safety analysis.
|
Other adverse events
| Measure |
Tocilizumab
n=28 participants at risk
Participants received Tocilizumab 8 milligram per kilogram (mg/kg) intravenously (IV) every 4 weeks for a total of 6 infusions up to Week 20. A follow-up visit at Week 24 was planned, after which evaluation of responders was done. Good/moderate EULAR responders continued receiving Tocilizumab every 4 weeks, till 1 year treatment or commercial availability.
|
|---|---|
|
Vascular disorders
Hypertension
|
3.6%
1/28 • Up to 1 Year
All participants enrolled were included in the safety analysis.
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.6%
1/28 • Up to 1 Year
All participants enrolled were included in the safety analysis.
|
|
Blood and lymphatic system disorders
Low hemoglobin
|
3.6%
1/28 • Up to 1 Year
All participants enrolled were included in the safety analysis.
|
|
Blood and lymphatic system disorders
Low red blood cells
|
3.6%
1/28 • Up to 1 Year
All participants enrolled were included in the safety analysis.
|
|
Blood and lymphatic system disorders
Epistaxis
|
3.6%
1/28 • Up to 1 Year
All participants enrolled were included in the safety analysis.
|
|
Infections and infestations
Urinary tract infection
|
3.6%
1/28 • Up to 1 Year
All participants enrolled were included in the safety analysis.
|
|
Eye disorders
Diplopia
|
3.6%
1/28 • Up to 1 Year
All participants enrolled were included in the safety analysis.
|
|
Eye disorders
Dry eye
|
3.6%
1/28 • Up to 1 Year
All participants enrolled were included in the safety analysis.
|
|
General disorders
Infusion site pain
|
3.6%
1/28 • Up to 1 Year
All participants enrolled were included in the safety analysis.
|
|
General disorders
Headache & dizziness
|
3.6%
1/28 • Up to 1 Year
All participants enrolled were included in the safety analysis.
|
|
General disorders
Headache & generalized body ache
|
3.6%
1/28 • Up to 1 Year
All participants enrolled were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
3.6%
1/28 • Up to 1 Year
All participants enrolled were included in the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
3.6%
1/28 • Up to 1 Year
All participants enrolled were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.6%
1/28 • Up to 1 Year
All participants enrolled were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Flu
|
3.6%
1/28 • Up to 1 Year
All participants enrolled were included in the safety analysis.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.6%
1/28 • Up to 1 Year
All participants enrolled were included in the safety analysis.
|
Additional Information
Roche Trial Information Hotline
F. Hoffmann-La Roche AG
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